Osteoarthritis, or OA, is one of the most common joint diseases worldwide, affecting millions of people, especially those over 65. It is a chronic condition that gradually damages joints, causing pain, stiffness, and reduced mobility. OA doesn’t just impact knees and hips—it can affect finger joints, thumbs, and even the spine. The symptoms are familiar: pain that worsens with movement, stiffness after sitting or resting, limited range of motion, and sometimes noticeable changes in the joints themselves. Unfortunately, OA is not just uncomfortable—it also carries a significant economic burden due to long-term treatment needs.
Traditionally, OA treatment has focused on managing symptoms, particularly pain. Anti-inflammatory medications, physical therapy, and lifestyle changes are standard approaches. While these strategies can improve quality of life, they do not address the root problem: the joint tissues themselves, including cartilage, ligaments, and menisci, cannot heal on their own. Once these tissues are damaged, OA progression continues, leading to further joint degeneration.
In this review, Harrell et al. evaluate current knowledge and future perspectives on the molecular and cellular mechanisms underlying the beneficial effects of MSCs in the treatment of OA.
The Role of Inflammation in Osteoarthritis
For many years, OA was thought to be simply a “wear-and-tear” disease. However, recent research has shown that inflammation plays a key role in the progression of OA. The early stages of OA involve the activation of the body’s immune system. Cells such as natural killer cells, macrophages, and mast cells respond to joint damage and produce molecules that can cause further tissue breakdown. Over time, the adaptive immune system becomes involved, with T cells and B cells contributing to chronic inflammation. These immune cells can produce autoantibodies, further harming cartilage and maintaining a cycle of inflammation.
This understanding of OA as an inflammatory disease has shifted the focus of treatment research. The goal is no longer just to relieve pain but also to reduce inflammation and encourage tissue regeneration.
Why Mesenchymal Stem Cells Are Promising
Mesenchymal stem cells, or MSCs, have emerged as one of the most promising tools in the fight against OA. These cells can be obtained from a variety of tissues, including bone marrow, fat, synovial tissue, and even muscles. MSCs have two key advantages that make them particularly useful in OA treatment. First, they can differentiate into chondrocytes—the cells that make cartilage—allowing them to potentially regenerate damaged joint tissue. Second, MSCs have immunomodulatory properties, meaning they can calm inflammation and reduce the immune system’s attack on joint tissues.
MSCs are relatively easy to obtain and grow in the lab. They can proliferate quickly, maintain their ability to differentiate even after multiple cell divisions, and are less likely to trigger immune rejection because they express low levels of certain immune molecules. These properties make MSCs a versatile and powerful option for treating OA.
How MSCs Help Repair Cartilage
For MSCs to be effective in repairing joints, they must turn into healthy cartilage cells. This process, called chondrogenic differentiation, is influenced by a variety of growth factors and environmental conditions. Proteins such as TGF-β, IGF-1, BMP-6, and others help MSCs develop into chondrocytes. Physical conditions also play a role: lower oxygen levels can encourage cartilage formation, and specialized scaffolds, gels, or hydrogels can provide structural support for growing tissue.
When MSCs successfully differentiate into chondrocytes, they produce important cartilage components like type II collagen and proteoglycans. Scientists are able to measure these markers in lab cultures to confirm that MSCs are developing into cartilage cells properly. Importantly, MSCs can do this without becoming hypertrophic, forming healthy cartilage rather than abnormal tissue.
MSCs and Inflammation Control
In addition to creating new cartilage, MSCs can help calm inflammation in OA joints. They interact with immune cells in two ways: directly through cell-to-cell contact and indirectly by releasing signaling molecules. MSCs can convert inflammatory macrophages into anti-inflammatory types, reduce the activity of natural killer cells, suppress autoreactive B cells, and promote regulatory T cells that help control immune responses.
MSCs release several molecules that contribute to this effect, including TSG-6, prostaglandin E2, and indoleamine 2,3-dioxygenase (IDO). These molecules reduce the production of inflammatory cytokines and encourage tissue repair.
MSC-Derived Exosomes and New Discoveries
Recent research has uncovered another exciting mechanism for MSC therapy: exosomes. These tiny vesicles, released by MSCs, carry proteins, microRNAs, and other molecules that influence surrounding cells. Exosomes from MSCs can promote chondrocyte growth, reduce apoptosis (cell death), and aid cartilage repair. Some studies have even identified specific microRNAs and long noncoding RNAs in exosomes that are especially effective in promoting cartilage regeneration.
In addition, MSCs can induce autophagy in damaged cartilage cells, a process that helps protect cells under stress. By enhancing autophagy, MSCs improve chondrocyte survival and support tissue repair, providing yet another therapeutic benefit.
Clinical Trials in Humans
Building on promising animal data, many clinical trials have explored MSC therapy in humans with OA. Bone marrow-derived MSCs (BM-MSCs) were among the first to be tested. In one early study, patients with knee OA received autologous BM-MSCs embedded in collagen gels. Over several weeks and months, the treated joints showed signs of cartilage repair and improved tissue quality compared to untreated controls. Patients reported reduced pain and improved function, and follow-up studies have shown that benefits can last for years.
Adipose-derived MSCs (AT-MSCs) have also been widely studied. These cells are easier to obtain in large quantities and have strong immunomodulatory effects. Clinical trials with AT-MSCs demonstrated improvements in pain, function, and cartilage health, even at relatively low doses. Some studies combined BM-MSCs and AT-MSCs to take advantage of both regenerative and immunosuppressive properties, demonstrating greater benefits for patients with moderate OA.
While most studies have focused on intra-articular injections directly into joints, percutaneous injections using the patient’s own growth factors have also shown promise. These methods rely on MSCs’ natural ability to home to damaged tissue, though controlling their migration remains a challenge. Using injectable carriers, such as hyaluronic acid, can improve MSC attachment and integration into damaged cartilage.
Allogeneic MSCs and Evolving Approaches to Cartilage Repair
Autologous MSCs are highly effective, but harvesting them can be invasive, and their regenerative capacity may be limited in patients with advanced OA. Allogeneic MSCs, derived from healthy donors, offer an “off-the-shelf” alternative. Early clinical trials using allogeneic MSCs have shown safety and some therapeutic effects, though immune responses can limit their long-term persistence. Strategies such as encapsulating MSCs in protective biomaterials may help prolong their survival and improve outcomes.
Researchers are also exploring ways to stimulate the body’s own MSCs to repair cartilage. Cell-free formulations such as BIOF2 can promote the expansion and differentiation of endogenous MSCs. Innovative surgical techniques, such as synovium brushing, are being tested to release MSCs from joint tissues, offering new avenues for cartilage regeneration without the need for cell transplantation.
The Future of Osteoarthritis Treatment
Osteoarthritis has long been a challenging condition with limited treatment options. Traditional therapies focus on managing symptoms but cannot repair damaged joints. Mesenchymal stem cells offer a promising new approach, capable of both regenerating cartilage and reducing inflammation. Research in animal models and human clinical trials has shown that MSCs can engraft in joints, promote tissue repair, modulate immune responses, and improve patient function.
Although challenges remain, including optimizing cell sources, doses, and delivery methods, the future of MSC therapy in OA looks bright. Ongoing studies are exploring ways to expand endogenous MSCs, improve allogeneic MSC survival, and harness MSC-derived exosomes for regenerative therapy. As our understanding of MSC biology grows, Harrell et al. believe these therapies may offer lasting relief and meaningful joint repair for millions of OA patients worldwide.
Source: Harrell, C. R., Simovic Markovic, B., Fellabaum, C., Arsenijevic, A., & Volarevic, V. (2019). Mesenchymal stem cell-based therapy of osteoarthritis: Current knowledge and future perspectives. Biomedicine & Pharmacotherapy, 109, 2318–2326. https://doi.org/10.1016/j.biopha.2018.11.099
Low back pain (LBP) is one of the most common health problems worldwide, affecting nearly 60 to 80 percent of adults at some point in their lives. It’s the second most frequent reason people visit a doctor and one of the leading causes of work disability. For many, the costs aren’t just personal—they include substantial healthcare expenses and lost productivity. A large portion of chronic low back pain is linked to problems with the intervertebral discs, the soft cushions that sit between the vertebrae. When these discs degenerate, they can lose height, dry out, and develop tears, leading to persistent pain and reduced function.
Traditionally, people with disc-related LBP have relied on a mix of pain medications, physical therapy, and sometimes surgery. While these approaches can help, they often provide only temporary relief and may come with unwanted side effects. Medications, especially opioids, can lead to dependency or other complications. Physical therapy offers modest benefits for many, and surgeries like discectomy or spinal fusion have inconsistent outcomes and may involve long recovery periods.
This study provides initial evidence of the safety and efficacy of low-dose autologous adipose-derived mesenchymal stem cells (ADMSCs) for discogenic LBP.
Mesenchymal Stem Cells and Disc Regeneration
Stem cells, particularly mesenchymal stem cells (MSCs), have gained attention for their ability to support tissue repair. MSCs can be obtained from several sources, including bone marrow, umbilical cord tissue, and fat (adipose tissue). They release growth factors, cytokines, and other molecules that can reduce inflammation, prevent cell death, and stimulate the body’s natural repair processes. Rather than becoming new disc cells themselves, MSCs create an environment that promotes healing within the damaged disc.
Bone marrow-derived MSCs were some of the first to be studied for disc degeneration, but harvesting them can be painful and yield relatively few stem cells. Adipose tissue, by contrast, provides an abundant source of MSCs that are easier to collect and expand for therapy. Early research using bone marrow and adipose-derived MSCs has shown promise in improving pain and function in people with disc-related low back pain. However, questions remained about the safety of these treatments and whether lower doses of adipose-derived stem cells could still be effective.
The Study: Testing Low-Dose Adipose-Derived MSCs
This study by Bates et al. aimed to evaluate the safety and effectiveness of low-dose autologous adipose-derived mesenchymal stem cells (ADMSCs) for the treatment of discogenic low back pain. “Autologous” means that the stem cells come from the patient’s own body, reducing the risk of rejection or other immune reactions. The study included nine participants with chronic low back pain caused by degeneration of a single lumbar disc.
Each participant received an intradiscal injection of 10 million ADMSCs, with the option to repeat the injection six months later if needed. Over the following year, participants were closely monitored for any adverse effects and changes in pain, function, and quality of life. MRI scans were also used to examine the discs themselves.
Safety and Tolerability of ADMSC Injections
One of the most important findings from this study was safety. None of the participants experienced unexpected or serious adverse events related to the treatment. Only one participant experienced a temporary flare in pain after the injection, which was managed with standard pain medications. Overall, the procedure was well tolerated and demonstrated a strong safety profile, which is critical for any new therapy.
Pain Relief and Functional Improvements
The majority of participants reported meaningful improvements in their pain levels. After 12 months, seven out of nine participants (78%) reported reductions in average pain, and six participants (67%) reported improvements in their most severe pain episodes. Clinically significant improvements—those that made a real difference in daily life—were observed in most participants.
Functionally, the benefits were clear as well. Five participants (56%) reported being able to work more effectively, and three participants were able to reduce their use of pain medications. Measures of quality of life, including the ability to perform daily activities and self-care, also improved for most participants. Importantly, none of the participants reported any worsening of their condition during the study period.
MRI Findings and Disc Health
MRI scans at 12 months showed that the treated discs remained stable. There was no further loss of disc height or progression of degenerative changes in the vertebrae. In some cases, annular fissures—the tears in the outer layer of the disc—had partially or fully healed. Two participants also showed a reduction in disc protrusion, in which part of the disc protrudes outward. While it’s unclear whether these changes were directly caused by the stem cell therapy or natural healing processes, the stabilization of the discs was a positive finding.
Who Benefits Most?
Interestingly, the study suggested that certain characteristics might predict better outcomes. Participants with Modic type 2 changes (a type of vertebral bone change seen on MRI) and no annular tears seemed to respond particularly well. Those with annular tears or other types of changes did not experience as much benefit. While the study was small, this finding suggests the potential for more targeted treatment in the future, in which patients are selected based on specific disc characteristics.
Comparing Stem Cell Therapy to Traditional Treatments
Compared to conventional approaches, stem cell therapy offers several potential advantages. Medications, particularly opioids, provide limited relief and carry significant risks. Physical therapy can be helpful, but improvements are usually modest. Surgical interventions can be effective for severe cases, but they are invasive, carry risks, and often require long recovery periods. Stem cell therapy, by contrast, is minimally invasive and may offer both pain relief and functional improvements, with a strong safety profile.
Other studies have explored similar approaches, using higher doses of MSCs or combining them with carriers such as hyaluronic acid. This study’s use of a lower dose in a simple isotonic solution is significant because it shows that even a relatively small number of stem cells can produce meaningful results without additional substances. This could make treatment faster, simpler, and more cost-effective.
Limitations and Considerations
While the results are promising, it’s important to recognize the study’s limitations. The sample size was small, and there was no control group, so it’s difficult to make definitive conclusions about efficacy. The study also excluded participants with more severe or multi-level disc degeneration, so the findings may not apply to all patients with chronic low back pain.
Another consideration is the variability in response. Not all participants experienced the same level of benefit, and some improvements were modest. The timing of additional doses may also matter; in this study, those who did not achieve significant improvement after six months generally did not see large gains at 12 months, even with a second injection.
The Potential of ADMSC Therapy
Despite these limitations, the study provides encouraging evidence that low-dose ADMSC therapy is safe and has the potential to reduce pain and improve function in people with discogenic low back pain. The therapy was well-tolerated, and most participants experienced meaningful improvements in pain, daily function, and quality of life. MRI results also suggested that disc health could be maintained or even partially restored.
For patients with specific characteristics, such as Modic type 2 changes without annular tears, stem cell therapy may be particularly beneficial. Future studies with larger participant groups, control arms, and longer follow-up will help to confirm these findings and better define which patients are most likely to benefit.
Clinical Implications and Future Directions for ADMSC Therapy in Discogenic Low Back Pain
Chronic low back pain remains a challenging condition with limited effective treatments. Current approaches, including medication, physical therapy, and surgery, often provide only partial relief and can come with significant risks. Stem cell therapy, particularly using adipose-derived mesenchymal stem cells, offers a new avenue for treating discogenic pain.
This study demonstrated that low-dose ADMSC injections are safe and well tolerated, and are associated with meaningful improvements in pain, function, and quality of life for most participants. MRI scans suggested stabilization and partial healing of the discs, and certain patient characteristics may help predict who will benefit most.
While more research is needed, the findings are promising. Stem cell therapy could become a valuable treatment option for patients with discogenic low back pain, offering relief without the risks and limitations of traditional approaches. For individuals struggling with chronic disc-related pain, ADMSC therapy represents a potential step toward better function, less pain, and improved quality of life.
Source: Bates D, Vivian D, Freitag J, Wickham J, Mitchell B, Verrills P, Shah K, Boyd R, Federman D, Barnard A, O’Connor L, Young JF. Low-dose mesenchymal stem cell therapy for discogenic pain: safety and efficacy results from a 1-year feasibility study. Future Sci OA. 2022 Apr 21;8(5):FSO794. doi: 10.2144/fsoa-2021-0155. PMID: 35662742; PMCID: PMC9136638.
Autoimmune diseases are a group of complex conditions in which the immune system mistakenly attacks the body’s own tissues. Examples include Crohn’s disease, systemic lupus erythematosus, rheumatoid arthritis, scleroderma, and psoriasis. These diseases are chronic and often progressive, affecting multiple organs and causing long-term damage. Patients with autoimmune diseases experience inflammation and tissue injury that can lead to permanent organ dysfunction. Current treatments, including anti-inflammatory drugs, immunosuppressants, and biologic therapies, aim to control symptoms and prevent disease progression. However, these treatments often fall short, sometimes failing to maintain remission or causing significant side effects over time.
The limitations of existing therapies have prompted researchers to explore alternative strategies, and stem cell therapy has emerged as a promising option.
This study analyzes trends and challenges in clinical trials of stem cell therapy for autoimmune diseases.
Understanding Autoimmune Diseases
Autoimmune diseases vary widely in their clinical presentation and the parts of the body they affect. For example, rheumatoid arthritis primarily targets joints, leading to chronic pain and swelling, while scleroderma involves fibrosis and vascular problems that affect the skin and internal organs. Inflammatory bowel diseases, such as Crohn’s disease and ulcerative colitis, result from impaired intestinal barrier function and abnormal immune responses in the gut. Systemic lupus erythematosus involves the production of autoantibodies that deposit in multiple organs, causing inflammation and tissue damage. Psoriasis affects the skin through immune cell interactions that drive excessive inflammation. Globally, autoimmune diseases impact over one billion people, with rising rates in developing countries due to environmental changes, lifestyle factors, and better diagnostic capabilities.
Treating autoimmune diseases typically requires balancing immediate symptom relief with long-term disease management. Anti-inflammatory drugs and glucocorticoids help control acute symptoms, while immunosuppressants and biologics maintain disease remission. Newer therapies, including small-molecule inhibitors targeting specific immune pathways like JAK-STAT, have been developed for patients who do not respond to conventional treatments. Despite these advances, significant challenges remain. Long-term use of medications can cause side effects such as metabolic syndrome, increased infection risk, or cardiovascular complications. Existing therapies often suppress immune responses but cannot reverse tissue damage or fibrosis, leaving patients at risk of permanent organ impairment even after symptoms improve.
The Role of Stem Cells in Autoimmune Disease Treatment
Stem cell therapy offers an innovative approach to address the limitations of traditional treatments. Different types of stem cells are being studied for their ability to modulate the immune system and repair damaged tissues. Mesenchymal stem cells, or MSCs, are among the most researched due to their immunomodulatory and regenerative properties. MSCs secrete molecules like TGF-β, prostaglandin E2, and IDO, along with exosomes containing regulatory microRNAs, which help suppress overactive immune responses while promoting regulatory immune cells that maintain balance. MSCs can also migrate to inflamed tissues and differentiate into functional cells, directly contributing to tissue repair.
Hematopoietic stem cell transplantation, or HSCT, works differently. It involves high-dose immunosuppression to remove the faulty immune system, followed by the reintroduction of stem cells to rebuild immune tolerance. HSCT has shown long-term remission potential in diseases such as scleroderma and multiple sclerosis. Induced pluripotent stem cells, or iPSCs, can be engineered to produce specific immune-regulating cells or to regenerate damaged tissues, offering precise treatment options for autoimmune conditions.
Despite these promising approaches, stem cell therapy faces challenges in clinical translation. Personalized treatments, including autologous iPSC preparation or selection of allogeneic MSCs, are complex and costly. Standardizing procedures for cell culture, differentiation, and quality control increases costs. Additionally, long-term safety data are limited, particularly regarding immune reactions to allogeneic cells. Thorough research and standardized protocols are needed to ensure that stem cell therapy can be widely adopted safely and effectively.
Trends in Stem Cell Clinical Trials for Autoimmune Diseases
Recent analyses of global clinical trial data from 2006 to 2025 provide insights into the current landscape of stem cell therapy for autoimmune diseases. Out of more than 1,500 trials, 244 met strict inclusion criteria for detailed analysis. Most trials are in early stages, with 83.6% in Phase I or Phase II. Crohn’s disease, systemic lupus erythematosus, and scleroderma are the most frequently studied conditions, highlighting high clinical interest in these diseases. The United States and China lead in the number of trials, reflecting strong governmental and institutional support for stem cell research. Academic institutions fund nearly half of the studies, though collaboration with industry remains limited, which may slow the translation of research findings into clinical practice.
The trials focus on key therapeutic strategies, including immune modulation, tissue repair, and suppression of overactive cell proliferation. Disease-specific differences in cell sources and delivery methods are evident. MSCs are the predominant stem cell type used, largely due to their strong immunoregulatory properties, safety, and allogeneic use. HSCT is applied in severe or refractory cases, while pluripotent stem cells like iPSCs are less common due to ethical concerns, tumor risk, and the need for directed differentiation.
Challenges in Clinical Translation
A major barrier to stem cell therapy is the variability in cell preparation. Differences in cell source, harvesting techniques, expansion protocols, and quality control can impact treatment outcomes. For example, MSCs derived from bone marrow, adipose tissue, or umbilical cord each have distinct properties and applications. Standardizing cell preparation and testing, including assessing cell viability, potency, and safety, is critical to improving consistency across studies.
Financial and logistical challenges also limit the widespread use of stem cell therapies. Autologous treatments are expensive and labor-intensive, while allogeneic therapies require careful immunological matching to prevent rejection. Regulatory hurdles add further complexity, as safety and efficacy must be thoroughly demonstrated before treatments can become mainstream. Long-term follow-up studies are particularly important for evaluating the durability of treatment effects and for monitoring potential adverse events.
Advances in Targeted Therapies and Delivery Methods
Clinical trials have explored novel targets and delivery strategies to enhance the effectiveness of stem cell therapy. Immune targets like CD19 and CD52 are used in therapies that aim to selectively deplete pathogenic immune cells, while growth factors secreted by stem cells support tissue repair. The routes of administration vary based on disease and cell type. MSCs are often delivered intravenously for systemic immune modulation, whereas localized injections are used for tissue repair. HSCT is uniformly administered intravenously, and epithelial stem cells are transplanted directly to target tissues. Emerging technologies, such as MSCs combined with drug-loaded nanoparticles or injectable hydrogels, are being developed to extend therapeutic effects and reduce the frequency of treatments.
Clinical Outcomes and Effectiveness
Stem cell therapies have demonstrated promising results in several autoimmune diseases. In systemic lupus erythematosus, allogeneic MSCs have induced complete or partial remission in roughly half of patients with refractory disease. HSCT in SLE and scleroderma shows long-term disease modification, with improvements in organ function and symptom relief. In Crohn’s disease, local MSC injections have achieved high rates of fistula healing, whereas HSCT offers limited benefits due to its associated risks. Rheumatoid arthritis studies have shown short-term improvements in patients who have failed conventional therapies, indicating the potential of MSC therapy as an alternative treatment for refractory cases.
The source of stem cells can influence treatment outcomes. Umbilical cord-derived MSCs are particularly useful in systemic lupus erythematosus due to their immunomodulatory potential and ability to differentiate into multiple cell types. Bone marrow- and adipose-derived MSCs are commonly used for localized tissue repair, such as in Crohn’s disease. Ongoing research aims to refine stem cell selection, identify subpopulations with optimal therapeutic effects, and develop precision therapies tailored to individual patients.
Future Directions in Stem Cell Therapy
The future of stem cell therapy in autoimmune diseases lies in technological innovation, international collaboration, and precision medicine. Advances in gene editing, such as CRISPR-Cas9, allow for enhanced stem cell function and tracking, while multi-omics analyses can help identify the most effective cell subpopulations. Establishing stem cell banks, similar to Japan’s iPSC Bank, can address limitations of autologous stem cells and facilitate wider access. Precision medicine approaches, including biomarker-based patient stratification, real-time monitoring of treatment response, and integration of genetic and microbiome data, can help tailor therapies to individual needs. Large-scale, multicenter clinical studies and real-world data collection will be crucial for assessing the safety and effectiveness of stem cell therapies.
Combining stem cell therapy with other treatments, improving delivery methods, and targeting multiple pathways simultaneously may further enhance outcomes. For example, MSCs combined with drug-loaded nanoparticles or hydrogels can provide sustained anti-inflammatory effects, while engineered stem cells can selectively regulate immune responses and repair damaged tissues. By integrating these strategies, future therapies may offer safer, more effective, and cost-efficient options for patients with autoimmune diseases.
Implications for Clinical Practice and Future Research
Stem cell therapy represents a promising frontier in the treatment of autoimmune diseases. Clinical trials indicate significant potential for conditions such as Crohn’s disease, systemic lupus erythematosus, and scleroderma, though most studies are still in early stages. Current therapies focus on immune regulation, tissue repair, and the suppression of overactive cells, but challenges such as high costs, limited long-term safety data, and variability in cell preparation persist. Technological innovation, global collaboration, and precision medicine will be essential to overcome these challenges. With continued research and clinical development, stem cell therapy has the potential to provide patients with safer, more effective, and individualized treatment options that go beyond symptom management to address the underlying mechanisms of autoimmune disease.
Source: Chen Y, Li X, Zhang J, Peng J, Huang F, Bao J, Fan Y and Huang S (2025) Global clinical trials on stem cell therapy for autoimmune diseases: trends and future directions. Front. Immunol. 16:1616231. doi: 10.3389/fimmu.2025.1616231
Mesenchymal stromal cell therapy, often called MSC therapy, has become one of the most widely studied approaches in regenerative and cellular medicine. Over the past two decades, researchers have explored its potential to treat a wide range of inflammatory and immune-related conditions, including heart disease, lung injury, autoimmune disorders, and complications following cancer treatment.
As interest grows and more patients are invited to participate in clinical trials, one question becomes increasingly important: Is MSC therapy safe? This large, updated scientific review provides reassuring answers, demonstrating that MSC therapy continues to show a strong, favorable safety profile across thousands of patients and dozens of high-quality clinical trials.
As part of this review, Thompson et al. explain what MSC therapy is, why safety is such a critical concern, how researchers evaluated safety across many studies, and what the findings mean for patients, families, clinicians, and regulators.
Mesenchymal Stromal Cells and Their Therapeutic Role
Mesenchymal stromal cells are multipotent cells that can be collected from adult tissues such as bone marrow, adipose tissue, and other sources. They were first described in the 1970s and have since gained attention for their ability to interact with the immune system and respond to inflammation.
Unlike embryonic stem cells, MSCs have a limited ability to turn into different cell types. Instead, their primary therapeutic value appears to lie in their ability to communicate with surrounding tissues. MSCs release bioactive molecules that help regulate immune responses, reduce excessive inflammation, and promote healing. They also migrate toward areas of injury or inflammation, making them attractive candidates for conditions where inflammation plays a central role.
Preclinical research, including animal studies, has shown promising results in conditions such as acute lung injury, sepsis, and heart attack. These findings have led to a growing number of human clinical trials evaluating both safety and potential benefits.
Safety Considerations for Mesenchymal Stromal Cell Therapy
Any therapy that involves living cells raises important safety questions. MSCs can divide, interact with the immune system, and circulate through the bloodstream. Because of these properties, scientists carefully monitor potential risks that could limit clinical use.
Early clinical trials suggested MSCs were generally safe, but these studies were small. As more trials were completed and patient numbers increased, researchers recognized the need to systematically review the evidence to identify any consistent safety signals that might not be obvious in individual studies.
Methods Used to Evaluate MSC Safety
To answer this question, researchers conducted a comprehensive systematic review and meta-analysis of randomized controlled trials. These trials compared patients who received MSC therapy via the bloodstream with those who received standard care or a placebo.
The review included studies published between 2012 and 2019 and built on an earlier 2012 review. The authors searched major medical databases and screened nearly 7,500 scientific papers. After careful evaluation, 55 randomized controlled trials involving 2,696 adult patients met the inclusion criteria.
By pooling data from multiple trials and using rigorous statistical methods, the researchers were able to estimate whether MSC therapy increased the risk of any negative events compared to control treatments.
Incidence of Fever Following MSC Therapy
Across all included trials, fever was the only adverse event that occurred more frequently in patients receiving MSC therapy compared to controls. Patients treated with MSCs were about 2.5 times more likely to develop a fever.
Notably, most of these fevers were mild and temporary. Although some fevers were reported as serious adverse events, they were rare overall. Fever typically occurred shortly after infusion and resolved without long-term consequences.
This finding is consistent with earlier reviews and is thought to reflect the body’s immune response to the infused cells rather than a sign of lasting harm. Recognizing fever as a known and manageable side effect helps clinicians monitor patients appropriately during and after treatment.
No Increased Risk of Infection, Thrombosis, or Malignancy
Beyond fever, the review found no significant increase in other major safety concerns. Patients receiving MSC therapy did not experience higher infection rates than controls, despite the cells’ immune-modulating effects. This suggests that MSCs do not meaningfully weaken immune defenses in clinical settings.
The analysis also found no association between MSC therapy and thrombotic or embolic events. Blood clots were rare overall and occurred at similar rates in both MSC-treated patients and control groups. This is particularly reassuring given ongoing research into how MSCs may interact with clotting pathways.
Perhaps most importantly, the review found no increased risk of malignancy. MSC-treated patients did not develop cancer more frequently than those in control groups. This finding addresses a longstanding concern related to the cells’ ability to proliferate and supports their continued investigation in clinical medicine.
Observed Reduction in Mortality
One of the more notable findings from this review was a reduced risk of death in patients receiving MSC therapy compared to controls. While this review was focused on safety rather than effectiveness, this observation suggests that MSC therapy does not increase mortality risk and may even offer protective benefits in specific patient populations.
It is important to interpret this finding cautiously, as the trials involved varied conditions and were not designed to measure survival as a primary outcome. Still, the absence of increased mortality provides further reassurance regarding safety.
Improved Safety Monitoring in Recent Trials
Compared to earlier studies, recent MSC clinical trials demonstrated improved attention to safety monitoring. More than three-quarters of the included trials reported having a predefined plan to track adverse events, a substantial improvement over earlier research.
Notably, none of the trials were stopped early due to safety concerns. Serious adverse events that were judged to be related or possibly related to treatment were extremely rare, occurring in only a small fraction of patients across all studies.
This progress reflects a maturing field that recognizes the importance of transparency, standardized reporting, and rigorous trial design.
Challenges in Trial Design and Reporting
Despite these encouraging findings, the authors highlighted areas that still need improvement. Only a small number of trials met all criteria for low risk of bias, indicating that study design quality varies widely across the field.
Reporting of MSC characteristics was another area of concern. Only a minority of trials fully described how MSCs were defined, tested for viability, or assessed for biological potency. These details are critical for understanding why some trials succeed while others do not.
Without consistent reporting standards, it becomes harder to compare results across studies or identify factors that influence outcomes. Improving transparency in cell characterization will be essential as newer, second-generation MSC products move into clinical trials.
Implications for Patients and Families
For patients considering participation in MSC clinical trials or learning about regenerative medicine options, this large body of evidence offers important reassurance. Across thousands of patients and dozens of trials, MSC therapy has consistently shown a strong safety record.
The most common side effect, fever, is generally temporary and manageable. Serious concerns such as infection, blood clots, cancer, and death have not been linked to MSC therapy when compared to standard treatments.
As with any investigational therapy, participation in clinical trials should involve careful discussion with healthcare providers, but concerns about safety alone should not be a barrier, given the current evidence.
Future Directions in MSC Research
MSC research continues to evolve as researchers learn more about how these cells work, how they interact with the immune and clotting systems, and how manufacturing methods influence their behavior. Future trials will explore new indications, refined dosing strategies, and enhanced cell products designed to improve consistency and effectiveness.
Ongoing safety monitoring remains essential, particularly as therapies move into larger and more diverse patient populations. Continued adherence to rigorous trial design and transparent reporting will help ensure that advances in regenerative medicine are both effective and safe.
Overall Conclusions on MSC Safety
Thompson et al.’s updated review provides the most comprehensive evaluation to date of the safety of mesenchymal stromal cell therapy in adult clinical trials. Aside from an increased likelihood of fever, no meaningful safety signals were identified across thousands of patients.
The findings reinforce the conclusion that MSC therapy continues to demonstrate a favorable safety profile. For researchers, clinicians, regulators, and patients alike, this growing body of evidence supports the responsible, ongoing development of MSC-based therapies as part of the evolving field of regenerative medicine.
As research progresses, maintaining high standards for study design, cell characterization, and adverse event reporting will be key to translating this promising therapy into broader clinical practice.
Source: Thompson M, Mei SHJ, Wolfe D, Champagne J, Fergusson D, Stewart DJ, Sullivan KJ, Doxtator E, Lalu M, English SW, Granton J, Hutton B, Marshall J, Maybee A, Walley KR, Santos CD, Winston B, McIntyre L. Cell therapy with intravascular administration of mesenchymal stromal cells continues to appear safe: An updated systematic review and meta-analysis. EClinicalMedicine. 2020 Jan 17;19:100249. doi: 10.1016/j.eclinm.2019.100249. PMID: 31989101; PMCID: PMC6970160.
Mesenchymal stromal stem cells, commonly called MSCs, have been among the most-studied cell types in regenerative medicine over the past two decades. They have been tested in hundreds of clinical trials for conditions ranging from joint degeneration to heart disease, autoimmune disorders, lung injury, and complications after transplantation.
MSCs have consistently been shown to be safe, but their effectiveness has been mixed. Many trials have not met their main efficacy goals, and only a small number of MSC-based products have received regulatory approval worldwide.
This review by Lu and Allickson examines what has been discovered about MSC therapy and what remains to be done before these therapies can be widely adopted in routine clinical practice.
From Bone Marrow Cells to Powerful Immune Modulators
MSCs were first identified in mouse bone marrow as cells that could support blood-forming stem cells and form bone, cartilage, and fat. Human MSCs were later isolated in the 1990s. Early on, much of the excitement around MSCs focused on their ability to turn into different mesodermal tissues and directly replace damaged cells.
However, over time, it became clear that this “replacement” model did not fully explain what was happening in living organisms. In patients, MSCs do not routinely transform into large amounts of new tissue. Instead, their main therapeutic effects appear to come from the signals they send out rather than the cells they become.
Today, most researchers view MSCs as “medicinal signaling cells.” They can self-renew and still form bone, cartilage, and muscle, but their real power lies in their paracrine effects. MSCs sense damage and inflammation in their environment and respond by releasing a complex mix of biologically active molecules. This includes cytokines, chemokines, growth factors, extracellular matrix components, and extracellular vesicles that carry proteins, lipids, and genetic material, such as microRNAs. These signals help guide other cells to repair tissue, grow new blood vessels, calm harmful immune responses, and limit scarring.
How MSCs Influence Repair and Immunity
MSCs have been shown in laboratory and animal studies to home to sites of injury and support tissue repair in the heart, lungs, joints, nervous system, and other organs. They create a local microenvironment that encourages healing, reduces cell death, and can improve organ function after injury.
Equally important is their role in immune modulation. MSC-derived factors can shift the immune system away from a highly inflammatory state and toward a more balanced, regulatory profile. They interact with many types of immune cells, including T cells, B cells, macrophages, dendritic cells, and natural killer cells, and can either dampen or support immune activity depending on the context. This flexible, environment-dependent behavior is one of the reasons MSCs are being studied for such a wide range of inflammatory and immune-mediated conditions.
Extracellular vesicles released by MSCs, also known as MSC-derived EVs, are a significant contributor to their effectiveness. These tiny membrane-bound packages carry proteins, RNAs, and other molecules that can travel to distant cells and influence their behavior. EVs from MSCs have shown the ability to reduce fibrosis, promote tissue regeneration, and calm inflammation in preclinical models, raising interest in EVs as a possible “cell-free” therapy that might someday complement or even replace live cell treatments.
Defining an MSC: Why Standards Matter
One ongoing challenge in MSC research is that not all MSCs are the same. They can be derived from many different tissues, including bone marrow, adipose tissue, and perinatal tissues such as the placenta and the umbilical cord. Each source can produce cells with different characteristics, and even cells from the same source can vary based on how they are collected, cultured, and stored.
To create consistency in the field, the International Society for Cellular Therapy established basic criteria in 2006 to define human MSCs. According to these guidelines, MSCs must adhere to plastic in standard lab cultures, express specific surface markers, and differentiate into bone, cartilage, and fat cells under appropriate laboratory conditions.
Even with these guidelines, the authors note that there remains considerable variability across MSC products. Differences in cell source, donor characteristics, manufacturing methods, dosing strategies, and delivery routes all contribute to the wide range of outcomes seen in clinical trials. This variability is one of the main reasons it has been difficult to draw simple conclusions about “MSC therapy” as a single, uniform treatment.
Regulatory Approvals: A Few Successes Among Many Trials
Despite the large number of registered MSC trials worldwide, only a limited number of MSC-based products have received regulatory approval so far. Different countries regulate cell therapies through agencies similar to the U.S. Food and Drug Administration, such as Health Canada, the European Medicines Agency, and others in Asia.
One important milestone highlighted in this review is the recent approval in the United States of an MSC therapy for pediatric graft-versus-host disease, a serious complication of stem cell transplantation. This marks the first MSC therapy approved by the FDA and demonstrates that, under the right conditions, MSCs can meet the rigorous safety, quality, and benefit standards required by regulators.
Outside the U.S., several other MSC-based products have been approved for conditions such as cartilage defects and graft-versus-host disease. However, when viewed against the backdrop of hundreds of trials, the number of approvals remains small, emphasizing how challenging it has been to translate the promise of MSCs into consistent, reproducible clinical benefit.
What the Clinical Trial Landscape Looks Like
A recent search of the ClinicalTrials.gov database found hundreds of registered studies involving mesenchymal stromal or mesenchymal stem cells, covering early-phase safety trials through more advanced phase 3 and 4 studies. These trials span a wide range of indications, from orthopedic and cardiovascular disorders to autoimmune diseases, neurological conditions, and complications of cancer treatment.
Yet, a key concern is that the vast majority of these trials have not reported their results publicly. This lack of accessible outcome data makes it difficult for clinicians and researchers to fully understand where MSCs are working well, where they are not, and what factors may explain the differences. It also slows progress in refining protocols and designing better future studies.
Safety: A Clear Strength of MSC Therapy
One consistent and reassuring theme across the MSC literature is safety. Clinical trials over more than two decades have shown that MSC therapy is generally very well tolerated. Reports of serious infusion reactions, organ damage, severe infections, cancers, or treatment-related deaths directly attributable to MSCs have been extremely rare.
Safety data is especially strong for bone marrow–derived and adipose-derived MSCs, which have the longest track record in human studies. Newer sources, including perinatal tissues, also appear promising but may benefit from longer follow-up and more comprehensive monitoring as experience grows.
The Efficacy Challenge and Future Directions
While safety has been firmly established, efficacy has been much less consistent. Many MSC trials have failed to meet their primary endpoints, and in some cases, the benefits have been modest or difficult to distinguish from placebo or standard care. This is not unique to MSCs—many new therapies face similar hurdles—but it does mean that expectations must be realistic.
Lu and Allickson emphasize that the next chapter for MSC therapy will depend on solving several key problems. These include better defining which patients and diseases are most likely to respond, standardizing and optimizing cell manufacturing, clarifying dose and timing, and understanding how factors like age, comorbidities, and prior treatments influence outcomes. It will also be important to determine when MSCs should be used alone and when they may be most effective in combination with other therapies.
What This Means for Patients Today
The data shows that MSCs are safe with clear potential for tissue repair and immune modulation. At the same time, the field is still working to consistently translate these biological effects into strong, repeatable clinical benefits across many diseases.
As research continues, mesenchymal stromal cell therapy remains one of the most carefully studied and promising avenues in regenerative medicine. The progress to date provides a strong foundation, and the future outlook will depend on rigorous science, thoughtful trial design, and continued collaboration between researchers, clinicians, regulators, and patients.
If you or someone you care about has been diagnosed with a spinal cord injury, you understand how life-altering the challenges can be. At Stemedix, we work with patients who have already received a confirmed diagnosis and are seeking alternative ways to support their recovery goals. While no treatment guarantees a cure, regenerative medicine offers the potential to support healing and reduce the impact of symptoms through biologically active therapies.
Stem cell therapy for spinal cord injury is one such approach that may help promote cellular repair, reduce inflammation, and encourage nerve support. You won’t find exaggerated claims or comparisons here, just realistic, patient-focused information backed by experience. We customize each treatment plan using the documentation you provide, and we support you throughout your journey. This article will walk you through the basics of spinal cord injury, explain how stem cells for the treatment of spinal cord injury are used, and outline what to expect with our process.
What is Spinal Cord Injury?
A spinal cord injury (SCI) is damage to the spinal cord that disrupts communication between the brain and the body. When this pathway is damaged, the body’s ability to send and receive signals becomes impaired. That can mean a loss of movement, sensation, or automatic functions like bladder and bowel control. Most spinal cord injuries happen because of sudden trauma. Studies show that the most common causes of SCI were automobile crashes (31.5%) and falls (25.3%), followed by gunshot wounds (10.4%), motorcycle crashes (6.8%), diving incidents (4.7%), and medical/surgical complications (4.3%).
The spinal cord does not regenerate the way some tissues in the body do. This makes the injury permanent in many cases. The outcome depends on where the injury occurred and how much of the nerve pathway is still intact.
Types and Locations of Spinal Cord Injuries
Spinal cord injury (SCI) is classified by severity, complete or incomplete, and by the spinal region affected. A complete injury results in loss of all movement and sensation below the injury site, while incomplete injuries allow some function. The spinal region involved guides recovery and therapy goals.
Cervical nerve injuries (C1–C8) impact the neck, arms, hands, and breathing, with higher levels possibly requiring ventilation support. Thoracic injuries (T1–T12) affect chest and abdominal muscles, impacting balance and trunk control. Lumbar and sacral injuries (L1–S5) influence leg movement and bladder function, with outcomes varying based on injury extent and completeness.
Common Symptoms and Challenges After SCI
Patients with SCI may experience paralysis, sensory loss, chronic pain, and complications in daily functions. Spinal cord injury affects more than movement. Many patients deal with muscle spasticity, pressure injuries due to immobility, frequent urinary tract infections, and problems with body temperature control. Autonomic dysreflexia, a sudden increase in blood pressure triggered by stimuli below the injury level, is a serious risk in those with injuries at or above T6. Emotional and psychological responses, including anxiety and depression, are also common and require support.
At Stemedix, we recognize that each spinal cord injury is unique. We tailor every treatment plan based on the medical records and information you provide, not generalized assumptions. If you’re exploring stem cells for the treatment of spinal cord injury, our team is ready to walk you through options that align with your health history and functional goals.
What is Regenerative Medicine?
Regenerative medicine supports the body’s repair mechanisms by introducing biologically active materials. This field focuses on helping your body respond to damage by using living cells and biological components. Instead of masking symptoms, regenerative treatments aim to influence the cellular environment that surrounds the injured tissue. In many cases, this includes the use of stem cells and growth factors.
For individuals with a spinal cord injury, regenerative medicine introduces new options that may encourage healing responses the body struggles to activate on its own. While this type of therapy doesn’t replace rehabilitation, it may work alongside your current efforts to promote tissue stability and reduce secondary complications.
Stem Cell Therapy as a Treatment Option for SCI
Stem cell therapy for spinal cord injury is being explored to support recovery and symptom relief. Researchers are investigating how stem cells may influence the biological environment of an injured spinal cord. You won’t find a generalized approach here. Stem cell treatment for spinal cord injury is tailored to each case based on the location of injury, severity, and medical history.
The focus is not on reversing the damage or offering a cure. Instead, stem cells for the treatment of spinal cord injury may help by releasing chemical signals that support the health of nearby nerve cells, protect against further breakdown, and potentially stimulate limited repair processes. Some patients have reported improvements in muscle control, sensation, or bladder regulation, though outcomes vary and remain under study.
How Stem Cells Work to Support Healing
Stem cells can develop into specialized cell types and secrete proteins that support tissue repair. These cells have two key roles in regenerative medicine. First, they can adapt to different cell types, such as those found in the nervous system. Second, and equally important, they release helpful proteins, like cytokines and growth factors, that create a healing-friendly environment. This may reduce chronic inflammation and improve communication between nerve cells that remain intact.
In spinal cord injury cases, these cells may influence glial scar formation, improve blood flow to the damaged region, and protect vulnerable cells from oxidative stress. For example, studies have shown that transplanted mesenchymal stem cells can release brain-derived neurotrophic factor (BDNF), which plays a role in supporting neural survival.
At Stemedix, we offer regenerative therapy based on the existing diagnosis and medical documentation provided by each patient. Our approach respects the experimental nature of this therapy while offering guidance and structure throughout the process.
Potential Benefits of Stem Cell Therapy for Spinal Cord Injury
Exploring the potential benefits of stem cell therapy gives you a chance to learn how regenerative medicine may support certain aspects of your spinal cord injury recovery. While results vary for each individual, many patients report improvements in pain, movement, and physical function over time.
Pain Reduction and Muscle Relaxation
Many patients report decreased neuropathic pain and reduced muscle tension following therapy. Neuropathic pain is one of the most common and challenging symptoms following spinal cord injury. You may experience burning, tingling, or shooting sensations due to misfiring nerves. For some individuals receiving stem cell therapy for spinal cord injury, these symptoms become less intense or more manageable. This could be related to how certain types of stem cells interact with immune cells and inflammatory pathways.
Studies have suggested that mesenchymal stem cells (MSCs), for example, can release bioactive molecules that influence the environment surrounding injured nerves and even interact with neural cells in spine and brain conditions. In some cases, patients also describe less spasticity or tightness in the muscles, which can reduce discomfort during sleep or daily movement.
Improved Circulation and Motor Function
Stem cell treatment for spinal cord injury may support vascular health and contribute to smoother movement. Reduced blood flow after a spinal cord injury can limit your body’s ability to heal or respond to therapy. You might notice cold extremities, swelling, or slower wound healing. Stem cell therapy may support microvascular repair by promoting angiogenesis, the formation of new blood vessels in damaged tissues. This improved circulation helps deliver oxygen and nutrients more efficiently to the affected areas. Some individuals receiving stem cell therapy report smoother joint movement, greater control over posture, and better balance during transfer or mobility tasks.
Increased Muscle Strength and Abilities
Muscle engagement and strength may increase as nerve signals improve. After a spinal cord injury, the connection between your brain and muscles may be disrupted or weakened. Over time, this can lead to muscle wasting or limited control. For individuals receiving stem cell treatment for spinal cord injury, some report noticeable changes in muscle tone, voluntary movement, or strength, especially in the lower limbs or core. These observations tend to occur in cases where some nerve pathways remain intact.
For example, a patient with an incomplete thoracic injury might regain the ability to perform assisted standing exercises or show improvements in hip stability. While not every case leads to increased muscle output, any gains in strength can contribute to mobility training, sitting tolerance, and daily activities.
Patient Experience and Reported Outcomes
Individuals receiving therapy frequently describe improvements in mobility, energy levels, and daily activity. Each patient arrives with unique goals. Some hope to walk again. Others want to reduce fatigue or rely less on medications. After therapy, individuals often share changes that impact their quality of life, such as being able to transfer with less assistance, participate in treatment longer, or sleep more comfortably.
At Stemedix, we focus on your specific history, symptoms, and expectations before building a treatment plan. These outcomes help us communicate realistic possibilities, while always making it clear that regenerative medicine is still considered experimental.
How Stemedix Approaches Stem Cell Therapy for SCI
Every individual with a spinal cord injury has a different medical background and a different journey. That’s why your treatment experience with Stemedix begins with your history, not just your condition.
Customized Treatment Based on Patient History
Stemedix develops treatment plans based on medical records submitted by the patient. If you’ve already received a spinal cord injury diagnosis, our team starts by reviewing the medical documents you send us. This includes imaging studies, physician assessments, and any other relevant details about your injury. By focusing on those who have already completed a diagnostic evaluation, we’re able to provide a more appropriate regenerative therapy experience.
We do not perform physical exams or order MRIs. If your current records are outdated, we can help gather updated information on your behalf once you sign a simple medical release form. This makes sure that our team has the most accurate data to tailor a regenerative approach based on your unique condition, designing therapy around what your body truly needs, not generalized assumptions.
Role of Board-Certified Physicians and Care Coordinators
Each case is reviewed by board-certified physicians experienced in regenerative medicine. When you choose to move forward, your medical information is assessed by physicians who specialize in regenerative therapies. They have experience working with spinal cord injury patients and understand how stem cell therapy may support certain biological functions involved in healing.
Patients are supported by dedicated Care Coordinators who handle logistics, scheduling, and communication. You won’t be left navigating the details alone. Once your evaluation is underway, a Care Coordinator will work closely with you to keep the process on track. This includes walking you through the next steps, answering questions, and helping schedule your treatment. Having one point of contact makes the entire journey easier to follow and less overwhelming.
Patient Support Services and Accommodations
Stemedix offers assistance with travel arrangements, transportation, and medical support equipment. Whether you’re located nearby or traveling across the country, we help remove logistical barriers. Our team can coordinate hotel stays, provide complimentary ground transportation, and arrange for wheelchair-accessible options if needed.
Whether a patient is local or traveling from another state, Stemedix helps coordinate hotels and driver services to make the process more accessible. Your focus should be on preparing for therapy, not stressing over logistics.
Getting Started with Stemedix
How to Connect with a Care Coordinator
Our Care Coordinators are ready to assist you at every step. They can answer your questions, review your medical documents, and guide you through the application process. From your initial inquiry through follow-up care, they provide consistent support to help you understand the next steps in pursuing stem cell therapy for spinal cord injury.
What to Expect During the Treatment Process
Once your case is reviewed and approved by our physicians, you will receive a customized treatment plan with a scheduled date for your therapy. Treatment is provided in a licensed medical facility under the supervision of experienced professionals. After treatment, ongoing follow-up is available to monitor your progress and provide additional support as needed.
Contact Stemedix Today
If you are interested in learning more about stem cell treatment for spinal cord injury, request an information packet today. The team at Stemedix is here to guide you on your journey to better health. Call us at (727) 456-8968 or email yourjourney@stemedix.com to know more.
This website and its contents are not intended to treat, cure, diagnose, or prevent any disease. Stemedix, Inc. shall not be held liable for the medical claims made by patient testimonials or videos. They are not to be viewed as a guarantee for each individual. The efficacy for some products presented have not been confirmed by the Food and Drug Administration (FDA).
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