Intrathecal cell delivery has emerged as a promising approach for improving the quality of life for patients with neurological conditions, thanks to previous studies showing its safety and potential benefits.
As part of this review, Mesa Bedoya et al. summarize the findings of a systematic review and meta-analysis aimed at evaluating the safety of intrathecally delivered mesenchymal stem cells (MSCs).
Neurological disorders, such as Alzheimer’s disease, Parkinson’s disease, and multiple sclerosis, significantly impact patients’ quality of life and contribute to a substantial global disease burden. With limited treatment options available, MSC therapy has gained attention due to its ability to differentiate into various cell types, secrete growth factors, and provide neuroprotection. MSCs can be delivered through several routes, including intrathecal administration, which allows for direct delivery to the central nervous system (CNS) and has been shown to enhance cell bioavailability near damaged areas.
The authors’ primary goal was to assess the safety of intrathecal MSC administration by analyzing randomized controlled trials (RCTs) comparing this method to control treatments in adult patients with neurological conditions.
As part of this review, Mesa Bedoya et al. conducted a thorough search of several databases up through April 2023, including RCTs that compared intrathecal MSC delivery with control treatments. They focused on adverse events (AEs) and performed a meta-analysis using statistical models to evaluate the overall safety. The authors also examined potential factors influencing the occurrence of AEs and assessed publication bias.
A total of 303 records were reviewed, with nine RCTs involving 540 patients meeting the inclusion criteria. The analysis revealed that intrathecal MSCs were associated with an increased probability of AEs related to musculoskeletal and connective tissue disorders. Specifically, fresh MSCs had a higher probability of causing AEs compared to cryopreserved MSCs. Additionally, multiple doses of MSCs were associated with a 36% reduction in the probability of AEs compared to single doses.
Despite these findings, the data did not show significant associations between AEs and various study covariates. The review highlighted that, while there was a higher incidence of musculoskeletal and connective tissue disorders, no serious adverse events (SAEs) were reported. The most common AEs, which included back pain, pain in extremities, and muscle aches, were generally transient and minimal in risk if patients were monitored appropriately.
Mesa Bedoya et al’s study supports the notion that intrathecal MSC delivery is a generally safe procedure, with an increased risk of specific, minor AEs. It also confirms previous findings that suggest this method is a viable option for delivering MSC therapy to patients with neurological conditions.
However, the authors also acknowledge limitations, including potential small-study effects and issues related to the crossover design of some included trials. These limitations suggest that the results should be interpreted with caution, and the findings highlight the need for larger, well-designed RCTs with longer follow-up periods to validate the safety and efficacy of intrathecal MSC delivery.
The authors conclude that this review indicates that intrathecal delivery of MSCs results in a minor increase in AEs related to musculoskeletal and connective tissue disorders but no serious adverse events. This supports the safety of intrathecal MSC therapy for neurological conditions, though further research with larger sample sizes and more rigorous study designs is needed to confirm these findings and address the limitations identified.
Source: Mesa Bedoya, L.E., Camacho Barbosa, J.C., López Quiceno, L. et al. The safety profile of mesenchymal stem cell therapy administered through intrathecal injections for treating neurological disorders: a systematic review and meta-analysis of randomised controlled trials. Stem Cell Res Ther 15, 146 (2024). https://doi.org/10.1186/s13287-024-03748-7
Liver cirrhosis (LC) is a severe global health problem, contributing to an estimated two million deaths annually. LC results from chronic liver diseases such as hepatitis B and C, alcohol consumption, non-alcoholic fatty liver disease, and autoimmune liver disease. When these diseases progress unchecked, they lead to liver cirrhosis, characterized by inflammation and fibrosis. Most patients with LC die from complications due to a lack of effective treatments and poor patient compliance. While liver transplantation is effective, it is costly and comes with risks like immune rejection and recurrent infections. This has led to an urgent need for alternative treatments for LC.
Mesenchymal stem cells (MSCs) offer a promising alternative due to their ability to renew themselves and differentiate into various cell types. MSCs have gained attention for their potential to treat tissue-damaging diseases due to their low immunogenicity and ability to home to injury sites. Animal studies have shown MSCs to be safe and effective in treating LC, and clinical trials indicate improvements in liver function with no significant adverse effects.
Lu et al.’s study aims to systematically evaluate the efficacy and safety of MSCs for treating liver cirrhosis through a meta-analysis of clinical trials.
As part of this study, the authors analyzed data from PubMed/Medline, Web of Science, EMBASE, and Cochrane Library up through May 2023. Researchers used the PICOS principle for literature screening and assessed the risk of bias. Data from each study’s outcome indicators, such as liver function and adverse events, were then extracted and analyzed using Review Manager 5.4.
Eleven clinical trials met the criteria for this analysis. The pooled data showed significant improvements in primary and secondary liver function indicators. Patients who received MSC infusions had higher albumin (ALB) levels at 2 weeks, 1 month, 3 months, and 6 months, and lower MELD scores at 1 month, 2 months, and 6 months compared to the control group. Hepatic arterial injections were particularly effective in improving these scores. Importantly, none of the studies reported severe adverse effects, indicating the safety of MSC therapy.
Key Findings and Recommendations
Considering the findings of this study, the authors provide a number of key findings and recommendations, including:
Duration of MSC Therapy: The study found that prolonging MSC treatment enhances its effectiveness in end-stage liver disease, improving symptoms such as appetite loss, mental depression, and jaundice.
Types of MSCs: MSCs can be derived from various tissues, and their effectiveness may vary. Most studies evaluated used bone marrow-derived MSCs (BM-MSCs), which have shown superior therapeutic effects compared to umbilical cord-derived MSCs (UC-MSCs). However, more research is needed to determine the best type of MSC for treating LC.
Routes of Administration: Different transplantation methods can impact the efficacy of MSC therapy. The hepatic artery route was found to be the most effective, likely due to better MSC homing to the liver. However, this method has clinical limitations such as high surgical risk. Intravenous administration, while safer, was less effective. The authors call for further research to optimize the administration route.
Secondary Indicators: While primary indicators like MELD score and ALB levels showed significant improvements, secondary indicators such as ALT, AST, TBIL, and INR did not show significant differences between the MSC and control groups. The authors believe this could be due to variability in disease cause, patient population, and follow-up duration.
Complications and Prognosis: MSC therapy also showed potential in reducing LC complications, such as portal hypertension and ascites, and decreasing mortality and hepatocellular carcinoma (HCC) incidence. However, more clinical trials are needed to confirm these findings and assess the long-term prognosis of MSC therapy in LC.
Lu et al. conclude that mesenchymal stem cell therapy is a safe and effective treatment for liver cirrhosis, significantly improving liver function without severe adverse effects. However, to fully realize the potential of MSC therapy, a standardized treatment protocol is needed. This includes optimizing the timing, dosage, frequency, and administration route of MSC infusions.
Additionally, MSC-derived exosomes show promise as an alternative treatment strategy. The authors call for further research, including multicenter, large-scale, long-term RCTs, to address these questions and improve the therapeutic outcomes for LC patients.
Amyotrophic Lateral Sclerosis (ALS) is a degenerative disease that affects motor neurons in the brain and spinal cord, leading to muscle paralysis and death, typically within 3-5 years of onset. Despite two FDA-approved therapies, Riluzole, and Edravarone, which offer limited benefits, there remains no cure for ALS.
Considering this, researchers have turned to Mesenchymal Stem Cells (MSCs), which have shown promise in animal models and preliminary human trials for neurodegenerative diseases, including ALS.
Understanding ALS and MSC Therapy
ALS is characterized by the rapid degeneration of motor neurons, leading to muscle paralysis. The exact cause of ALS is complex and not fully understood. About 10% of cases are familial, while 90% are sporadic. Existing treatments only modestly slow disease progression and extend survival by a few months.
Stem cells, particularly MSCs, have shown potential in neuroprotection and immunomodulation. MSCs can be derived from various sources, including bone marrow, adipose tissue, embryonic tissue, cord blood, reprogrammed mature cells, and perinatal tissue. They support hematopoiesis and produce mesodermal cells. MSCs have demonstrated immunomodulatory and neurotrophic effects in animal models and early human trials.
As part of this study, Petrou et al. aimed to evaluate the safety and efficacy of repeated spinal injections of autologous MSCs in ALS patients. This open-label clinical trial included patients aged 20-70, with definite ALS diagnoses and ALS Functional Rating Scale Revised (ALSFRS-R) scores above 20. The patients received 1-4 intrathecal MSC injections at intervals of 3-6 months, with safety and tolerability as primary endpoints, and efficacy as secondary endpoints.
This trial found no serious adverse events, demonstrating the safety of repeated MSC injections. As evidence, the authors point out that, 15 out of 19 patients showed a reduction in the progression rate of their ALSFRS-R scores by more than 25% between the first and second injections, with an average improvement of 107.1%. Similar improvements were observed between subsequent injections. Thirteen patients experienced a 25% improvement in their progression rate over the entire treatment period, with an average improvement of 47.4%. Seven patients showed clinical improvement after the first transplantation, and five remained improved after the second cycle. These benefits were correlated with the intervals between the injections, suggesting that regular MSC administrations might be crucial for sustained efficacy.
Previous Studies on MSCs in ALS
Several small, open-label clinical trials have suggested that MSC treatment can be beneficial for neurological diseases, including ALS. In a phase I/II trial by the same research group, ALS patients received intrathecal and intravenous MSC injections, which were safe and showed a trend toward disease stabilization over six months. Another phase I/II and IIa trial with Brainstorm® used modified MSCs producing neurotrophic factors (MSC-NTF), showing at least a 25% improvement in disease progression, particularly in the intrathecally treated group.
Additional trials, including a randomized, placebo-controlled phase II study, demonstrated mixed results. While some trials noted improvements in a subgroup of rapid progressors, others did not show significant differences between MSC-treated and placebo groups overall. These studies highlight the need for repeated injections to maintain the benefits of MSC therapy.
Implications From the Current Study
According to Petrou et al., repeated intrathecal injections of MSCs over a longer follow-up period appears to induce significant, but short-term, clinical improvements and slow disease progression in a majority of patients. This study also reaffirmed the safety profile of MSC, with only mild and transient adverse events observed.
The study highlights the potential of MSC therapy in providing neuroprotection and slowing ALS progression. The immunomodulatory effects of MSCs, possibly reducing inflammation in the central nervous system, may also contribute to their therapeutic benefits. However, the small sample size and open-label design are limitations, necessitating larger, controlled trials to confirm these findings.
Future Directions
Petrou et al. concluded that repeated intrathecal injections of autologous MSCs are safe for ALS patients and suggest potential medium-term clinical benefits. However, larger studies are needed to confirm these findings. The consistent observation of safety and indications of efficacy across multiple cycles of treatment is encouraging, indicating that MSC therapy could slow the progression of ALS and improve patients’ quality of life.
The study’s promising results support the continued exploration of MSC therapy for ALS. The authors call for future trials to focus on optimizing the timing and frequency of MSC injections to maximize clinical benefits. Larger, controlled studies are essential to validate these findings and potentially establish MSC therapy as a viable treatment option for ALS. By addressing the unmet needs in neuroprotection and immunomodulation, MSC therapy holds the potential of improving the quality of life and survival for ALS patients.
Source: Panayiota Petrou, Ibrahim Kassis, Nour Eddine Yaghmour, Ariel Ginzberg, Dimitrios Karussis. A phase II clinical trial with repeated intrathecal injections of autologous mesenchymal stem cells in patients with amyotrophic lateral sclerosis. Front. Biosci. (Landmark Ed)2021, 26(10), 693–706. https://doi.org/10.52586/4980
You might think of kidney health problems as separate issues from your blood pressure. However, renal hypertension, a form of high blood pressure, can be just as serious as cardiovascular health conditions.
It’s important to understand the link between kidney function and blood pressure. Once your kidneys become compromised, the damage isn’t reversible. Know the signs, symptoms, and treatment options related to renal hypertension so you can maintain your kidney health as long as possible.
How Renal Hypertension Develops
Your kidneys work with the rest of your body to maintain your blood pressure, fluid and sodium balance, pH levels, and more. When either your kidneys or the rest of your body is thrown out of balance, the other can suffer.
Narrowed Kidney Arteries
Renal hypertension has the same cause as standard high blood pressure — the narrowing of arteries. With this disease, the arteries that are most compromised are the ones that lead into your kidneys. This can be very dangerous if left untreated.
Many different factors can cause narrowed kidney arteries, including atherosclerosis (plaque buildup), scarring due to general hypertension, and others. When this happens, you’re at an increased risk of developing renal hypertension.
Your Kidneys’ Response
When your kidneys aren’t getting enough blood flow — which is a common issue when your arteries narrow — they release certain hormones. These hormones cause your blood pressure to rise in an attempt to get more blood flowing to your kidneys.
The Vicious Cycle of Renal Hypertension
Renal hypertension is a real problem, particularly if it progresses for a long time. Once your kidney blood flow is compromised, your kidneys stop working as efficiently.
One of the primary functions of your kidneys is to balance sodium and water levels in your body. Compromised kidneys won’t filter sodium out of your system as effectively. When there’s too much sodium circulating, you experience high blood pressure, and the hypertension cycle continues.
Chronic hypertension can contribute to the development of kidney disease, which has no cure. Many experts consider kidney disease to be the root cause of renal hypertension, but general hypertension plays a large role as well.
Common Signs and Symptoms of Renal Hypertension
You might be wondering if this problem will affect you, especially if you’ve already been diagnosed with general hypertension. There are key signs and symptoms to look out for. You should also consult closely with a physician who can monitor your blood and kidney health consistently.
Headaches
In some cases, high blood pressure will cause headaches or migraines. Scientists believe this happens because of changes in the blood-brain barrier. Pressure can build in this region during high blood pressure episodes, leading to discomfort, pain, and migraine headache symptoms.
Vision Changes
Extremely high blood pressure levels can damage the arteries and blood vessels in your eyes. This leads to double vision, blurriness, and general difficulty seeing. If you experience sudden changes in your vision, renal hypertension may be the culprit.
Confusion
Your brain can’t function properly when your blood pressure is too high. This symptom is usually a sign that you’re in a hypertensive crisis and need immediate medical attention. If you start feeling confused, dazed, or mentally foggy, consider renal hypertension as the root cause.
Nausea and Vomiting
Hypertensive crises usually induce nausea and, in some cases, bouts of vomiting. This is another critical symptom to watch for, as it means you need emergency medical treatment.
An Important Note
Renal hypertension, much like general hypertension, usually shows no symptoms. This is why it’s so dangerous, as patients may not know they have this condition until it’s too late. It’s essential to work with a specialist who can keep an eye on your blood pressure and kidney health if you have concerns.
It’s also important to note that kidney problems are mostly irreversible. While there are some promising treatments, like stem cell therapy for kidney disease, there is no known cure yet. Prevention is the key to managing your kidney health.
Potential Treatments for Better Kidney Health
Lifestyle changes and innovative treatments, namely regenerative medicine, may improve your kidney health over time. If your doctor has stated that you don’t need surgery to treat your renal hypertension, stem cell therapy may be right for you.
Lifestyle Changes to Lower Your Blood Pressure
Eating a diet low in sodium and free from added table salt can do wonders for your blood pressure levels. Your doctor may recommend that you make other lifestyle changes, like exercising daily and quitting smoking. These changes take time to get used to, but they can save your kidneys a lot of damage in the long run.
Blood Pressure Medication
This intervention is tricky because a key sign of renal hypertension is rising blood pressure that won’t respond to medication. However, in some cases, your doctor may be able to control your hypertension with a stronger blood pressure drug. This is usually the first line of treatment if you’re unable to make the necessary lifestyle changes.
Surgery
There are both minimally invasive and open surgical procedures for treating renal hypertension. Surgical interventions involve installing a balloon into the affected artery or using healthy tissue from a different artery to repair the damaged one. Either way, these interventions require a surgeon who specializes in these procedures.
Stem cells can be programmed to have anti-inflammatory properties, which reduces tissue damage throughout your body. When the affected area — in this case, your kidneys — receives stem cell therapy, damaged vessels and arteries might slowly heal and regenerate.
Regenerative medicine is drug-free and uses the natural healing properties of “blank” stem cells to assist in wound healing and tissue regeneration. Stem cell treatments may be a good option for treating your renal hypertension if you want to avoid surgery, medication, and other invasive interventions.
Renal Hypertension Prevention, Treatment, and Healing
You have options when it comes to preventing and treating your renal hypertension. Prevention is always the best way to avoid long-term complications. However, don’t be discouraged if the damage is already done. With the right information, you can make an informed decision on caring for your kidneys.
According to the World Health Organization, an estimated 422 million people worldwide have diabetes. Numerous studies have demonstrated that people with diabetes are at an increased risk of developing both acute and chronic pancreatitis, which increases the risk of developing pancreatic cancer.
Considering the lack of effective therapeutic options for pancreatitis and the limited treatment options for diabetes, researchers have recently turned to the potential of using mesenchymal stem cells (MSCs) as alternative therapeutic treatment options for these conditions.
In this review, Scuteri and Monfrini evaluate the different uses of MSCs for both the treatment of diabetes and the reduction of diabetes-related disease development.
According to the authors, MSCs offer several advantages, including the ability to be isolated from different tissues in a simple way, the ability to be easily harvested and expanded in vitro, and the absence of ethical problems associated with harvesting and use.
In addition, MSCs demonstrate the ability to differentiate, release soluble factors, and migrate toward lesions and sites of inflammation. Considering that inflammation and apoptosis are significant etiopathological factors of diabetes and pancreatitis, Scuteri and Monfrini indicate that MSCs are excellent candidates for regenerative medicine purposes.
In the case of MSCs and diabetes, research has demonstrated that differentiation of MSCs into insulin-releasing cells has been demonstrated in vitro after direct contact with pancreatic islets; the release of anti-inflammatory and antioxidant factors has improved the engraftment and prolonged the survival of transplanted pancreatic islets; and inhibited the apoptotic pathways triggered by endoplasmic reticulum stress in transplanted pancreatic islets. In analyzing this research, the authors conclude that the potential exists for the safe and effective use of MSCs for treatment of diabetes.
Although there has been growing interest in exploring the potential of MSCs on pancreatitis, there have only been a few studies exploring this therapeutic option. In these studies, the presence of MSCs was observed to reduce fibrosis and parenchymal damage by reducing proinflammatory factor expression.
In regard to MSCs and pancreatic cancer, since diabetes and pancreatitis are risk factors for the development of pancreatic cancer and considering MSCs have been found to hold potential as a therapeutic option for these diseases, using MSCs to interrupt the flow of factors leading to the development of pancreatic cancer should lower the incidence of diabetes-related pancreatic cancers.
The authors conclude that MSCs are a very promising therapeutic option for the treatment of diabetes, pancreatitis, and pancreatic cancer.
According to the Centers for Disease Control and Prevention, four million adults in the United States have fibromyalgia. It’s an often-misunderstood condition that leads to systemic joint and muscle pain, along with fatigue, making daily life very difficult. To deal with the pain the condition causes, it’s important to understand why it occurs. Learn more about fibromyalgia and your pain management options.
What Is Fibromyalgia? Symptoms and Causes
Fibromyalgia is a condition that leads to pain and tenderness all over the body. It’s a chronic condition, though symptoms tend to come and go. During flare-ups, the pain can be significant enough to interfere with daily life while also affecting sleep, leading to mental and physical distress.
During a flare-up, you can experience:
Fatigue
Pain
Headaches
Face and jaw pain
Bladder control issues
Digestive problems
Insomnia
It’s not clear what causes fibromyalgia, but scientists have found that certain conditions, as well as stress, can trigger it. You are also more likely to have this condition if you have a relative who suffers from it. Women are twice as likely as men to develop it.
People living with conditions like arthritis, depression, anxiety disorders, and irritable bowel syndrome are more likely to develop fibromyalgia.
Fibromyalgia can affect people of all ages, including children, but it’s more common in those who are middle-aged.
Diagnosing Fibromyalgia
If you’re experiencing symptoms, your doctor will likely perform a physical exam and discuss your medical history. There’s no test that can officially diagnose fibromyalgia, so your doctor will do what’s called a differential diagnosis — a kind of investigation that functions via a process of elimination.
Your doctor may order blood work to check hormone levels and look for signs of inflammation to help eliminate other diseases.
During the physical examination, your doctor will likely check for the presence or absence of tender spots by using light pressure.
Most of the time, if you have generalized pain that lasts for three months or more without any other underlying conditions, you’ll receive a diagnosis of fibromyalgia. The pain has to be spread throughout your body to get this diagnosis.
Treating Fibromyalgia: What You Can Expect
There isn’t one treatment that works for everyone. Usually, your doctor will try a number of different options, combining them to offer the most effective results.
Your provider will likely treat the condition depending on the symptoms you’re currently experiencing. There are stages of treatment, though these aren’t treatment plans that can be followed in order because the condition can affect you differently during every flare-up.
Exercise to Loosen Muscles
In some cases, turning to physical exercises, including stretching, can help loosen your muscles and ease some of the discomfort.
Low-impact exercises like walking and swimming help build flexibility that can improve your movement during flare-ups while simultaneously helping manage pain with the release of endorphins they stimulate. Exercise may also help you get better sleep.
Medications for Symptom Management
Over-the-counter medications can help manage pain, as can narcotics, though your doctor will prescribe these with care since they can lead to dependence.
Antidepressants can often also help the process, easing some of the fatigue and pain. For those who have trouble sleeping because of fibromyalgia, sleeping aids are often a good choice.
Heat and Cold Therapy for Milder Pain
In some cases, heat and cold therapy is also effective in managing some symptoms, especially if they’re mild. Alternating hot and cold packs helps the muscles release some of the tension that could be causing pain.
Occupational Therapy for Everyday Tasks
Turning to an occupational therapist is a great way of finding out how to restructure your life when you experience flare-ups. This type of therapist can help make adjustments to your work areas while also helping you find better ways of performing certain tasks so that you experience fewer symptoms.
Massage and Acupuncture to Improve Range of Motion
Massage therapy is a trusted technique. It relies on the manipulation of your muscles and soft tissues, increasing blood flow and improving range of motion while helping reduce pain. For many, it helps relieve stress, too, which can impact the severity of the symptoms.
Acupuncture is also helpful, with the needles affecting blood flow levels and even how certain neurotransmitters in the brain work.
Lifestyle Changes for Flare-Up Reduction
Making changes to your everyday life is an important way of helping minimize the symptoms of flare-ups, so try to incorporate some into your daily life. The right options can depend on your preferences. Some people turn to meditation, while others prefer to do breathing and mindfulness exercises.
The variety of treatments available include platelet-rich plasma therapy and stem cell therapy, which uses mesechymal stem cells to reduce inflammation and help calm the immune system. This makes it possible to better handle symptoms when you do have a flare-up.
Stem cell therapy is easy to combine with other treatment options and doesn’t require a long recovery period or the stress of dealing with side effects. Stem cell therapy and other regenerative medicine options help treat the underlying triggers like inflammation, so you’re not just covering symptoms with medications.
Living With Fibromyalgia
It can seem daunting to live with a chronic condition like fibromyalgia, but with some lifestyle changes and an understanding of what triggers your flare-ups, as well as a combination of treatments, you can better manage the condition.
If you’re dealing with fibromyalgia, ask your doctor whether an option like stem cell therapy and other regenerative medicine treatments can help.
Choosing options that target inflammation and trying to get to the underlying cause of the problem instead of only masking the symptoms can make it possible to live a happy and healthy life with fibromyalgia. To learn more about pain management for Fibromyalgia visit our website or contact us now!
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