Human mesenchymal stem cells (hMSCs) are multipotent adult stem cells found in tissue throughout the body, including in the umbilical cord, bone marrow, and adipose tissue. Capable of self-renewing and differentiating into multiple tissues including bone, cartilage, muscle, fat cells, and connective tissue[1], MSCs appear to have a wide range of potential for use as therapeutic purposes for many serious health problems occurring throughout the body.
In this review, Rodriguez-Fuentes et al. examined currently registered (as of July 2020) clinical trials involving mesenchymal stem cells with the goal of analyzing the different applications of MSCs in a clinical setting to demonstrate the growing and broad potential of their therapeutic application relative to the reconstruction of damaged tissue.
As of July 2020, the authors identified 1,138 registered clinical trials (CTs) worldwide using MSCs to investigate their therapeutic potential. Therapeutic applications are a relatively new area of study, evidenced by the fact that only 19 CT studies were started between 1995 and 2005 and over 900 were initiated in the last ten years (2011-present). The majority of these CTs focused on the fields of traumatology, neurology, cardiology, and immunology. Interestingly, of the 1,138 CTs identified in this query, only 18 had published outcomes.
Examining the global distribution of registered CTs, it was observed that CTs are located in 51 countries, with China (228) and the US (186) leading the research.
As part of this review, and in addition to examining the number and geographic locations of registered CTs, the sourcing, isolation and treatment methods, and storage conditions of MSCs used in each clinical trial.
Most of the MSCs used for these CTs were obtained from cells of the iliac crest, placenta, and adipose tissue. All recovered cells underwent steps of purification and expansion prior to use in patients. Additionally, all methods used in these CTs were also found to follow good manufacturing practices (GMP).
Upon completing their review of registered CTs, Rodriguez-Fuentes et al. also observed that medical specialties for the most published studies included (in descending order) cardiology, traumatology, pneumology, neurology, hematology, ophthalmology, and plastic surgery. The most frequent pathologies addressed in these published CT studies included knee osteoarthritis, ischemic heart disease, and dilated cardiomyopathy. While the number of MSCs used varied by study, most utilized around 100 million MSCs.
The authors concluded that most studies analyzed as part of this review demonstrate positive outcomes with no serious adverse effects. While China and the US lead the world in the number of registered MSC clinical trials, the authors point out the fact that many of these CTs have multiple locations in different countries – indicating the importance of, and willingness to, collaborate internationally on this research.
Although most of the conditions for which clinical utility of MSCs have been published are conditions that do not currently have specific treatments with desirable or effective outcomes, there appears to be significant and broad potential for the clinical use of hMSCs without serious adverse events.
While there are currently at least 1,138 registered MSC CTs, there is still much to be examined and understood about MSCs. As such the continually increasing number of CTs including MSCs will help identify and demonstrate the therapeutic potential of these versatile stem cells.
[1] “Mesenchymal stem cells – Latest research and news | Nature.” https://www.nature.com/subjects/mesenchymal-stem-cells.
Source: Mesenchymal Stem Cells Current Clinical Applications. From https://www.sciencedirect.com/science/article/pii/S018844092030638X
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