What Are the Most Recent Clinical Trials Using Mesenchymal Stem Cells?


MSCs in Clinical Trials

What Are MSCs Used For?

Besides mesenchymal stem cells being explored in the fight against pneumonia induced by COVID-19, there are numerous other current applications of MSCs in clinical trials. As you may already know, if you’ve read our other blogs, mesenchymal stem cells are a choice candidate in studies targeting degenerative conditions for their ability to restore skeletal tissue and to differentiate into other cell types, including cartilage, bone, connective tissue, and muscle.

The versatility of these cells has caused them to be used with greater prevalence in therapeutic settings. Several clinical trials have taken place to test the safety and efficacy of mesenchymal stem cells in patients with graft versus host disease (GvHD), autism, cerebral palsy, Crohn’s disease (CD), multiple sclerosis, (MS) systemic lupus erythematous (SLE), rheumatoid arthritis (RA) and type1 diabetes.  Successful use of these cells has been seen in multiple organs in cases regarding the repair of cardiovascular, lung and spinal cord injuries, autoimmune diseases, liver, bone, and cartilage diseases. MSCs are also able to be administered in a way that best suits the condition, via intravenous for immunological disorders, transplantable scaffolds in cases of bone repair, or direct application to the injury site via local injections, as is the case for most other types of tissue injuries.

These adaptive, master-builder cells have seen an increase in research interest over the past several years. Let’s take a brief look at the most current applications of mesenchymal stem cells being used in clinical trials.

How are MSCs Being Used in Regard to COVID-19?

With the widespread effects of the COVID-19 virus across the globe, scientists, clinicians, and medical professionals are scrambling to find an immediate solution to treating symptoms while awaiting a highly anticipated vaccine in the pipeline. A search on clinicaltrials.gov with the terms COVID-19 and mesenchymal stem cells revealed a list of 21 clinical trials. In our recent blog, we discussed the clinical trials taking place in response to COVID-19, which included the use of umbilical cord-derived mesenchymal stem cells. It is suspected that this number will climb as the FDA fast-tracks approval for additional clinical research as COVID-19 cases continue to rise.

In a source interview done with Ross Macdonald, CEO of Cynata Therapeutics, a question was posed about the logistics of stem cell therapy in our current pandemic. He explained, “The standard process, if one wanted to do a clinical study in patients with coronavirus infection using MSCs, is that you'd submit that to the regulatory agencies in the relevant geography – the US FDA (MD, USA), the MHRA (London, UK), or the TGA (Canberra, Australia). That trial would be reviewed and, if thought appropriate, approved to go ahead. That takes time and lots of money but is the normal process. However, the situation right now is extraordinary, and that's leading to changes almost as we speak.”

Time is of the essence; we are already seeing a unique response from the FDA in the approval of innovative stem cell therapy trials. The Miami Herald reported last week the granting of emergency federal approval to use stem cell therapy on patients suffering severe lung inflammation from COVID-19. The treatment is set to begin this week, starting with a small number of patients. The preservation of and access to cord tissue stem cells could potentially treat an onset of conditions that currently exist and that have not yet been encountered, such as the case with COVID-19.

Other reports also reveal promising results coming out of previous studies evaluating the efficacy of MSCs in the repair of damaged vital organs in therapies used in the treatment of type 2 diabetes, autoimmune disease, spinal cord injury, GVHD, and several other diseases with high immunity rates. These outcomes have been reported to suggest that, “ MSCs could recover the pulmonary microenvironment, protect alveolar epithelial cells, intercept pulmonary fibrosis, and cure lung dysfunction and COVID-19 pneumonia.”

How are MSCs Being Used in Other Clinical Trials?

In an article that came out earlier this month in the Stem Cells Journal, it was discovered that human umbilical cord blood‐derived MSCs (hUCB‐MSCs) have a positive therapeutic effect on atopic dermatitis (AD). We also know that MSCs play a role in treating injury‐induced tissue fibrosis and controlling tissue inflammation. The article reports that the beginning of 2019 saw 920 clinical trial studies involving MSCs. According to clinicaltrials.gov, studies include MSCs in the treatment of lupus nephritis, bronchopulmonary dysplasia, multiple sclerosis, acute respiratory distress syndrome, knee osteoarthritis, spinal cord injury, chronic renal failure due to kidney disease, ischemic cardiomyopathy, rotator cuff repair, burn wounds, cystic fibrosis, and many others. More specifically, the MSCs derived from cord tissue have been used in clinical research for the treatment of ALS, Alzheimer’s, heart disease, stroke, and several other conditions.

The anti-inflammatory properties of MSCs in the treatment of respiratory diseases were confirmed by 17 completed clinical studies, with another 70 similar registered trials. The mesenchymal stem cells found in cord tissue are being utilized in several new clinical trials as a way to combat the effects of COVID-19. As more alternative treatments become approved alongside increased demand for effective and readily available solutions, the industry will continue to shift to accommodate the needs of people rapidly. Current news and research are suggesting a trend in the use of umbilical cord mesenchymal stem cells for therapeutic and curative treatments. As research results start to unfold in more significant numbers, we will likely see the dawn of a new era in terms of stem cell therapies. Today, cord blood has been approved by the FDA to treat nearly 80 diseases. What can be said of cord tissue stem cells has yet to be told, but what we see from clinical trials and current findings during this pandemic is that cord tissue MSCs may have a story to tell in the future of standardized stem cell therapies.

Last Updated on: 04/27/2020 by Amy Schmidt