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Today, the term MSC describes a class of cells that have historically been known as mesenchymal stem cells, mesenchymal stromal cells, and medicinal signaling cells, among other names. The clinical utility of MSCs is primarily attributed to their key biological properties, which include:
- Their potential to migrate to sites of inflammation caused by tissue injury when injected intravenously
- Their potential to release different bioactive molecules that can stimulate the recovery of injured cells
- Their ability to prevent inflammation and mediate anti-fibrotic effects
- Their capacity to facilitate immunomodulatory functions
According to preclinical and clinical evidence, MSC therapy for immune and inflammatory disorders shows particular promise, with researchers exploring the clinical applications of MSC-derived therapeutics and exosomes for the treatments that include autoimmune diseases, osteoarthritis, inflammatory liver disease, pulmonary diseases, graft rejection, and beyond. Growing interest is also being shifted to allogeneic MSCs since can be made available as off-the-shelf products. Today, MSCs are finding use within in emerging applications, such as tissue engineering, organoids, exosome production, cosmeceuticals, and cultured meat. Furthermore, iPSC-derived MSCs are being explored for their role in the development of MSC therapeutics since these MSCs can be economically produced in uniform batches at nearly infinite scale.
In a previous analysis completed July 14, 2021, there were approximately 1,014 MSC-based clinical trials, among which 197 of these were trials involving MSC-derived exosomes and 124 of them were trials involving the use of MSC-derived therapeutics for the treatment of COVID-19 and its complications. By January 5, 2023, the number of MSC clinical trials increased to approximately 1,416, which was a dramatic increase (39.6%) over this short period. Since that time, the number of MSC clinical trials underway worldwide has continued to trend upward.
Interesting, during this time, the number of clinical trials involving MSC-derived exosomes declined to only 10, while the number of COVID-19 studies involving MSC therapeutics dropped to zero. This is because widespread vaccination efforts, the success of other COVID-19 therapies, and declining infection rates have lowered the global interest in MSC-derived therapeutics for the treatment of COVID-19.
MSC Clinical Trials
Today, only 88 clinical trials using MSCs have reached Phase III, indicating that a limited number of MSC products have near-term market potential and the therapeutic market for MSCs remains early-stage. Presently, only ten MSC-based products have received regulatory approvals, which include nine cell therapy approvals and one tissue engineering approval.
The approved MSC products are Alofisel for perianal fistulas, Prochymal for GvHD, Temcell HS inj for GvHD, Queencell for subcutaneous tissue defects, Cupistem for Crohn’s fistula, Neuronata-R for amyotrophic lateral sclerosis, Cartistem for knee articular cartilage defects, Stemirac for spinal cord injury, Stempeucel for critical limb ischemia, and Cellgram-AMI for acute myocardial infarction. Many of these companies, including Mesoblast, Athersys, Pluristem, Stempeutics, and Cynata, are now repurposing their MSC products for new indications.
MSC-based cosmeceuticals are another emerging field, with several product approvals anticipated by 2025. Clean meat is an exciting field as well, with several market competitors now utilizing MSCs for the production of lab-grow meat and animal products. Importantly, tthe U.S. FDA approved the first lab-grown chicken meat on 17th November, 2022. Based on progress within the fields of cell therapy, gene therapy, tissue engineering, exosome manufacturing, cosmeceutical application, and clean meat production, there will be a growing need for MSCs to be supplied in rapidly growing quantities for use within clinical trials and product development.
This represents a significant opportunity for companies who specialize in manufacturing MSCs, as well as companies (CMOs and CDMOs) who offer contract manufacturing services to support MSC market growth.
Despite challenges within the field, MSCs represent the most studied stem cell type within the scientific literature and the most commonly administered stem cell type with clinical trials worldwide.
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