Mesenchymal stem cells (MSCs) have inspired a great deal of activity as a novel therapeutic approach. Presently, MSC-based clinical trials are being conducted for a variety of disease conditions, with an increasing number of trials demonstrating safety and efficacy.

Clinical utility of MSCs can be attributed to four key biological properties:

1. Their potential to migrate to sites of inflammation caused by tissue injury when injected intravenously
2. Their potential to differentiate into different cell types
3. Their potential to release different bioactive molecules that can stimulate the recovery of injured cells
4. Their ability to modulate inflammation and accomplish immunomodulatory functions

Currently, over 1,670 MSC clinical trials are in progress across different parts of the world. The majority of these studies are using adipose-derived MSCs and bone marrow-derived MSCs. Nearly 75% (three-quarters) of these clinical studies are using MSCs for the development of regenerative medicine products. Approximately 14% of the studies are using MSCs for disease modeling. The remaining 11% of the studies are using MSCs for drug discovery and cytotoxicity testing applications.

Today, 12 MSC-based therapies have been approved globally. The Republic of Korea has approved five products: Queencell from Anterogen, Cellgram AMI from Pharmicell, Cupistem from Anterogen, Cartistem from Medipost, and NeuroNataR from Corestem. Japan has approved two products: Temcell HS from JCR Pharmaceuticals and Stemirac from Nipro Corporation. India has approved one product: Stempeucel from Stempeutics. Iran has approved MesestroCell developed by Cell Tech Pharmed. EMA in Europe has approved two products: Holoclar from Chiesi Farmaceutici and Alofisel from TiGenix/Takeda. Australia has approved Remestemcel-L from Mesoblast.

Despite this progress, no MSC-based therapeutic have yet received U.S. FDA approval, although the FDA is actively reviewing Mesoblast’s Remestemcel-L.

One of the major bottlenecks to the industry is how to manufacture clinical-grade MSCs on a commercial scale, which Australian regenerative medicine company Cynata Therapeutics (ASX:CYP) is aiming to solve. Cynata Therapeutics is pioneering iPSC-derived MSC production technologies, enabling large-scale therapeutic development. At present, there are at least eight companies who are involved with the development of iPSC-derived MSCs therapeutics (iMSCs), including Cynata Therapeutics, Eterna Therapeutics, Implant Therapeutics, Bone Therapeutics, Brooklyn ImmunoTherapeutics, Fujifilm CDI, Citius Pharmaceuticals, and Kiji Therapeutics.

To fully understand the cell type and its evolution over time, this post considers key dates in the discovery of mesenchymal stem cells (MSCs). [Read more…]