As the cell therapy market continues to grow, it’s important to note the similarities between medical device and cell therapy clinical trials. To help illustrate this, we’ve created an infographic, “Cell Therapy: The Fourth Pillar of Healthcare,” which is available for download.
Currently three main pillars of medicine exist, including biologics, medical devices, and pharmaceuticals. These pillars of healthcare have strong guidelines and regulations in place. In the U.S., the Food and Drug Administration is beginning to piece together a foundation for an emerging medical industry.
History has shown the three pillar system has been highly successful, improving the lives of millions of people worldwide. However, there are still unmet medical needs.
An article by Chris Mason discusses an emerging fourth pillar in the industry is cell therapy. Cell therapy is innovative but certainly not new technology. In layman’s terms, cell therapy consists of introducing new cells into an area of the body in order to treat disease. Cell therapy has 200 years rooted in medical history, including: organ and bone marrow transplants, blood transfusion, and in vitro fertilization, just to name a few.
With cell therapy’s roots in history and consisting of a unique therapeutic platform technology, this means there is potential for enormous growth in the industry. The spectrum of cell therapies is highly diverse but broadly broken down into two major components:
- Autologous patient specific therapies
- Allogeneic universal cell therapies
In simple terms, autologous cell therapy involves harvesting cells from that patient, or from a single person or group of people considered universal donors. Allogeneic cell therapy can involve harvesting cells from one or more universal donors. These cells would then be expanded in a manufacturing setting and cryopreserved for later use.
Currently there is a broad spectrum of activity in the industry with eight FDA/European Medicines Agency (EMA)-approved cell therapies. Will that number rise? In the last 10 years, more than 2,500 cell therapy trials have occurred, with the majority still enrolling and collecting data. These studies included more than 50 percent at the phase II and III stages, which are critical in determining effectiveness.
So where will we be in five to 10 years? The estimates based on the other pillars in the industry and better success rates than its counterparts (biologics and pharmaceuticals) would lead us to believe we could possibly see more than 100 regulatory approvals in that time.
The FDA continues the process of building a foundation for cell therapy, as it is now emerging as a major therapeutic force and fast-growing sector of healthcare across a wide range of medical indications. Even though cell therapy trials share similarities to medical device trials, cell therapy has its own requirements and challenges that the FDA will need to consider in the regulation of this sector.
Please take time to download IMARC Research’s new infographic depicting the similarities between medical device trials and cell therapy clinical trials.