The stem cell market has grown increasingly complex over the past few years, especially in the regulatory space. The NIH recently had an overwhelming response for participation in its Part 15 public hearing intended to review “Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products.”
With approximately 600 registrations for the events and 100 people and groups interested in presenting, it was clear that individuals across the United States are concerned about these draft guidances that appear to be a further restriction on stem cell therapy within the U.S. The event has since been rescheduled as a two-day public hearing to be held over September 12-13, 2016, in a larger venue, Masur Auditorium, at the NIH campus in Bethesda, MD.
Additionally, the Office of U.S. Senator for Illinois, Mark Kirk, announced the introduction of the REGROW Act in March 2016, a bill designed to “reduce barriers to medical innovation and accelerate the development of new regenerative medicine treatments.” The bill has been exceedingly controversial within the stem cell community, with both dissenters and advocates both voicing strong opinions.
On April 12, the Bipartisan Policy Center and the Regenerative Medicine Foundation hosted “policymakers, scientific and academic experts, practitioners, and patients to discuss the science and benefits of cell therapy and new policies needed to modernize the U.S. regulatory approach for bringing safe and effective treatments to Americans.” Panel discussions and opinions regarding the act can now be seen at the Bipartisan Policy Center website.
Bernard Siegal, organizer of the the Regenerative Medicine Foundation and host of the World Stem Cell Summit, has been an advocate for the bill. The group Patients for Stem Cells has also been supportive of the REGROW Act.
Others, like Regenexx founder Dr. Chris Centeno, are more concerned. In Dr. Centeno’s own words: “I had high hopes for a bill being put forward by a bipartisan group that was hopefully going to allow wider use of cell therapies as the practice of medicine. Regrettably, it looks like that didn’t happen.”
Another powerful organization, the Alliance for Regenerative Medicine (ARM) recently released an official statement about the act. The statement reads, “ARM cannot support the REGROW Act. We continue to believe the proposal does not contain critical statutory protections for patients.”
Furthermore, adipose-derived stem cells have become increasingly utilized by orthopedic doctors for musculoskelal and cosmetic therapy applications, but the FDA has begun to watch and tightly regulate these applications. Recently, the FDA has issued highly-public “warning letters” to clinics that it perceived to be in non-compliance. One of the highest profile cases was a warning letter sent on December 30, 2015 to Dr. Gionis, who operates three stem cell treatment centers:
- Irvine Stem Cell Treatment Center – Irvine, CA
- Miami Stem Cell Treatment Center – Boca Raton, FL
- Manhattan Regenerative Medicine Medical Group – New York, NY
Issued by Mary A. Malarkey, Director of the Office of Compliance and Biologics Quality at the FDA, the warning letter stated:
“…your processing alters the original relevant characteristics of the adipose tissue relating to the tissue’s utility for reconstruction, repair, or replacement. Therefore, the processing would not meet the definition of minimal manipulation for structural tissue such as adipose tissue.”
Other regions of the world have also been addressing issues pertaining to stem cell regulation. In particular, Japan has accelerated its position as a hub for regenerative medicine research, largely driven by support from Prime Minister Shinzo Abe who has identified regenerative medicine and cellular therapy as key to the Japan’s strategy to drive economic growth.
The Prime Minister has encouraged a growing range of collaborations between private industry and academic partners through an innovative legal framework. Most importantly to the stem cell research products marketplace, Japan’s Education Ministry said it is planning to spend 110 billion yen ($1.13 billion) on induced pluripotent stem cell research during the next 10 years, and the Japanese parliament has been discussing bills that would “speed the approval process and ensure the safety of such treatments.”
Clearly, regulation of the stem cell market is at a tipping point, but which direction it will fall is unknown.
While regulatory forces are having a monstrous impact on the market for stem cell therapeutics, they are also affecting the market for stem cell research products, because therapeutic progress is major driver for stem cell innovation. While the global impact of these issues on the market for stem cell products and therapies is unknown, the upside of these policy conversations is that they are bringing stem cells into the spotlight.
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