FDA claims making identical copies of a person’s own stem cells is manufacturing a drug
October 1, 2012 – HOUSTON, TX – Celltex Therapeutics Corp. announced today that it has received a letter, dated Sept. 24, 2012, from the U.S. Food and Drug Administration. The letter stated the agency’s opinion that the process Celltex uses to multiply adult stem cells is subject to FDA regulation as biological drug manufacturing. The issue is a key one as stem cell therapy for patient care outside of an academic institution is a new frontier, yet there are a variety of technologies being used throughout the United States, often creating complex legal and regulatory questions.
David Eller, CEO and President of Celltex, stated:
Celltex makes identical copies of an individual’s own stem cells and therefore should not be subject to FDA regulation as drugs. However, the FDA said our process causes the cells to be considered biological drugs and thus is subject to those regulations. We respectfully but firmly disagree with the FDA and intend to contest the agency’s opinion within its administrative procedures. We are considering all options as we work with the agency toward a resolution.
FDA’s letter also repeats its earlier observations from an April inspection of Celltex’s laboratory. While Celltex provided detailed responses in April, May, June, July and August, now FDA tells us it needs more information. We will answer FDA’s questions in whatever detail the agency requests.”
We will meet FDA’s requirements, no matter how high the hurdles may be, to ensure access to this technology. Celltex remains fully committed to advance the most promising new field in human health in decades — regenerative medicine. We also remain committed to doing so safely, and we will continue to comply with federal and state agency requirements.
As we work with the FDA, Celltex will continue to make advances on the frontier of regenerative medicine, and we expect to have several significant announcements in the coming weeks on these matters:
- Celltex is preparing Investigational New Drug (IND) clinical trials focused on the effectiveness of autologous adult stem cells for specific conditions, such as multiple sclerosis, osteoarthritis and macular degeneration.
- Enrollment in Celltex’s current clinical trials has reached the goal of 200 patients who received their own stem cells from their physician-investigators. Data collection and analysis have commenced, and results are expected to be published in 2013. This will represent the largest, and potentially the most important, autologous adult mesenchymal stem cell study conducted in the United States.
“Celltex is committed to developing the promise of regenerative medicine into a reality for doctors and their patients,” Mr. Eller said. “We sponsor clinical trials to better understand the therapeutic impact and monitor the safety of adult stem cell therapy, and we are confident that our research will help implement effective treatments for patients suffering from a variety of medical conditions.”