In this webinar, originally presented via RegMedNet on April 15th, 2021, the Regulatory experts at Cook MyoSite walk attendees through the company's experience applying for the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation, receiving an initial rejection, and reapplying to successfully obtain the designation.
Why participate in a clinical trial?
Clinical trials are studies in which new treatments (drugs, devices, or biologics) are tested using human volunteers. These potential new treatments might be tested against the efficacy of another treatment intended for the same condition, be tested against a placebo, or against an untreated group (more on that in our previous post). Clinical trials provide the necessary rigorous testing of a treatment before it is approved for use in the general population.
Stem cells have been the center of medical intrigue for much of the last few decades. During this time, the differences between the popular and the scientific conceptions of what is and isn’t a stem cell have grown. Often, the public's understanding of stem cells is far narrower than how the term is applied by scientists. What is a stem cell? Does Cook MyoSite work with stem cells?
Since ancient times, humans have told stories about the body’s natural ability to regenerate. In the 8th century B.C., the Greek poet Hesiod wrote about the regenerative capabilities of the Titan Prometheus’s liver:
Topics: regenerative medicine