Regenerative Medicine Edition Ep.10: FDA Regulatory Process and Clinical Trials

To claim credit for this episode, visit: www.ce.mayo.edu/regmedonline

Guest: Drew M. Witter, CCRP

Host: Darryl S. Chutka, M.D. (@ChutkaMD)

“Stem Cell Clinics” throughout the U.S. promote stem cell therapy for a variety of health conditions including osteoarthritis, autism, macular degeneration, Parkinson’s Disease, Alzheimer’s Disease and most recently COVID-19 infections. How can our patients be assured that the regenerative medicine therapy effectively treats their health condition and the products they receive are safe? In this podcast, we discuss regulations regarding regenerative medicine, the process of obtaining FDA-approval and which regenerative medicine therapies are FDA-approved. Our guest will be Drew Witter, a Program Manager from the Office of Research and Regulatory Support at the Mayo Clinic.

Specific topics discussed:

• Process of taking regenerative medicine from the research lab to the clinical practice
• How regulators ensure the safety and effectiveness of regenerative therapies
• The process of acquiring FDA-approval
• Regenerative medicine therapies that are FDA-approved
• How patients and clinicians learn of FDA-regulated regenerative medicine clinical trials

Additional resources:

• Clinical Trials available at Mayo Clinic through the Center for Regenerative Medicine: https://www.mayo.edu/research/centers-programs/center-regenerative-medicine/patient-care/clinical-trials
• U.S. National Library of Medicine: https://www.clinicaltrials.gov/
• Center Watch: https://www.centerwatch.com/

Additional educational opportunities from Mayo Clinic:

• https://www.mayo.edu/research/centers-programs/center-regenerative-medicine/education
• https://college.mayo.edu/academics/biomedical-research-training/phd-program/tracks/regenerative-sciences/

Connect with the Mayo Clinic’s School of Continuous Professional Development online at https://ce.mayo.edu/ or on Twitter @MayoMedEd.