AACT advocates for the safe deployment of cellular therapies within informed regulatory oversight.
AACT’s diverse membership works to increase public awareness and facilitate increased patient access to regenerative medicine.
Leslie Miller, M.D., F.A.H.A., F.A.C.C.
Timothy Ganey, M.D., Ph.D.
AACT Executive Board Member speaks at FDA Public Hearing
Chairman of the AACT Executive Board, Dr. Leslie Miller, Speaks at FDA Public Hearing
Excerpt. . . Read Full Presentation HERE
Importantly, we believe that such a Registry could address most of the valid criticisms and concerns about the current unrestricted use of cell therapy.In order to participate, a clinic would have to meet the following rigorous criteria:
1. TO ADDRESS CONCERNS ABOUT INCOMPLETE DATA: Agree to enroll every patient treated for every indication and provide de-identified data on indication, symptoms, demographics, etc.
2. TO ADDRESS THE VARIABLE QUALITY OF CELLS DELIVERED: Must obtain certification of cell preparation lab either on site or the vendor, with complete data on source, prep, type and number, quality and route of delivery.
3. TO ASSURE USE OF VALID TREATMENTS STRATEGIES: Use only IRB approved protocols for every indication based on published data
4. TO ADDRESS THE MAJOR CONCERN THAT PATIENTS GET VARIABLE AND POTENTIALLY INFLATED EXPECTATIONS OF THERAPY: Propose the use of a novel scripted narrative that can be reviewed and approved by the FDA,which would be videotaped and provided to each patient to assure fair and balanced information is given to every patient, with time to allow family members to review and ask questions of the provider to a much more uniform and informed consent process. It would also include a consent to provide required follow-up data.
5. TO ADDRESS THE LACK OF RELIABLE/MEANINGFUL DATA: The use of endpoints/metrics utilized in published clinical trials at uniform time points in every patient by trained/objective observers, to document both good and adverse outcomes for each indication
6. TO ASSURE RELIABILITY AND INDEPENDENCE OF THE DATA: Use of an indepedent company to control all data acquisition, storage, and use.
7. TO ASSURE COMPLIANCE WITH DATA SUBMISSION: Agree to submit all data within 1 month of each uniform time or be subject to temporary suspension from further therapy until data is up to date.
8. ONE OF THE MOST IMPORTANT ASPECTS OF THE DATA IN THE REGISTRY: Complete transparency and ability for the FDA to audit every aspect of the data including outcomes, as well as access for patients who are seeking cell therapy and identify the highest quality centers and their outcomes with real-tme data available.
To people in the United States passionate about improving patient outcomes, AACT is the grassroots movement raising awareness for regenerative medicine.
Physicians will have access to valuable resources such as disease-specific information, regulatory guidelines, regenerative medicine resources, and much more.
The Alliance for the Advancement of Cellular Therapies is dedicated to the ethical, efficacious, and expeditious advancement of veterinary cell therapies for animals.