About Stem Cell Therapy and Our IRB Status
30 min presentation on the evolution of stem cell therapy by Thomas Grogan, MD one of our orthopedic surgeons.
Food and Drug Administration
With our IRB status with the FDA, we are involved in a nationwide data collection on all IRB approved procedures performed in our facilities. This allows a broad base of knowledge coming from other clinics around the US. All clinics and physicians involved are under strict orders to perform these procedures as outlined under established protocols under the IRB. This ensures our patients are receiving the most current and cutting edge techniques that are employed in this study from around the country, and their participation will increase the body of knowledge for future research and development.
I. IRB Organization
1. What is an Institutional Review Board (IRB)?
Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.
The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.
The International Society for Stem Cell Research Handbook about stem cells and their approved use.
We are part of the Cell Surgical Network - This is very, very important. I can't stress enough how important it is that we maintain a network of providers who are skilled and educated in the field of Regenerative Medicine and Interventional Orthopedics. This network requires all providers to adhere to protocols and standards set forth in the IRB mentioned above. This ensures that all outcomes from the study are found consistently across the network. In this way we can set standards across the country to ensure reliable outcomes for patients and maintain safety.
We are very aware of dubious business/medical clinics that are springing up across the world making stem cell promises and procedures that are inconsistent with the science of regenerative and interventional orthopedics. I highly advise if you are considering stem cell therapy that you consult with a reputable medical office or someone within the cell surgical network.