08 Apr R3 Stem Cell Achieves IRB Approval for Regenerative Cell Therapy Study
R3 Stem Cell announced today that the company has achieved IRB Approval for its regenerative study titled, “Safety and Clinical Outcomes Study: Amniotic and Umbilical Cord Tissue Administration for Orthopedic, Neurologic, Urologic, Autoimmune, Cardiac, Renal and Pulmonary Conditions”. The company will be acquiring data for over a dozen different conditions with respect to how effective the outcomes are along with documenting any adverse events.
An IRB is short for Institutional Review Board, which is an accredited third party that evaluates research protocols for safety, patient protection and makes sure the benefits significantly outweigh any risks. Accredited IRBs fall under the purview of the Department of Health and Human Services.
R3 Stem Cell’s study has been placed on clinicaltrials.gov and is currently the only project in America evaluating umbilical and amniotic tissue outcomes for over a dozen different conditions. Conditions being evaluated include COPD, Kidney Failure, Arthritis, Heart Failure, Erectile Dysfunction, RA, Lupus, Neuropathy, Stroke, and several others.
“We did this for numerous reasons, one of which is that it’s important for patients to know an unbiased, accredited third party has evaluated the procedures for safety. In addition, the IRB makes sure all the forms are in layman’s terms and that the protocols maintain a high benefit to risk ratio,” explained R3 CEO David Greene, MD, MBA.
“No other company has done this for amniotic and umbilical cord cell therapies. Why? Because it’s time consuming and expensive, but critical to pushing the field of regenerative medicine forward with these groundbreaking protocols!”, added Dr. Greene.
While the study is patient funded, R3 will subsidize the procedures so that patients will receive a significant discount off the overall cost. The outcomes will be followed by the research staff at regular intervals for over five years.
For those interested in being part of the study, simply call (844) GET-STEM or visit R3StemCell.com to find a provider. It is important to note that regenerative procedures are not currently covered by insurance, and there is a reduced cost to patients for receiving the stem cell procedures.