Institutional Review Board, Hospital for Special Surgery
August 10, 2018
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
This study is investigating the use of a stem cell injection as a treatment for those who suffer from knee osteoarthritis. The stem cells are taken from the bone marrow of your hip and injected into your affected knee. We hope to show that this injection is not only safe, but will improve your pain, function, and overall quality of life. Participation includes completing a follow-up survey at 1 month, 3 months, 6 months, and 1 year post-injection. You will also undergo a follow-up MRI at 1 year post-injection. The first five subjects enrolled will also be asked to come in for a follow-up MRI at 6 months.
Inclusion/Exclusion Criteria: To be included in the study, patients between the ages of 18 and 79 must have confirmed knee osteoarthritis that has been unresponsive to other treatments (e.g., physical therapy, NSAIDs, steroid injections, etc.) for at least 3 months. Only those with Kellgren-Lawrence grade of I or II knee osteoarthritis will be included. Exclusion criteria include presence of loose bodies on MRI, history of meniscal injury, history of surgery on affected knee, intra-articular injection (e.g., hyaluronic acid, PRP, corticosteroid) to affected knee within 6 weeks of study injection, inability to refrain from NSAIDs (e.g., Ibuprofen, Advil, Aleve) for 1 week, current cigarette smokers, and history of alcohol abuse.
Jennifer Cheng, PhD