Institutional Review Board, Hospital for Special Surgery
July 13, 2016
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.
The objective of this clinical investigation is to evaluate the safety and efficacy of ReNu™ knee injection on patients with moderate osteoarthritis. The ReNu™ injection consists of a mixture of allogeneic, human amniotic fluid derived stem cells and morselized human amnion for the symptomatic treatment of osteoarthritis. The effects will be measured primarily through patient-reported outcomes questionnaires after a single knee injection of ReNu™. Safety will be monitored by clinical examination of the injected joints at study visits, a comparison of baseline and 12 month knee x-ray, and laboratory testing including a complete metabolic profile, complete blood counts, inflammatory markers and serum immunoglobulins.
Patients will be randomized to receive either the ReNu™ injection, standard of care Monovisc injection or a placebo saline injection. This study will include 12 patients total. Follow-up will last for 1 year following the injection, including up to 8 follow-up visits.
This study will include patients with moderate knee osteoarthritis determined by a combination of clinical and radiographic findings, age 18 and older, and having a BMI less than 40.
Patients will be excluded if they are younger than 18, have had knee surgery within the past 12 months, or if they are females who are pregnant/planning on becoming pregnant in the next 12 months.