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HSS Research Institute

ASA (ReNu) Efficacy" Organogenesis Inc. Study: “A Phase 3 Prospective, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Amniotic Suspension Allograft (ASA) in Patients with Osteoarthritis of the Knee”

IRB Number: 2020-2278

Institutional Review Board, Hospital for Special Surgery

February 07, 2022

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.

Principal Investigator

Andreas H. Gomoll, MD

Co-Investigators

Sabrina M. Strickland, MD

Summary

We are conducting a study investigating the effects of Amniotic Suspension Allograft (ASA) injections for knee arthritis. The ASA injection consists of amniotic membrane and stem cells contained within the amniotic fluid. Both have been shown to reduce pain and inflammation from osteoarthritis in the knee.  This is a follow-up to a previous study, which demonstrated safety of the injection and better pain relief than a gel shot. Please note that this is a randomized blinded study, with study participants receiving either the ASA injection or a placebo control injection. If you qualify for this study the costs of your injection would be completely covered
a.    Number of patients: 48
b.    Enrollment period: February 21 2021-February 23, 2023
c.    Duration of study: 2 years

Inclusion/Exclusion Criteria

Inclusion Criteria: 

Patients must meet all of the following criteria: 
1. Males or females 18 years of age or older 
2. Diagnosis of OA of the knee by a combination of clinical and radiographic findings 
3. OA of the knee with Kellgren and Lawrence radiographic classification (Grades 2-4 inclusive,) confirmed by posterior-anterior, weight-bearing, fixed flexion radiography with 10º caudal beam angulation. A specially designed positioning frame will be used to standardize the positioning for image acquisition. 
4. Patients who have failed to adequately respond for at least 6 months to at least two osteoarthritis therapies that include conservative, non-pharmacological therapy and simple analgesics (e.g., acetaminophen); nonsteroidal anti-inflammatory drugs (NSAIDS); avoidance of activities that cause joint pain; exercise; weight loss; physical therapy; and removal of excess fluid from the knee. 
5. Overall pain score of 11 or more over the previous 7 days using the WOMAC Pain scale. 
6. Body mass index < 40 kg/m2 
7. If female, must be postmenopausal (for at least 2 years), surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), sexually abstinent, or willing and able to use 2 methods of contraception from Day 1 through 12 months after treatment) 
8. Males who are not surgically sterile (vasectomy) for at least 6 months prior to screening must confirm a willingness to use adequate methods of contraception from Day 1 through 12 months after treatment) 
9. Willing to agree not to use illicit drugs during the study, and to have illicit drug testing at screening and at later time points, if illicit drug use is suspected during the study 
10. Able to comply with study requirements and complete the full sequence of protocol-related procedures and evaluations, including post-hospitalization, outpatient, and follow-up visits 
11. Able to understand and provide written informed consent 

Exclusion Criteria: 

Patients must not meet any of the following criteria: 
1. Use of pain medication (including non-steroidal anti-inflammatory drugs and CBD oil) less than 15 days before treatment (acetaminophen is allowed) 
2. Regular use of anticoagulants 
3. Symptoms of locking, intermittent block to range of motion, or loose body sensation that could indicate meniscal displacement or an IA loose body 
4. Corticosteroid injection into the index knee within 3 months prior to screening 
5. Viscosupplement (e.g., hyaluronic acid [HA]) injection, platelet-rich plasma injection, bone marrow aspirate or bone marrow aspiration concentrate, placental-derived tissue/cells, adipose tissue, or any other autologous or allogeneic product into the index knee within 6 months prior to screening 
6. Patients with known hypersensitivity reactions to ASA or any of its constituents (e.g., HA, dimethyl sulfoxide) 
 

Contact Information

Andreas H. Gomoll, MD
GomollA@hss.edu

917.260.3677