516
Participants
Start Date
December 14, 2020
Primary Completion Date
July 30, 2023
Study Completion Date
August 19, 2025
Amniotic Suspension Allograft
This investigational product is a cryopreserved product derived from human amnion and cells from the amniotic fluid.
Placebo
Matching placebo is 0.9% normal saline: 4 mL to be injected IA.
NYU Langone Health, New York
Hospital for Special Surgery, New York
Lenox Hill Hospital (Northwell Health), New York
University Orthopedics Center, Altoona
University Orthopedic Center, State College
Lehigh Center for Clinical Research, Allentown
Sinai Hospital of Baltimore, Baltimore
Klein & Associates, MD, PA, Hagerstown
Spectrum Medical, Inc, Danville
M3 Emerging Medical Research, LLC, Raleigh
M3 Emerging Medical Research, LLC, Durham
Moore Orthopedics and Sports Medicine, Morehead City
Coastal Carolina Research Center, North Charleston
PCPMG Clinical Research Unit, LLC, Greenville
Pinnacle Trials, Inc., Stockbridge
AARDS Research, Inc., Aventura
Gulfcoast Research Institute, Sarasota
Central Research Associates, Birmingham
Alabama Clinical Therapeutics, Birmingham
AMR Mobile, Mobile
Affinity Health, Nashville
Affinity Health, Oak Brook
Chicago Clinical Research Institute Inc, Chicago
Rush University Medical Center, Chicago
Methodist Physicians Clinic/ CCT Researc, Fremont
Physician Research Collaboration, Lincoln
Cedar Health Research, LLC, Burleson
Injury Care Research, Boise
Fiel Family & Sports Medicine/ CCT Research, Tempe
Arizona Arthritis & Rheumatology Research, Glendale
Arizona Arthritis & Rheumatology Research, Tucson
Actca, A Member of the Allliance Inc., Los Angeles
University of California at Los Angeles, Los Angeles
Horizon Clinical Research Center, La Mesa
Tri West Research Associates, El Cajon
Stanford Medicine, Redwood City
University of California at Davis, Sacramento
Tufts Medical Center, Boston
Lead Sponsor
Collaborators (1)
Premier Research
OTHER
Organogenesis
INDUSTRY