Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee

PHASE3CompletedINTERVENTIONAL
Enrollment

516

Participants

Timeline

Start Date

December 14, 2020

Primary Completion Date

July 30, 2023

Study Completion Date

August 19, 2025

Conditions
Knee Osteoarthritis
Interventions
BIOLOGICAL

Amniotic Suspension Allograft

This investigational product is a cryopreserved product derived from human amnion and cells from the amniotic fluid.

DRUG

Placebo

Matching placebo is 0.9% normal saline: 4 mL to be injected IA.

Trial Locations (38)

10016

NYU Langone Health, New York

10021

Hospital for Special Surgery, New York

10075

Lenox Hill Hospital (Northwell Health), New York

16602

University Orthopedics Center, Altoona

16801

University Orthopedic Center, State College

18104

Lehigh Center for Clinical Research, Allentown

21215

Sinai Hospital of Baltimore, Baltimore

21740

Klein & Associates, MD, PA, Hagerstown

24541

Spectrum Medical, Inc, Danville

27612

M3 Emerging Medical Research, LLC, Raleigh

27704

M3 Emerging Medical Research, LLC, Durham

28557

Moore Orthopedics and Sports Medicine, Morehead City

29406

Coastal Carolina Research Center, North Charleston

29501

PCPMG Clinical Research Unit, LLC, Greenville

30281

Pinnacle Trials, Inc., Stockbridge

33180

AARDS Research, Inc., Aventura

34232

Gulfcoast Research Institute, Sarasota

35205

Central Research Associates, Birmingham

35235

Alabama Clinical Therapeutics, Birmingham

36608

AMR Mobile, Mobile

37203

Affinity Health, Nashville

60523

Affinity Health, Oak Brook

60607

Chicago Clinical Research Institute Inc, Chicago

60612

Rush University Medical Center, Chicago

68025

Methodist Physicians Clinic/ CCT Researc, Fremont

68516

Physician Research Collaboration, Lincoln

76028

Cedar Health Research, LLC, Burleson

83713

Injury Care Research, Boise

85283

Fiel Family & Sports Medicine/ CCT Research, Tempe

85306

Arizona Arthritis & Rheumatology Research, Glendale

85704

Arizona Arthritis & Rheumatology Research, Tucson

90036

Actca, A Member of the Allliance Inc., Los Angeles

90095

University of California at Los Angeles, Los Angeles

91942

Horizon Clinical Research Center, La Mesa

92020

Tri West Research Associates, El Cajon

94063

Stanford Medicine, Redwood City

95186

University of California at Davis, Sacramento

02111

Tufts Medical Center, Boston

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Premier Research

OTHER

lead

Organogenesis

INDUSTRY

NCT04636229 - Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee | Biotech Hunter | Biotech Hunter