A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

474

Participants

Timeline

Start Date

September 6, 2023

Primary Completion Date

August 15, 2025

Study Completion Date

November 30, 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 (41)

10016

NYU Langone Health, New York

10021

Hospital for Special Surgery, New York

10065

Northwell Health, New York

14221

Upstate Clinical Research Associates, LLC, Williamsville

18104

Lehigh Center for Clinical Research, Allentown

21215

Sinai Hospital, Baltimore

21740

Klein & Associates M.D., P.A., Hagerstown

24541

Spectrum Medical, Inc., Danville

28557

West Clinical Research, Morehead City

29406

Clinical Trials of South Carolina, Charleston

30265

Vista Clinical Research, Newnan

30331

CenExcel/ACMR, Atlanta

33126

AppleMed Research Group, LLC., Miami

34232

Gulfcoast Research Institute, Sarasota

35205

Central Research Associates, Inc., Birmingham

35235

Alabama Clinical Therapeutics, LLC, Birmingham

43202

The Ohio State University Wexner Medical Center, Columbus

47714

MediSphere Medical Research Center, Evansville

48085

Oakland Medical Research, Troy

60462

Advanced Quality Medical Research, Inc, Orland Park

60607

Chicago Clinical Research Institute Inc., Chicago

60612

Rush University Medical Center, Chicago

63141

Sundance Clinical Research, St Louis

68114

Quality Clinical Research, Omaha

68516

Physician Research Collaboriation, LLC, Lincoln

73013

Conrad Clinical Research, Edmond

73099

Tekton Research, Yukon

75007

ClinRXResearch INC, Carrollton

75230

Zenos Clinical Research, Dallas

76028

Cedar Health Research, LLC, Burleson

78745

Tekton Research, Austin

84107

JBR Clinical Research, Salt Lake City

85283

Fiel Family & Sports Medicine, Tempe

91767

Dream Team Clinical Research, Pomona

91942

Horizon Clinical Research, La Mesa

92108

TriWest Research Associates, San Diego

92860

Infinity Clinical Research, Norco

94063

Stanford Medicine, Redwood City

94558

Neurovations Research, Napa

99218

Spokane Joint Replacement Center, Spokane

01803

Skylight Health Research, Burlington

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Organogenesis

INDUSTRY

NCT06000410 - A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee | Biotech Hunter | Biotech Hunter