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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Organogenesis
Study ID
NCT06000410
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Amniotic Suspension Allograft — BIOLOGICAL
    This investigational product is a cryopreserved product derived from human amnion and cells from the amniotic fluid.
  • Placebo — DRUG
    Matching placebo is 0.9% normal saline: 4 mL to be injected IA.

Study Details

This study is being conducted to evaluate the efficacy and safety of ASA compared to placebo in the management of osteoarthritis (OA) symptoms of the knee.

Key Dates

First listed
Aug 21, 2023
Start date
Sep 6, 2023
Status verified
Apr 2026
Primary completion
Aug 15, 2025
Completion
Nov 30, 2025

Study Design

Enrollment
594 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ASA
    Participants receive a single IA injection of 2 mL of ASA (plus 2 mL of normal saline)
  • Placebo Comparator: Placebo
    Participants receive a single IA injection of 4 mL of normal saline

Primary Outcome Measure

The difference in change from baseline in WOMAC Pain scale at 6 months between ASA- and placebo-treated patients [ Time Frame: Baseline to Week 26 ]

Locations (41)

FacilityCityStateZIPSite coordinators
Alabama Clinical Therapeutics, LLCBirminghamAlabama35235-
Central Research Associates, Inc.BirminghamAlabama35205-
Fiel Family & Sports MedicineTempeArizona85283-
Horizon Clinical ResearchLa MesaCalifornia91942-
Neurovations ResearchNapaCalifornia94558-
Infinity Clinical ResearchNorcoCalifornia92860-
Dream Team Clinical ResearchPomonaCalifornia91767-
Stanford MedicineRedwood CityCalifornia94063-
TriWest Research AssociatesSan DiegoCalifornia92108-
AppleMed Research Group, LLC.MiamiFlorida33126-
Gulfcoast Research InstituteSarasotaFlorida34232-
CenExcel/ACMRAtlantaGeorgia30331-
Vista Clinical ResearchNewnanGeorgia30265-
Chicago Clinical Research Institute Inc.ChicagoIllinois60607-
Rush University Medical CenterChicagoIllinois60612-
Advanced Quality Medical Research, IncOrland ParkIllinois60462-
MediSphere Medical Research CenterEvansvilleIndiana47714-
Sinai HospitalBaltimoreMaryland21215-
Klein & Associates M.D., P.A.HagerstownMaryland21740-
Skylight Health ResearchBurlingtonMassachusetts01803-
Oakland Medical ResearchTroyMichigan48085-
Sundance Clinical ResearchSt LouisMissouri63141-
Physician Research Collaboriation, LLCLincolnNebraska68516-
Quality Clinical ResearchOmahaNebraska68114-
Hospital for Special SurgeryNew YorkNew York10021-
Northwell HealthNew YorkNew York10065-
NYU Langone HealthNew YorkNew York10016-
Upstate Clinical Research Associates, LLCWilliamsvilleNew York14221-
West Clinical ResearchMorehead CityNorth Carolina28557-
The Ohio State University Wexner Medical CenterColumbusOhio43202-
Conrad Clinical ResearchEdmondOklahoma73013-
Tekton ResearchYukonOklahoma73099-
Lehigh Center for Clinical ResearchAllentownPennsylvania18104-
Clinical Trials of South CarolinaCharlestonSouth Carolina29406-
Tekton ResearchAustinTexas78745-
Cedar Health Research, LLCBurlesonTexas76028-
ClinRXResearch INCCarrolltonTexas75007-
Zenos Clinical ResearchDallasTexas75230-
JBR Clinical ResearchSalt Lake CityUtah84107-
Spectrum Medical, Inc.DanvilleVirginia24541-
Spokane Joint Replacement CenterSpokaneWashington99218-

Find similar trials in Birmingham, AL

Nationwide
Osteoarthritis (other) trialsOrthopedics trialsMusculoskeletal disorders trials
By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
Alabama Clinical Therapeutics, LLC· Birmingham, ALCentral Research Associates, Inc.· Birmingham, ALFiel Family & Sports Medicine· Tempe, AZHorizon Clinical Research· La Mesa, CANeurovations Research· Napa, CAInfinity Clinical Research· Norco, CA

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