MedTrace Logo

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

NCT04636229 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 516

Last updated 2025-10-16

No results posted yet for this study

Summary

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.

Conditions

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.

Sponsors & Collaborators

  • Premier Research

    collaborator OTHER

  • Organogenesis

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-14
Primary Completion
2023-07-30
Completion
2025-08-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04636229 on ClinicalTrials.gov