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Amniotic Suspension Allograft for Osteoarthritis

Phase 3
Waitlist Available
Research Sponsored by Organogenesis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 52
Awards & highlights
Pivotal Trial

Summary

This trial is testing a new treatment called ASA, which is injected directly into the knee joint. It aims to help patients with knee osteoarthritis by reducing pain and improving joint function. The study will compare the effects of ASA over several months.

Eligible Conditions
  • Osteoarthritis of the Knee

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Aspirin
Secondary study objectives
Incidence of adverse events (AEs)
The difference between ASA- and placebo-treated patients in the WOMAC Stiffness at 6 months
The difference between changes from baseline for ASA- and placebo- treated patients in WOMAC Function at 6 months
+7 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ASAExperimental Treatment1 Intervention
Participants receive a single IA injection of 2 mL of ASA (plus 2 mL of normal saline)
Group II: PlaceboPlacebo Group1 Intervention
Participants receive a single IA injection of 4 mL of normal saline

Find a Location

Who is running the clinical trial?

OrganogenesisLead Sponsor
36 Previous Clinical Trials
3,966 Total Patients Enrolled
2 Trials studying Osteoarthritis
210 Patients Enrolled for Osteoarthritis
Premier Research Group plcIndustry Sponsor
63 Previous Clinical Trials
73,434 Total Patients Enrolled

Media Library

Amniotic Suspension Allograft (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04636229 — Phase 3
Osteoarthritis Research Study Groups: Placebo, ASA
Osteoarthritis Clinical Trial 2023: Amniotic Suspension Allograft Highlights & Side Effects. Trial Name: NCT04636229 — Phase 3
Amniotic Suspension Allograft (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04636229 — Phase 3
Osteoarthritis Patient Testimony for trial: Trial Name: NCT04636229 — Phase 3
~95 spots leftby Dec 2025