Amniotic Suspension Allograft for Osteoarthritis

Recruiting in Palo Alto (17 mi)

+36 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Organogenesis

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

Adults over 18 with knee osteoarthritis, a BMI under 40, and pain not relieved by standard treatments can join. They must have tried at least two therapies for six months without success. Women should be postmenopausal or use contraception; men agree to contraception if not sterile. No recent corticosteroid injections in the knee, no significant other illnesses, and no substance abuse.

Inclusion Criteria

may be jurors People who are 18 years or older and are either male or female may serve on a jury.

Males or females 18 years of age or older

Diagnosis of OA of the knee by a combination of clinical and radiographic findings

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Exclusion Criteria

You have received a corticosteroid injection in your knee within the past 3 months before the screening.

Your screening tests or physical examination show important health issues that are not specifically related to knee osteoarthritis. These issues could affect the study or make it harder to understand the results, or they may increase your risk as a participant.

You have received injections or treatments for your knee within the past 6 months, such as hyaluronic acid, platelet-rich plasma, or other substances derived from your own body or from others.

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Treatment Details

Interventions

Amniotic Suspension Allograft (Other)
Placebo (Other)

Trial OverviewThe trial is testing Amniotic Suspension Allograft (ASA), a new treatment for knee osteoarthritis symptoms against a placebo. Participants will receive either ASA or an inactive substance to compare effectiveness and safety.

Participant Groups

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