Wharton's Jelly Injections for Knee Osteoarthritis

Phase < 1

Recruiting

Research Sponsored by R3 Medical Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with Grade II or III OA on the KL scale (in one knee)

Be over age 30

Must not have

Have had an intra-articular injection of any drug including viscosupplementation in the index knee in the past 6 months

Be on immunosuppressive medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is a small initial study that will look at the safety and feasibility of using Wharton's Jelly allograft injections in patients with knee osteoarthritis. Participants will be divided into three

Who is the study for?

This trial is for individuals with knee osteoarthritis who are interested in trying a new treatment involving injections. Participants will be chosen randomly to receive one of three different doses of the injection.

What is being tested?

The study is testing the safety and how well people can tolerate Wharton's Jelly (WJ) allograft tissue injected into the knee at low, medium, or high doses. It's an early-stage trial to see if this could be a feasible treatment for osteoarthritis.

What are the potential side effects?

Since it’s a pilot study focusing on safety and feasibility, specific side effects aren't listed but may include typical injection-related reactions such as pain, swelling, or infection at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My knee has moderate to severe arthritis.

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I am over 30 years old.

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My pain level is 4 or higher on a scale of 0-10.

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I am a woman who is not currently able to become pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had any knee injections in the last 6 months.

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I am taking medications that suppress my immune system.

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I am planning to have surgery during the study.

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I am not pregnant, breastfeeding, or planning to become pregnant during the study.

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I have a history of organ transplant, rheumatoid arthritis, or an autoimmune disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year for reporting.