Injections of Wharton's Jelly Allograft for Knee Osteoarthritis
Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for
This study is testing whether injections of Wharton's Jelly can safely help people with knee osteoarthritis feel less pain and move better.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | R3 Medical Research Industry-sponsored |
| Locations | 5 sites (Scottsdale, Arizona and 4 other locations) |
| Trial ID | NCT06608134 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the safety and feasibility of intra-articular injections of Wharton's Jelly allograft in patients with knee osteoarthritis. Participants will be randomized into three groups receiving different doses of the allograft: low, medium, or high. The study will monitor patients for one year to assess safety, pain relief, and functional improvements. No control group will be used, as the primary focus is on evaluating the safety of the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 30 with Grade II or III knee osteoarthritis and a pain score of 4 or higher.
Not a fit: Patients who have taken pain medications or NSAIDs within two weeks prior to the injection may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for pain relief and improved function in patients with knee osteoarthritis.
How similar studies have performed: While this approach is novel, similar studies using allografts for joint pain have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be over age 30 * Diagnosed with Grade II or III OA on the KL scale (in one knee). * Body Mass Index (BMI) \<50Kg/m2 * Pain score of 4 or more on the Numeric Pain Rating Scale (NPRS) * Female patients must be abstinent, surgically sterilized or postmenopausal * Premenopausal females must have a negative pregnancy test, on contraceptive measures and do not anticipate pregnancy during the duration of the study. * Be willing and capable of giving written informed consent to participate in English. * Be willing and capable of complying with study-related requirements, procedures and visits in English. Exclusion Criteria: * Have taken any pain medication including nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to study injection date. * Use anticoagulants have a substance abuse history and fail to agree not to take any knee-symptom modifying drugs during the course of the study without discussing and reporting the use to the site principal investigator and study team. * Have had an intra-articular injection of any drug including viscosupplementation in the index knee in the past 6 months. * Have had surgery on the index knee with the past 6 months. * Had a traumatic injury to the index knee with the past 3 months. * Planned elective surgery during the course of the study. * A history of organ or hematologic transplantation, rheumatoid arthritis, or other autoimmune disorders. * Be on immunosuppressive medications. * Have a diagnosis of carcinoma with the past 2 years. * Have a knee infection or have used antibiotics for knee infection within the past 3 months. * Have participated in any other clinical trial or treatment (not just for the knee, but for any reason) with any investigational product within the past 30 days prior to inclusion of study. * Female patients who are breast feeding or are pregnant or desire to become pregnant during the course of the study. * Contraindications to radiographic or MRI imaging. * Serious neurological, psychological or psychiatric disorders. * Injury or disability claims under current litigation or pending or approved workers compensation claims. * Have a known drug allergy to amphotericin-B, ciprofloxacin, gentamycin, penicillin, or streptomycin.
Where this trial is running
Scottsdale, Arizona and 4 other locations
- R3 Anti Aging Scottsdale — Scottsdale, Arizona, United States (Recruiting)
- R3 Anti Aging Beverly Hills — Beverly Hills, California, United States (Recruiting)
- Optimal Medical Group — Fresno, California, United States (Recruiting)
- Scheer Medical Wellness — New York, New York, United States (Recruiting)
- Dr. Duc (Steve) Le, MD — Cleveland, Texas, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.