Injections of Wharton's Jelly Allograft for Knee Osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• SVF cellular mix, secretome, and knee response in osteoarthritis

  This study tests the cellular composition and secretome of research-only adipose-derived SVF in adults with knee OA who are already planned to receive an autologous SVF injection as part of their care.

  Recruiting Yonsei University · Seoul · NCT07898501

• Effect of a Resistance Exercise Program on IGF-1 Levels in Knee Osteoarthritis

  A structured 8-week resistance exercise program is being tested to see if it changes blood IGF-1 levels and improves knee OA symptoms in adults with knee OA and metabolic traits.

  Recruiting Sisli Hamidiye Etfal Training and Research Hospital · Istanbul, Istanbul · NCT07890155

• 2-mm subchondral drilling vs sequential 4-mm and 2-mm drilling during CARTISTEM implantation for knee cartilage defects

  This study tests whether drilling the knee with a 2-mm drill alone works as well as sequential 4-mm then 2-mm drilling when combined with CARTISTEM treatment for medial knee cartilage defects.

  Recruiting Yonsei University · Seoul · NCT07881445

• Undenatured Type II Collagen for Knee Osteoarthritis Pain (Three-Arm Trial)

  This study tests whether taking undenatured type II collagen capsules once daily for 4 months can reduce knee pain in adults with knee osteoarthritis, compared with two collagen formulations and a placebo.

  Recruiting Universidad Católica San Antonio de Murcia · Murcia, Murcia · NCT07870967

• Serum Fetuin‑A and COMP levels in knee osteoarthritis

  This study tests whether levels of Fetuin‑A and COMP in the blood relate to how severe knee osteoarthritis is in patients compared with healthy volunteers.

  Recruiting Antalya Training and Research Hospital · Antalya · NCT07706569

• Pain relief for knee osteoarthritis: a 2nd phase study of LY4065967 vs placebo

  Researchers are testing whether LY4065967 can help reduce knee pain from osteoarthritis in adults, compared with placebo.

  Recruiting at 36 sites Phase 2 Eli Lilly and Company · Birmingham, Alabama and 35 other locations · NCT07641517

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.