Evaluating a new treatment for knee osteoarthritis using adipose tissue allograft

A Phase 1/2a, Multicenter, Randomized, Controlled, Single-Blind, Dose-Finding Study to Evaluate the Safety and Efficacy of Cryopreserved Devitalized Adipose Tissue Allograft (BRC-OA) for Pain Treatment in Subjects With Mild to Severe Osteoarthritis (OA) of the Knee

This study is testing a new treatment using donated fat tissue to see if it can help people with knee osteoarthritis feel less pain and improve their knee function.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Britecyte (Research network)
• Drugs / interventions: prednisone
• Locations: 6 sites (Baltimore, Maryland and 5 other locations)
• Trial ID: NCT06828666 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of a cryopreserved devitalized adipose tissue allograft, known as BRC-OA, in patients suffering from knee osteoarthritis. The study is divided into two parts: the first part focuses on safety evaluation with a small group of participants receiving varying doses of the treatment, while the second part involves a randomized controlled phase comparing the treatment against a placebo. Participants will be monitored for pain relief and overall knee function throughout the trial.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-80 with a diagnosis of knee osteoarthritis who have not found relief from standard pain management therapies.

Not a fit: Patients with severe knee deformities or those who have not previously tried standard pharmacological treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for pain relief in patients with knee osteoarthritis.

How similar studies have performed: While the use of adipose tissue in treatment is gaining interest, this specific approach is relatively novel and has not been extensively tested in similar studies.

Eligibility criteria

Inclusion Criteria:

1. Males or females 18-80 years of age, inclusive
2. Diagnosis of OA in one or both knees supported by documentation of clinical and radiographic findings(KL Grades 2-4) up to 6 months prior to screening:

   1. Diagnosis of degenerative or post-traumatic OA of the knee supported by documentation of clinical and radiographic findings up to 6 months prior to screening
   2. Degenerative meniscal tears allowed as long as there are no pending surgeries
   3. Flexion Contraction and Valgus/Varus deformity allowed if \< 10 degrees
3. Subject must have tried for at least 3 months and failed on at least two of the following pharmacological standard of care therapies in the past 12 months:

   1. Acetaminophen
   2. NSAID (e.g., ibuprofen, naproxen)
   3. Opioid (e.g., tramadol)
   4. Topical NSAID (e.g., diclofenac gel)
   5. Intra-articular injections (e.g., corticosteroids, hyaluronic acid)
4. Subjects knee pain persists for at least 12 weeks prior to screening and does not improve with pain medications (e.g., NSAIDs, acetaminophen, tramadol, etc.) and/or other nonoperative treatment options
5. Index knee WOMAC pain subscale score of ≥ 40 on a normalized/standardized scale of 0 to 100 at screening visit Note: The index knee in subjects with bilateral OA of the knees is the one with worse pain with walking. Where both knees have equal pain with walking, then the knee on the subject's dominant side will be designated the index knee.

Exclusion Criteria:

1. BMI greater than 40 kg/m2
2. Previous IA injections (e.g., corticosteroid, hyaluronic acid (HA), platelet rich plasma (PRP), etc.) into the index knee within 3 months prior to screening
3. Prior Partial Joint Replacement (PJR) or Total Joint Replacement (TJR) of one or both knees
4. Knee surgery in the previous 6 months prior to enrollment and/or planned knee surgery during the study
5. Symptomatic OA of the hips, spine, or ankle that would interfere with the evaluation of the treated knee
6. Rapidly progressing osteoarthritis (RPOA)
7. Prior cartilage transplants in the index knee
8. Subjects who are actively treated with oral anticoagulants or heparin therapy (treatment such as low dose Aspirin and Plavix are allowed)
9. Current therapy with any immunosuppressive therapy, including corticosteroids (\> 5mg/day of prednisone)
10. Any method of medical marijuana use containing THC or CBD, including smoke or vaporized spray inhalation, pills or liquids, edible foods, topical applications, etc.
11. Clinically significant intercurrent illness, medical condition, non-knee pain, or medical history that could jeopardize the patient safety, limit participation, or compromise interpretation of data derived from the patient; this includes neurological or mental illness, human immunodeficiency virus, fibromyalgia, complex regional pain syndrome, or any active infection - including hepatitis B or C
12. Active alcohol or substance use disorder, or any other reason that would make it unlikely for the patient to comply with study procedures
13. Females who are lactating or pregnant (positive pregnancy test for females of childbearing potential at screening Females of childbearing potential must be willing to use an acceptable method of contraception from screening up until 90 days after study drug injection administration Acceptable methods of contraception include abstinence, female subject/partner's use of hormonal contraceptive (oral, patch, injectable, depot, or vaginal) in conjunction with a barrier method (e.g., diaphragm, cervical cap, condom, spermicide, or sponge), or female subject/partner's use of an implantable device (implantable rod or intrauterine device)
14. Subject has known allergy to any components of BRC-OA
15. Subject has received an investigational product within 3 months before screening
16. Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome of the patient

Where this trial is running

Baltimore, Maryland and 5 other locations

• LifeBridge Health — Baltimore, Maryland, United States (Not_yet_recruiting)
• The Osteoporosis & Clinical Trials Center — Hagerstown, Maryland, United States (Not_yet_recruiting)
• MD Medical Research — Oxon Hill, Maryland, United States (Recruiting)
• Northwell Health — New York, New York, United States (Not_yet_recruiting)
• University Orthopedics Center — Altoona, Pennsylvania, United States (Not_yet_recruiting)
• University Orthopedics Center — State College, Pennsylvania, United States (Not_yet_recruiting)

Study contacts

• Study coordinator: Molly Saunders

Conditions Osteoarthritis of Knee; Pain Treatment in Osteoarthritis of the Knee