Treatment for knee osteoarthritis using bone marrow aspirate concentrate
Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis
NA · University of California, San Diego · NCT04716803
This study is testing whether a treatment using concentrated bone marrow can help people with moderate to severe knee osteoarthritis feel less pain and improve their joint health before they have knee replacement surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | All |
| Sponsor | University of California, San Diego (other) |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT04716803 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the safety and effectiveness of bone marrow aspirate concentrate (BMAC) in patients with moderate to severe knee osteoarthritis who are scheduled for total knee replacement. Patients will have bone marrow extracted from their pelvic region, concentrated using the Angel System, and then delivered back to the knee arthroscopically. The study will monitor adverse events and assess healing through physical exams and standardized questionnaires. The goal is to determine if BMAC can improve joint structure and alleviate pain.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 45-75 with Kellgren Lawrence grade IV osteoarthritis and persistent knee pain unresponsive to standard treatments.
Not a fit: Patients with mild osteoarthritis or those who do not require total knee arthroscopy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive alternative to total knee replacement and improve joint health for patients with knee osteoarthritis.
How similar studies have performed: Other studies have shown promising results with stem cell-based therapies for osteoarthritis, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Kellgren Lawrence radiographic grade IV 2. Need for a total knee arthroscopy by the patients primary care provider/or orthopedist. 3. Persistent pain in target knee that is unresponsive to standard of care including acetametaphine, non-steroidal anti-inflammatory drugs, physical therapy and/or intraarticular corticosteroids and/or hyaluronic acid preparations. 4. Males or females aged 45-75. Exclusion Criteria: \-
Where this trial is running
La Jolla, California
- University of California San Diego Koman Outpatient Pavilion — La Jolla, California, United States (RECRUITING)
Study contacts
- Study coordinator: Kenneth Kalunian, MD
- Email: kkalunian@health.ucsd.edu
- Phone: 858-246-2381
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.
Conditions: Osteo Arthritis Knee, moderate to severe knee osteoarthritis, total knee replacement, bone marrow, stem cell-based therapy, arthroscopy