Treatment for early-stage osteonecrosis using bone marrow aspirate
Autologous Bone Marrow Aspirate Concentrate for the Treatment of Osteonecrosis of the Femoral Head
This study is testing whether a treatment using bone marrow from patients can help people with early-stage osteonecrosis of the hip feel better and avoid needing joint replacement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 192 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 10 sites (Los Angeles, California and 9 other locations) |
| Trial ID | NCT06123481 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of autologous bone marrow aspirate concentrate (BMAC) combined with core decompression in treating early-stage osteonecrosis of the femoral head. It aims to compare clinical and radiological outcomes between patients receiving BMAC and those undergoing core decompression alone. The study will assess the progression of osteonecrosis and the time taken for any radiological changes to occur. Participants will include individuals diagnosed with non-traumatic osteonecrosis at stages 1 or 2, with a focus on preserving joint function and delaying the need for joint replacement.
Who should consider this trial
Good fit: Ideal candidates are individuals with non-traumatic osteonecrosis of the femoral head at stages 1 or 2.
Not a fit: Patients with conditions such as sickle cell disease, major trauma, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive option for patients with early-stage osteonecrosis, potentially preserving their hip joint and improving quality of life.
How similar studies have performed: Other studies have shown promise in using cell-based treatments for osteonecrosis, but this specific approach is still being rigorously evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Participants who have non-traumatic osteonecrosis of the femoral head * Only participants who have Stage 1 or 2 osteonecrosis as assessed by the 2019 ARCO Staging System * No evidence of subchondral fracture * All osteonecrotic lesion sizes * All major risk factors (e.g. corticosteroids, alcohol, organ recipient) except for those listed in the exclusion criteria * Participants diagnosed who have femoral head osteonecrosis for which no risk factor has yet to be identified * Participants will include all ethnicities and races * Be able and willing to participate in study and return for postoperative visits Exclusion Criteria * Participants who have: * Sickle Cell disease * Major trauma * Post-irradiation ON * Gaucher Disease * Juvenile form: Legg-Calve-Perthes Disease * Juvenile form: Spontaneous ON of the hip * Pregnant or breastfeeding * Vulnerable population; i.e., prisoners and institutionalized individuals * Participant is unable to undergo an MRI * Participants who have evidence of a subchondral fracture * Prior history of hip surgery, more extensive than hip arthroscopy
Where this trial is running
Los Angeles, California and 9 other locations
- University of Southern California — Los Angeles, California, United States (Recruiting)
- Stanford University — Stanford, California, United States (Recruiting)
- Sinai Hospital of Baltimore — Baltimore, Maryland, United States (Recruiting)
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- NYU Langone Health Orthopedic Hospital — New York, New York, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Lynne C Jones, PhD — Johns Hopkins University
- Study coordinator: Lynne C Jones, PhD
- Email: ljones3@jhmi.edu
- Phone: (410) 550-4001
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.