Comparing bone marrow and fat tissue injections for knee osteoarthritis treatment
Bone Marrow vs Adipose Tissue as a Cell Source for Infiltrative Treatment of Knee Osteoarthritis: Randomized Clinical Trial
This study is testing whether injections of bone marrow or fat tissue can help people with knee osteoarthritis feel better and improve their condition over a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06040957 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of two different cellular products, bone marrow aspirate concentrate (BMAC) and minimally manipulated adipose tissue (MM-AT), for treating knee osteoarthritis. Patients with symptomatic unilateral knee OA will be randomly assigned to receive either BMAC or MM-AT through a single intra-articular injection. The study will assess clinical outcomes and potential disease-modifying effects over a 12-month follow-up period using imaging and biological assessments. Additionally, factors influencing treatment response will be analyzed to better understand the efficacy of these interventions.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 40 to 75 with symptomatic unilateral knee osteoarthritis who have not benefited from conservative treatments.
Not a fit: Patients with significant knee deformities, recent knee surgeries, or other knee injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from knee osteoarthritis.
How similar studies have performed: Other studies have shown promise in using similar cellular therapies for joint conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients with symptomatic unilateral knee OA with: 1. Men or women aged 40 to 75 years; 2. Signs and symptoms of OA with a clinical history of gonalgia or swelling for at least 6 months; 3. Radiographic signs of OA (Kellgren-Lawrence grade 1-4); 4. No benefit after at least 4 months of conservative treatment; 5. Ability and consent of patients to actively participate in clinical and radiological (rx and MRI) follow-up; 6. Signing of informed consent. Exclusion Criteria: 1. Patients unable to express consent; 2. Patients aged \< to 40 and \> to 75 years; 3. Patients with axial deviations \> 5°; 4. Patients who have suffered trauma or undergone intra-articular infiltration of other substance in the previous 6 months; 5. Patients who have undergone knee surgery in the previous 12 months; 6. Patients with concomitant knee injuries causing joint pain or swelling (-focal full-thickness osteochondral defects, acute meniscal injuries); 7. Patients with malignant neoplasms; 8. Patients with uncompensated systemic diseases (rheumatic diseases, metabolic disorders such as diabetes and thyroid diseases); 9. Patients with infectious diseases; 10. Patients with histories of alcohol or drug abuse; 11. Patients who are pregnant; 12. Patients with allergies to anesthetics used in the procedure.
Where this trial is running
Bologna
- Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Luca Andriolo, MD — Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica
- Study coordinator: Luca Andriolo, MD
- Email: luca.andriolo@ior.it
- Phone: 6366567
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.