NCT06040957 Bone Marrow Versus Adipose Tissue as a Cell Source for Infiltrative Treatment of Knee Osteoarthritis
| NCT ID | NCT06040957 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 204 participants |
| Start Date | 2024-01-08 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 204 participants in total. It began in 2024-01-08 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The MAST-GR study is a randomized controlled interventional trial with parallel treatment arms and 1:1 allocation The primary objective of the study is to compare the safety and efficacy of a single intra-articular infiltration of Bone marrow aspirate concentrate (BMAC) with one of minimally manipulated adipose tissue (MM-AT) so as to determine the most effective cellular product in treating patients with knee osteoarthritis (OA). The secondary objective is to demonstrate whether intra-articular infiltration of BMAC or MM-AT can induce disease-modifying effects in knee OA by imaging and biological assessments on peripheral blood. The tertiary objective of the study is to identify factors that influence the clinical response to treatment (baseline characteristics of patients, biological characteristics of the treated knee, characteristics of cellular products, BMAC and MM-AT).
Eligibility 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.
Contact & Investigator
Luca Andriolo, MD
PRINCIPAL INVESTIGATOR
Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica
Frequently Asked Questions
Who can join the NCT06040957 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06040957 currently recruiting?
Yes, NCT06040957 is actively recruiting participants. Contact the research team at luca.andriolo@ior.it for enrollment information.
Where is the NCT06040957 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06040957 clinical trial?
NCT06040957 is sponsored by Istituto Ortopedico Rizzoli. The principal investigator is Luca Andriolo, MD at Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica. The trial plans to enroll 204 participants.