Bone Marrow Versus Adipose Tissue as a Cell Source for Infiltrative Treatment of Knee Osteoarthritis

Recruiting now · Not applicable

Conditions studied: Knee Osteoarthritis

In brief

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).

Key facts

Study ID

NCT06040957

Run by

Istituto Ortopedico Rizzoli

People needed

204

Starts

2024-01-08

Expected to finish

2027-01-01

Last updated by the study team

2026-02-20

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with symptomatic unilateral knee OA with:
• Men or women aged 40 to 75 years;
• Signs and symptoms of OA with a clinical history of gonalgia or swelling for at least 6 months;
• Radiographic signs of OA (Kellgren-Lawrence grade 1-4);
• No benefit after at least 4 months of conservative treatment;
• Ability and consent of patients to actively participate in clinical and radiological (rx and MRI) follow-up;
• Signing of informed consent.

You may not qualify if…

• Patients unable to express consent;
• Patients aged < to 40 and > to 75 years;
• Patients with axial deviations > 5°;
• Patients who have suffered trauma or undergone intra-articular infiltration of other substance in the previous 6 months;
• Patients who have undergone knee surgery in the previous 12 months;
• Patients with concomitant knee injuries causing joint pain or swelling (-focal full-thickness osteochondral defects, acute meniscal injuries);
• Patients with malignant neoplasms;
• Patients with uncompensated systemic diseases (rheumatic diseases, metabolic disorders such as diabetes and thyroid diseases);
• Patients with infectious diseases;
• Patients with histories of alcohol or drug abuse;
• Patients who are pregnant;
• Patients with allergies to anesthetics used in the procedure.

Where it is running

• Istituto Ortopedico Rizzoli — Bologna, Italy (enrolling)

Full record on ClinicalTrials.gov

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