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

NCT06040957 · tracked via the Priya Life Science Italy tracker

Sponsor

Istituto Ortopedico Rizzoli

Phase

Not applicable

Started

2024-01-08

Last updated

2026-02-20

Condition(s) studied

Knee Osteoarthritis

Investigational drug(s) / intervention(s)

Bone marrow aspirate concentrate injection →intra-articular injection of Minimally manipulated adipose tissue

Bone marrow aspirate concentrate injection: single intra-articular injection of Bone Marrow aspirate concentrate derived from the patient's iliac crest

intra-articular injection of Minimally manipulated adipose tissue: single intra-articular injection of Minimally manipulated adipose tissue derived from the patient's abdominal adipose tissue

Study 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

Sex

ALL

Min age

40 Years

Max age

75 Years

Healthy volunteers

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.

Primary outcome measure(s)

Western Ontario and McMaster University Osteoarthritis index (WOMAC) - Pain subscale — 6 months follow-up
It is a pathology-specific questionnaire used for the assessment of referred pain at the knee joint level in patients with OA

Trial sites (1)

Facility	City	Region	Status
Istituto Ortopedico Rizzoli	Bologna	Italy	Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06040957 on ClinicalTrials.gov ↗ ← All trials in Italy