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

NCT ID: NCT06040957

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-08
• Study Completion Date: 2027-01-31

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).

Detailed Description

Patients with symptomatic unilateral knee OA will be included in a randomized controlled Trial (RCT), in which one group of patients will be treated with 1 intra-articular infiltration of BMAC, and one group will be treated with 1 intra-articular infiltration of MM-AT. A total of 204 patients will be included and will undergo infiltrative treatment after collecting informed consent for study participation and master data. Patients will be clinically evaluated at 0-2-6-12 months follow-up. Possible disease-modifying effects of the two cell products will be investigated by analysis on peripheral blood at 0-2-6-12 months follow-up and by evaluation of radiographic and magnetic resonance imaging (MRI) at 0 and 12 months follow-up. In addition, characterization of the portion of BMAC and MM-AT remaining from treatment will be carried out, as well as baseline assessment of peripheral blood on all patients, and synovial fluid and synovial membrane, where possible, to analyze their influence on clinical outcome.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

single intra-articular injection of BMAC

Patients randomized in this group will undergo single knee intra-articular injection of bone marrow aspirate concentrate (BMAC)

Group Type: EXPERIMENTAL

Bone marrow aspirate concentrate injection

Intervention Type: BIOLOGICAL

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

single intra-articular injection of MM-AT

Patients randomized in this group will undergo single knee intra-articular injection of minimally manipulated adipose tissue (MM-AT)

Group Type: EXPERIMENTAL

intra-articular injection of Minimally manipulated adipose tissue

Intervention Type: BIOLOGICAL

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

Interventions

Bone marrow aspirate concentrate injection

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

Intervention Type: BIOLOGICAL

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

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luca Andriolo, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica

Locations

Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Luca Andriolo, MD

Role: CONTACT

luca.andriolo@ior.it

6366567 ext. 051

Roberta Licciardi, MSc

Role: CONTACT

roberta.licciardi@ior.it

6366567 ext. 051

Facility Contacts

Luca Andriolo, MD

Role: primary

luca.andriolo@ior.it

6366567 ext. 051

Roberta Licciardi, MSc

Role: backup

roberta.licciardi@ior.it

6366567 ext. 051

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Other Identifiers

MAST-GR

Identifier Type: -

Identifier Source: org_study_id