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

NCT06040957 | Recruiting

• 1 other identifier: MAST-GR
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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).

Conditions

Knee Osteoarthritis

Keywords

bone marrow aspirate concentrate; minimally manipulated adipose tissue; BMAC; MM-AT; intra-articular injection; knee injection; mesenchymal stromal cells; Randomized controlled trial; cellular orthobiological products

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster University Osteoarthritis index (WOMAC) - Pain subscale

  It is a pathology-specific questionnaire used for the assessment of referred pain at the knee joint level in patients with OA

  6 months follow-up

Secondary Outcomes (13)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  baseline, 2 months, 6 months, 12 months follow-up

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  baseline, 2 months, 6 months, 12 months follow-up

• Visual Analogue Scale (VAS)

  baseline, 2 months, 6 months, 12 months follow-up

• EuroQol Visual Analogue Scale (EQ-VAS)

  baseline, 2 months, 6 months, 12 months follow-up

• Tegner Activity Level Scale

  baseline, 2 months, 6 months, 12 months follow-up

Study Arms (2)

single intra-articular injection of BMAC

EXPERIMENTAL

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

Biological: Bone marrow aspirate concentrate injection

single intra-articular injection of MM-AT

EXPERIMENTAL

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

Biological: intra-articular injection of Minimally manipulated adipose tissue

Interventions

intra-articular injection of Minimally manipulated adipose tissue BIOLOGICAL

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

single intra-articular injection of MM-AT

Bone marrow aspirate concentrate injection BIOLOGICAL

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

single intra-articular injection of BMAC

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Related Publications (35)

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  PMID: 40306987 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Luca Andriolo, MD

  Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Andriolo, MD

CONTACT

6366567; luca.andriolo@ior.it

Roberta Licciardi, MSc

CONTACT

6366567; roberta.licciardi@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To ensure the blinding of the health care personnel who will perform the checks (single-blind), follow-up visits will be performed by physicians not involved in the treatment procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized trial with 1:1 allocation.

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: September 18, 2023
• Study Start: January 8, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)