Clinical trial NCT06040957: Bone Marrow Versus Adipose Tissue as a Cell Source for Infiltrative Treatment of Knee Osteoarthritis
Official title: Bone Marrow vs Adipose Tissue as a Cell Source for Infiltrative Treatment of Knee Osteoarthritis: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 204
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized trial with 1:1 allocation.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Western Ontario and McMaster University Osteoarthritis index (WOMAC) - Pain subscale
timeFrame: 6 months follow-up
Secondary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: baseline, 2 months, 6 months, 12 months follow-up
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: baseline, 2 months, 6 months, 12 months follow-up
measure: Visual Analogue Scale (VAS)
timeFrame: baseline, 2 months, 6 months, 12 months follow-up
measure: EuroQol Visual Analogue Scale (EQ-VAS)
timeFrame: baseline, 2 months, 6 months, 12 months follow-up
measure: Tegner Activity Level Scale
timeFrame: baseline, 2 months, 6 months, 12 months follow-up
measure: Objective parameters- Range of Motion
timeFrame: baseline, 2 months, 6 months, 12 months follow-up
measure: Objective parameters - Circumferences
timeFrame: baseline, 2 months, 6 months, 12 months follow-up
measure: Patient Acceptable Symptom State (PASS)
timeFrame: baseline, 2 months, 6 months, 12 months follow-up
measure: Minimally Clinical Important Difference (MCID)
timeFrame: baseline, 2 months, 6 months, 12 months follow-up
measure: Expectations about the effectiveness of the treatment
timeFrame: baseline
measure: Kellgren-Lawrence score
timeFrame: baseline, 12 months follow-up
measure: 3 Tesla Nuclear Magnetic Resonance Imaging (3T MRI)
timeFrame: baseline, 12 months follow-up
measure: Analysis of circulating micro RNAs
timeFrame: baseline, 2 months, 6 months, 12 months follow-up
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
affiliation: Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica
name: Luca Andriolo, MD
role: PRINCIPAL_INVESTIGATOR
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