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RECRUITING
NCT06040957
NA

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

Sponsor: Istituto Ortopedico Rizzoli

View on ClinicalTrials.gov

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).

Official title: Bone Marrow vs Adipose Tissue as a Cell Source for Infiltrative Treatment of Knee Osteoarthritis: Randomized Clinical Trial

Key Details

Gender

All

Age Range

40 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

204

Start Date

2024-01-08

Completion Date

2027-01

Last Updated

2026-02-20

Healthy Volunteers

No

Interventions

BIOLOGICAL

Bone marrow aspirate concentrate injection

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

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

Locations (1)

Istituto Ortopedico Rizzoli

Bologna, Italy