RecruitingNot ApplicableNCT06040957

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

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


Sponsor

Istituto Ortopedico Rizzoli

Enrollment

204 participants

Start Date

Jan 8, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Bone marrow aspirate concentrate injection and a biological treatment called intra-articular injection of Minimally manipulated adipose tissue for people with knee osteoarthritis. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBone marrow aspirate concentrate injection

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

BIOLOGICALintra-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

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NCT06040957


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