MedTrace Logo

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

NCT06040957 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2026-02-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Istituto Ortopedico Rizzoli

    lead OTHER

Principal Investigators

  • Luca Andriolo, MD · Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-08
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06040957 on ClinicalTrials.gov