Actively Recruiting

Phase Not Applicable
Age: 40Years - 75Years
All Genders
NCT06040957

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

Led by Istituto Ortopedico Rizzoli · Updated on 2026-02-20

204

Participants Needed

1

Research Sites

155 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 40Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men or women aged 40 to 75 years
  • Symptomatic unilateral knee osteoarthritis with pain or swelling for at least 6 months
  • Radiographic evidence of knee osteoarthritis (Kellgren-Lawrence grade 1-4)
  • No improvement after at least 4 months of conservative treatment
  • Willingness and ability to participate in clinical and imaging follow-up (X-rays and MRI)
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Age below 40 or above 75 years
  • Axial knee deviations greater than 5 degrees
  • Trauma or intra-articular injection of other substances in the past 6 months
  • Knee surgery within the past 12 months
  • Other knee injuries causing pain or swelling, such as full-thickness osteochondral defects or acute meniscal injuries
  • Malignant tumors
  • Uncontrolled systemic diseases including rheumatic, metabolic (diabetes, thyroid), or infectious diseases
  • History of alcohol or drug abuse
  • Pregnancy
  • Allergy to anesthetics used in the procedure

AI-Screening

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Trial Site Locations

Total: 1 location

1

Istituto Ortopedico Rizzoli

Bologna, Italy, 40136

Actively Recruiting

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Research Team

L

Luca Andriolo, MD

CONTACT

R

Roberta Licciardi, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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