Bone Marrow Versus Adipose Tissue as a Cell Source for Infiltrative Treatment of Knee Osteoarthritis
Key facts
- Who runs it
- Istituto Ortopedico Rizzoli
- Where
- Bologna, ItalySee the site
- Trial code
- Status
- Recruiting
- People taking part
- 204 people, planned
- Started
- 8 Jan 2024
- Expected to end
- Jan 2027
- Type of study
- Interventional, 2 groups
- Treatments tested
- Bone marrow aspirate concentrate injection
- intra-articular injection of Minimally manipulated adipose tissue
- Record updated
- 20 February 2026
Who can take part
- Age
- 40 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- Patients with symptomatic unilateral knee OA with:
- Men or women aged 40 to 75 years
- Signs and symptoms of OA with a clinical history of gonalgia or swelling for at least 6 months
- Radiographic signs of OA (Kellgren-Lawrence grade 1-4)
- No benefit after at least 4 months of conservative treatment
- Ability and consent of patients to actively participate in clinical and radiological (rx and MRI) follow-up
- Signing of informed consent
Who cannot take part
- Patients who have suffered trauma or undergone intra-articular infiltration of other substance in the previous 6 months
- Patients who have undergone knee surgery in the previous 12 months
- Patients with concomitant knee injuries causing joint pain or swelling (-focal full-thickness osteochondral defects, acute meniscal injuries)
- Patients with histories of alcohol or drug abuse
- Patients with malignant neoplasms
- Patients with uncompensated systemic diseases (rheumatic diseases, metabolic disorders such as diabetes and thyroid diseases)
- Patients with infectious diseases
- Patients with allergies to anesthetics used in the procedure
- Patients aged < to 40 and > to 75 years
- Patients unable to express consent
- Patients with axial deviations > 5°
- Patients who are pregnant
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 75 years old?
Where in Italy
- Istituto Ortopedico RizzoliBologna, ItalyContact: Luca Andriolo, MDTaking people
About the trial
What the trial wants to find out
The MAST-GR study is a randomized controlled interventional trial with parallel treatment arms and 1:1 allocation
Read full original descriptionShow less
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).
The 2 groups in the trial
- single intra-articular injection of BMACTreatment being tested
Patients randomized in this group will undergo single knee intra-articular injection of bone marrow aspirate concentrate (BMAC)
Treatment: Bone marrow aspirate concentrate injection
- single intra-articular injection of MM-ATTreatment being tested
Patients randomized in this group will undergo single knee intra-articular injection of minimally manipulated adipose tissue (MM-AT)
Treatment: intra-articular injection of Minimally manipulated adipose tissue
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Bone Marrow vs Adipose Tissue as a Cell Source for Infiltrative Treatment of Knee Osteoarthritis: Randomized Clinical Trial
- Fit questions
- Built from NCT06040957, who can take part
- Record updated
- 20 February 2026