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Compares treatment options for Knee Osteoarthritis
Official title Bone Marrow Versus Adipose Tissue as a Cell Source for Infiltrative Treatment of Knee Osteoarthritis
ClinicalTrials.gov ID: NCT06040957
What this study is testing
What is Bone marrow aspirate concentrate injection?
Bone marrow aspirate concentrate injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for knee osteoarthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75
You may be able to join if
- 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;
You likely can't join if
- Patients unable to express consent;
- Patients aged \ to 75 years;
- Patients with axial deviations \> 5°;
- 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);
See the full eligibility criteria
- 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.
- Patients unable to express consent;
- Patients aged \ to 75 years;
- Patients with axial deviations \> 5°;
- 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 malignant neoplasms;
- Patients with uncompensated systemic diseases (rheumatic diseases, metabolic disorders such as diabetes and thyroid diseases);
- Patients with infectious diseases;
- Patients with histories of alcohol or drug abuse;
- Patients who are pregnant;
- Patients with allergies to anesthetics used in the procedure.
The study team makes the final eligibility decision.
Where it's taking place
- Bologna, Italy
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bologna, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.