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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).
Patients with symptomatic unilateral knee OA will be included in a randomized controlled Trial (RCT), in which one group of patients will be treated with 1 intra-articular infiltration of BMAC, and one group will be treated with 1 intra-articular infiltration of MM-AT. A total of 204 patients will be included and will undergo infiltrative treatment after collecting informed consent for study participation and master data. Patients will be clinically evaluated at 0-2-6-12 months follow-up. Possible disease-modifying effects of the two cell products will be investigated by analysis on peripheral blood at 0-2-6-12 months follow-up and by evaluation of radiographic and magnetic resonance imaging (MRI) at 0 and 12 months follow-up. In addition, characterization of the portion of BMAC and MM-AT remaining from treatment will be carried out, as well as baseline assessment of peripheral blood on all patients, and synovial fluid and synovial membrane, where possible, to analyze their influence on clinical outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single intra-articular injection of BMAC | Experimental | Patients randomized in this group will undergo single knee intra-articular injection of bone marrow aspirate concentrate (BMAC) |
|
| single intra-articular injection of MM-AT | Experimental | Patients randomized in this group will undergo single knee intra-articular injection of minimally manipulated adipose tissue (MM-AT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone marrow aspirate concentrate injection | Biological | single intra-articular injection of Bone Marrow aspirate concentrate derived from the patient's iliac crest |
|
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster University Osteoarthritis index (WOMAC) - Pain subscale | It is a pathology-specific questionnaire used for the assessment of referred pain at the knee joint level in patients with OA | 6 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | It's a standardized and widely used questionnaire to assess the condition of patients with osteoarthritis of the knee and includes assessment of pain, stiffness, and physical function of the joints. It can be administered to the patient. It measures 5 items for pain (range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68) that mainly relate to activities of daily living (e.g., getting up from a sitting position, bending over, going up and down stairs etc.); The score is then normalized on a 0-100 scale. Higher values indicate a worse outcome |
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Inclusion Criteria:
Patients with symptomatic unilateral knee OA with:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luca Andriolo, MD | Contact | 6366567 | 051 | luca.andriolo@ior.it |
| Roberta Licciardi, MSc | Contact | 6366567 | 051 | roberta.licciardi@ior.it |
| Name | Affiliation | Role |
|---|---|---|
| Luca Andriolo, MD | Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Recruiting | Bologna | 40136 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32118081 | Background | Anz AW, Hubbard R, Rendos NK, Everts PA, Andrews JR, Hackel JG. Bone Marrow Aspirate Concentrate Is Equivalent to Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis at 1 Year: A Prospective, Randomized Trial. Orthop J Sports Med. 2020 Feb 18;8(2):2325967119900958. doi: 10.1177/2325967119900958. eCollection 2020 Feb. | |
| 36627953 |
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We will be able to share a subset of aggregated data, wich will not allow for the identification of participants
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This is a randomized trial with 1:1 allocation.
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To ensure the blinding of the health care personnel who will perform the checks (single-blind), follow-up visits will be performed by physicians not involved in the treatment procedures.
| intra-articular injection of Minimally manipulated adipose tissue | Biological | single intra-articular injection of Minimally manipulated adipose tissue derived from the patient's abdominal adipose tissue |
|
| baseline, 2 months, 6 months, 12 months follow-up |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathology. The questionnaire examines the following categories: symptoms, stiffness, pain, daily activities, sports and quality of life | baseline, 2 months, 6 months, 12 months follow-up |
| Visual Analogue Scale (VAS) | Visual analog scale consisting of a straight line segment (10 cm length), the ends of which correspond to "no pain" (0) and "the strongest pain imaginable" (10). | baseline, 2 months, 6 months, 12 months follow-up |
| EuroQol Visual Analogue Scale (EQ-VAS) | EQ-VAS is a visual analog scale that has a range of scores from 0 (worst imaginable health condition) to 100 (best imaginable health condition). | baseline, 2 months, 6 months, 12 months follow-up |
| Tegner Activity Level Scale | Tegner Activity Level Scale is a questionnaire to find out the patient's level of physical activity.All patients will indicate the type of sporting activity performed and its frequency. | baseline, 2 months, 6 months, 12 months follow-up |
| Objective parameters- Range of Motion | Evaluation of the Range of Motion for comparative analysis. | baseline, 2 months, 6 months, 12 months follow-up |
| Objective parameters - Circumferences | Bilateral trans- and supra- patellar circumferences measurement for comparative analysis | baseline, 2 months, 6 months, 12 months follow-up |
| Patient Acceptable Symptom State (PASS) | A tool to assess patient satisfaction in consideration of their current degree of pain, function, and daily activity. Patients can express if their state of health will be satisfying, answering "yes" or "no. | baseline, 2 months, 6 months, 12 months follow-up |
| Minimally Clinical Important Difference (MCID) | The patient should indicate the degree of perceived improvement after the infiltrative procedure. | baseline, 2 months, 6 months, 12 months follow-up |
| Expectations about the effectiveness of the treatment | The patient should indicate at baseline what clinical benefits he or she expects from the treatment according to the question, "What benefits do you expect to get as a result of the treatment you will undergo?" the patient can choose from one of the following items:Full recovery, Definitely better, Much better, Slightly better,No change | baseline |
| Kellgren-Lawrence score | The Kellgren Lawrence scale classifies knee OA into 4 grades of subsequent greater severity, the parameters used being reduced joint space and the presence of osteophytes | baseline, 12 months follow-up |
| 3 Tesla Nuclear Magnetic Resonance Imaging (3T MRI) | Sequences such as T2-weighted FSE, FS-3D SPGR, and T2 Mapping will be used to assess cartilage thickness and signal, the presence of cysts and subchondral edema, joint profile, the presence of osteophytes and their size, the status of the menisci, both medial and lateral, and the status of the synovium. | baseline, 12 months follow-up |
| Analysis of circulating micro RNAs | miRNAs, involved in OA progression, will be identified and quantified, including miR675-5p, miR-31-5p and miR-33a-5p | baseline, 2 months, 6 months, 12 months follow-up |
| Basile M, Rumi F, Palmeri M, Mattozzi I, Manzoli L, Mammucari M, Gigliotti S, Bernabei R, Cicchetti A. Il burden economico dell'inappropriatezza prescrittiva nella gestione dell'osteoartrite in Italia. Glob Reg Health Technol Assess. 2020 Dec 10;7:101-108. doi: 10.33393/grhta.2020.2130. eCollection 2020 Jan-Dec. Italian. |
| 32713185 | Background | Boffa A, Merli G, Andriolo L, Lattermann C, Salzmann GM, Filardo G. Synovial Fluid Biomarkers in Knee Osteoarthritis: A Systematic Review and Quantitative Evaluation Using BIPEDs Criteria. Cartilage. 2021 Dec;13(1_suppl):82S-103S. doi: 10.1177/1947603520942941. Epub 2020 Jul 25. |
| 34767030 | Background | Boffa A, Di Martino A, Andriolo L, De Filippis R, Poggi A, Kon E, Zaffagnini S, Filardo G. Bone marrow aspirate concentrate injections provide similar results versus viscosupplementation up to 24 months of follow-up in patients with symptomatic knee osteoarthritis. A randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2022 Dec;30(12):3958-3967. doi: 10.1007/s00167-021-06793-4. Epub 2021 Nov 12. |
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| 40306987 | Derived | Andriolo L, Veronesi F, Zanasi L, Costa V, Franceschini M, Miceli M, Spinnato P, Zaffagnini S, Giavaresi G, Filardo G. Adipose tissue-derived versus bone marrow-derived cell concentrates for the injective treatment of knee osteoarthritis: protocol of a prospective randomised controlled trial. BMJ Open. 2025 Apr 30;15(4):e092379. doi: 10.1136/bmjopen-2024-092379. |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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