Knee OsteoarthritisNCT06040957
Bone Marrow Versus Adipose Tissue as a Cell Source for Infiltrative Treatment of Knee Osteoarthritis
A study testing Bone marrow aspirate concentrate injection and intra-articular injection of Minimally manipulated adipose tissue in people with Knee Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Bone marrow aspirate concentrate injection and intra-articular injection of Minimally manipulated adipose tissue
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- Patients unable to express consent;
- Patients aged < to 40 and > 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);
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Ortopedico Rizzoli
Bologna, 40136
Luca Andriolo, MD, 6366567 ext. 051, luca.andriolo@ior.it
Roberta Licciardi, MSc, 6366567 ext. 051, roberta.licciardi@ior.it
About this study
Official title: Bone Marrow vs Adipose Tissue as a Cell Source for Infiltrative Treatment of Knee Osteoarthritis: Randomized Clinical Trial
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).
Read more
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).
Read the detailed description
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Bone marrow aspirate concentrate injection, intra-articular injection of Minimally manipulated adipose tissue
- Keywords
- bone marrow aspirate concentrate, minimally manipulated adipose tissue, BMAC, MM-AT, intra-articular injection, knee injection, mesenchymal stromal cells, Randomized controlled trial, cellular orthobiological products
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow aspirate concentrate injectionBiological
single intra-articular injection of Bone Marrow aspirate concentrate derived from the patient's iliac crest
intra-articular injection of Minimally manipulated adipose tissueBiological
single intra-articular injection of Minimally manipulated adipose tissue derived from the patient's abdominal adipose tissue
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Biological: Bone marrow aspirate concentrate injection |
| 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) Receives: Biological: intra-articular injection of Minimally manipulated adipose tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months follow-up
Secondary outcomes (13)
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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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.
Measured: baseline, 2 months, 6 months, 12 months follow-up
Objective parameters- Range of Motion
Evaluation of the Range of Motion for comparative analysis.
Measured: baseline, 2 months, 6 months, 12 months follow-up
Objective parameters - Circumferences
Bilateral trans- and supra- patellar circumferences measurement for comparative analysis
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: baseline, 2 months, 6 months, 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start8 Jan 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized trial with 1:1 allocation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Andriolo, MD, Principal investigator, Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040957
- Sponsor's protocol ID
- MAST-GR
- Status last verified
- Feb 2026
- First submitted
- 9 Aug 2023
- Last updated
- 20 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will be able to share a subset of aggregated data, wich will not allow for the identification of participants
Publications
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.
PubMed 32118081Basile 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.
PubMed 36627953Boffa 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.
PubMed 32713185Boffa 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.
PubMed 34767030Cai X, Yuan S, Zeng Y, Wang C, Yu N, Ding C. New Trends in Pharmacological Treatments for Osteoarthritis. Front Pharmacol. 2021 Apr 15;12:645842. doi: 10.3389/fphar.2021.645842. eCollection 2021.
PubMed 33935742Caplan AI, Correa D. The MSC: an injury drugstore. Cell Stem Cell. 2011 Jul 8;9(1):11-5. doi: 10.1016/j.stem.2011.06.008.
PubMed 21726829Carelli S, Messaggio F, Canazza A, Hebda DM, Caremoli F, Latorre E, Grimoldi MG, Colli M, Bulfamante G, Tremolada C, Di Giulio AM, Gorio A. Characteristics and Properties of Mesenchymal Stem Cells Derived From Microfragmented Adipose Tissue. Cell Transplant. 2015;24(7):1233-52. doi: 10.3727/096368914X681603. Epub 2014 May 6.
PubMed 24806078Cavallo C, Boffa A, Andriolo L, Silva S, Grigolo B, Zaffagnini S, Filardo G. Bone marrow concentrate injections for the treatment of osteoarthritis: evidence from preclinical findings to the clinical application. Int Orthop. 2021 Feb;45(2):525-538. doi: 10.1007/s00264-020-04703-w. Epub 2020 Jul 13.
PubMed 32661635Costa V, Carina V, Conigliaro A, Raimondi L, De Luca A, Bellavia D, Salamanna F, Setti S, Alessandro R, Fini M, Giavaresi G. miR-31-5p Is a LIPUS-Mechanosensitive MicroRNA that Targets HIF-1alpha Signaling and Cytoskeletal Proteins. Int J Mol Sci. 2019 Mar 28;20(7):1569. doi: 10.3390/ijms20071569.
PubMed 30925808Costa V, Lo Dico A, Rizzo A, Rajata F, Tripodi M, Alessandro R, Conigliaro A. MiR-675-5p supports hypoxia induced epithelial to mesenchymal transition in colon cancer cells. Oncotarget. 2017 Apr 11;8(15):24292-24302. doi: 10.18632/oncotarget.14464.
PubMed 28061476Costa V, Carina V, Raimondi L, De Luca A, Bellavia D, Conigliaro A, Salamanna F, Alessandro R, Fini M, Giavaresi G. MiR-33a Controls hMSCS Osteoblast Commitment Modulating the Yap/Taz Expression Through EGFR Signaling Regulation. Cells. 2019 Nov 22;8(12):1495. doi: 10.3390/cells8121495.
PubMed 31771093Costa V, Raimondi L, Conigliaro A, Salamanna F, Carina V, De Luca A, Bellavia D, Alessandro R, Fini M, Giavaresi G. Hypoxia-inducible factor 1Alpha may regulate the commitment of mesenchymal stromal cells toward angio-osteogenesis by mirna-675-5P. Cytotherapy. 2017 Dec;19(12):1412-1425. doi: 10.1016/j.jcyt.2017.09.007. Epub 2017 Oct 27.
PubMed 29111380Costa V, De Fine M, Carina V, Conigliaro A, Raimondi L, De Luca A, Bellavia D, Salamanna F, Alessandro R, Pignatti G, Fini M, Giavaresi G. How miR-31-5p and miR-33a-5p Regulates SP1/CX43 Expression in Osteoarthritis Disease: Preliminary Insights. Int J Mol Sci. 2021 Feb 28;22(5):2471. doi: 10.3390/ijms22052471.
PubMed 33671114Durand M, Komarova SV, Bhargava A, Trebec-Reynolds DP, Li K, Fiorino C, Maria O, Nabavi N, Manolson MF, Harrison RE, Dixon SJ, Sims SM, Mizianty MJ, Kurgan L, Haroun S, Boire G, de Fatima Lucena-Fernandes M, de Brum-Fernandes AJ. Monocytes from patients with osteoarthritis display increased osteoclastogenesis and bone resorption: the In Vitro Osteoclast Differentiation in Arthritis study. Arthritis Rheum. 2013 Jan;65(1):148-58. doi: 10.1002/art.37722.
PubMed 23044761Filardo G, Perdisa F, Roffi A, Marcacci M, Kon E. Stem cells in articular cartilage regeneration. J Orthop Surg Res. 2016 Apr 12;11:42. doi: 10.1186/s13018-016-0378-x.
PubMed 27072345
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow vs Adipose Tissue as a Cell Source for Infiltrative Treatment of Knee Osteoarthritis: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06040957
- Acronym / sponsor ID
- MAST-GR
- Conditions
- Knee Osteoarthritis
- Keywords
- bone marrow aspirate concentrate, minimally manipulated adipose tissue, BMAC, MM-AT, intra-articular injection, knee injection, mesenchymal stromal cells, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized trial with 1:1 allocation.
| Arm | Type | Receives |
|---|---|---|
| single intra-articular injection of BMAC | Experimental | Biological: Bone marrow aspirate concentrate injectionPatients 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 | Biological: intra-articular injection of Minimally manipulated adipose tissuePatients randomized in this group will undergo single knee intra-articular injection of minimally manipulated adipose tissue (MM-AT) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (12 listed)
- Patients unable to express consent;
- Patients aged < to 40 and > 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone marrow aspirate concentrate injectionsingle intra-articular injection of Bone Marrow aspirate concentrate derived from the patient's iliac crest | Biological | single intra-articular injection of BMAC |
| intra-articular injection of Minimally manipulated adipose tissuesingle intra-articular injection of Minimally manipulated adipose tissue derived from the patient's abdominal adipose tissue | Biological | single intra-articular injection of MM-AT |
Primary outcome
Western Ontario and McMaster University Osteoarthritis index (WOMAC) - Pain subscale
Time frame: 6 months follow-up
It is a pathology-specific questionnaire used for the assessment of referred pain at the knee joint level in patients with OA
13 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: baseline, 2 months, 6 months, 12 months follow-up
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: baseline, 2 months, 6 months, 12 months follow-up
Visual Analogue Scale (VAS)
Time frame: baseline, 2 months, 6 months, 12 months follow-up
EuroQol Visual Analogue Scale (EQ-VAS)
Time frame: baseline, 2 months, 6 months, 12 months follow-up
Tegner Activity Level Scale
Time frame: baseline, 2 months, 6 months, 12 months follow-up
Objective parameters- Range of Motion
Time frame: baseline, 2 months, 6 months, 12 months follow-up
Objective parameters - Circumferences
Time frame: baseline, 2 months, 6 months, 12 months follow-up
Patient Acceptable Symptom State (PASS)
Time frame: baseline, 2 months, 6 months, 12 months follow-up
Minimally Clinical Important Difference (MCID)
Time frame: baseline, 2 months, 6 months, 12 months follow-up
Expectations about the effectiveness of the treatment
Time frame: baseline
Kellgren-Lawrence score
Time frame: baseline, 12 months follow-up
3 Tesla Nuclear Magnetic Resonance Imaging (3T MRI)
Time frame: baseline, 12 months follow-up
Analysis of circulating micro RNAs
Time frame: baseline, 2 months, 6 months, 12 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Background: PubMed 32118081Anz 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.
- Background: PubMed 36627953Basile 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.
- Background: PubMed 32713185Boffa 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.
- Background: PubMed 34767030Boffa 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.
- Background: PubMed 33935742Cai X, Yuan S, Zeng Y, Wang C, Yu N, Ding C. New Trends in Pharmacological Treatments for Osteoarthritis. Front Pharmacol. 2021 Apr 15;12:645842. doi: 10.3389/fphar.2021.645842. eCollection 2021.
- Background: PubMed 21726829Caplan AI, Correa D. The MSC: an injury drugstore. Cell Stem Cell. 2011 Jul 8;9(1):11-5. doi: 10.1016/j.stem.2011.06.008.
- Background: PubMed 24806078Carelli S, Messaggio F, Canazza A, Hebda DM, Caremoli F, Latorre E, Grimoldi MG, Colli M, Bulfamante G, Tremolada C, Di Giulio AM, Gorio A. Characteristics and Properties of Mesenchymal Stem Cells Derived From Microfragmented Adipose Tissue. Cell Transplant. 2015;24(7):1233-52. doi: 10.3727/096368914X681603. Epub 2014 May 6.
- Background: PubMed 32661635Cavallo C, Boffa A, Andriolo L, Silva S, Grigolo B, Zaffagnini S, Filardo G. Bone marrow concentrate injections for the treatment of osteoarthritis: evidence from preclinical findings to the clinical application. Int Orthop. 2021 Feb;45(2):525-538. doi: 10.1007/s00264-020-04703-w. Epub 2020 Jul 13.
- Background: PubMed 30925808Costa V, Carina V, Conigliaro A, Raimondi L, De Luca A, Bellavia D, Salamanna F, Setti S, Alessandro R, Fini M, Giavaresi G. miR-31-5p Is a LIPUS-Mechanosensitive MicroRNA that Targets HIF-1alpha Signaling and Cytoskeletal Proteins. Int J Mol Sci. 2019 Mar 28;20(7):1569. doi: 10.3390/ijms20071569.
- Background: PubMed 28061476Costa V, Lo Dico A, Rizzo A, Rajata F, Tripodi M, Alessandro R, Conigliaro A. MiR-675-5p supports hypoxia induced epithelial to mesenchymal transition in colon cancer cells. Oncotarget. 2017 Apr 11;8(15):24292-24302. doi: 10.18632/oncotarget.14464.
- Background: PubMed 31771093Costa V, Carina V, Raimondi L, De Luca A, Bellavia D, Conigliaro A, Salamanna F, Alessandro R, Fini M, Giavaresi G. MiR-33a Controls hMSCS Osteoblast Commitment Modulating the Yap/Taz Expression Through EGFR Signaling Regulation. Cells. 2019 Nov 22;8(12):1495. doi: 10.3390/cells8121495.
- Background: PubMed 29111380Costa V, Raimondi L, Conigliaro A, Salamanna F, Carina V, De Luca A, Bellavia D, Alessandro R, Fini M, Giavaresi G. Hypoxia-inducible factor 1Alpha may regulate the commitment of mesenchymal stromal cells toward angio-osteogenesis by mirna-675-5P. Cytotherapy. 2017 Dec;19(12):1412-1425. doi: 10.1016/j.jcyt.2017.09.007. Epub 2017 Oct 27.
- Individual participant dataSharing planned: No. We will be able to share a subset of aggregated data, wich will not allow for the identification of participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luca Andriolo, MD principal investigator
Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone marrow aspirate concentrate injection and intra-articular injection of Minimally manipulated adipose tissue in people with Knee Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luca Andriolo, MD (6366567 ext. 051, luca.andriolo@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster University Osteoarthritis index (WOMAC) - Pain subscale (time frame: 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06040957, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.