xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06040957</url>
    </required_header>
    <id_info>
      <org_study_id>MAST-GR</org_study_id>
      <nct_id>NCT06040957</nct_id>
    </id_info>
    <brief_title>Bone Marrow Versus Adipose Tissue as a Cell Source for Infiltrative Treatment of Knee Osteoarthritis</brief_title>
    <official_title>Bone Marrow vs Adipose Tissue as a Cell Source for Infiltrative Treatment of Knee Osteoarthritis: Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istituto Ortopedico Rizzoli</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istituto Ortopedico Rizzoli</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The MAST-GR study is a randomized controlled interventional trial with parallel treatment&#xD;
        arms and 1:1 allocation&#xD;
  &#xD;
        The primary objective of the study is to compare the safety and efficacy of a single&#xD;
        intra-articular infiltration of Bone marrow aspirate concentrate (BMAC) with one of minimally&#xD;
        manipulated adipose tissue (MM-AT) so as to determine the most effective cellular product in&#xD;
        treating patients with knee osteoarthritis (OA).&#xD;
  &#xD;
        The secondary objective is to demonstrate whether intra-articular infiltration of BMAC or&#xD;
        MM-AT can induce disease-modifying effects in knee OA by imaging and biological assessments&#xD;
        on peripheral blood.&#xD;
  &#xD;
        The tertiary objective of the study is to identify factors that influence the clinical&#xD;
        response to treatment (baseline characteristics of patients, biological characteristics of&#xD;
        the treated knee, characteristics of cellular products, BMAC and MM-AT).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients with symptomatic unilateral knee OA will be included in a randomized controlled&#xD;
        Trial (RCT), in which one group of patients will be treated with 1 intra-articular&#xD;
        infiltration of BMAC, and one group will be treated with 1 intra-articular infiltration of&#xD;
        MM-AT. A total of 204 patients will be included and will undergo infiltrative treatment after&#xD;
        collecting informed consent for study participation and master data. Patients will be&#xD;
        clinically evaluated at 0-2-6-12 months follow-up. Possible disease-modifying effects of the&#xD;
        two cell products will be investigated by analysis on peripheral blood at 0-2-6-12 months&#xD;
        follow-up and by evaluation of radiographic and magnetic resonance imaging (MRI) at 0 and 12&#xD;
        months follow-up. In addition, characterization of the portion of BMAC and MM-AT remaining&#xD;
        from treatment will be carried out, as well as baseline assessment of peripheral blood on all&#xD;
        patients, and synovial fluid and synovial membrane, where possible, to analyze their&#xD;
        influence on clinical outcome.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">January 2027</completion_date>
    <primary_completion_date type="Anticipated">January 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>This is a randomized trial with 1:1 allocation.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>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.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Western Ontario and McMaster University Osteoarthritis index (WOMAC) - Pain subscale</measure>
      <time_frame>6 months follow-up</time_frame>
      <description>It is a pathology-specific questionnaire used for the assessment of referred pain at the knee joint level in patients with OA</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)</measure>
      <time_frame>baseline, 2 months, 6 months, 12 months follow-up</time_frame>
      <description>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.&#xD;
  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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
      <time_frame>baseline, 2 months, 6 months, 12 months follow-up</time_frame>
      <description>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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual Analogue Scale (VAS)</measure>
      <time_frame>baseline, 2 months, 6 months, 12 months follow-up</time_frame>
      <description>Visual analog scale consisting of a straight line segment (10 cm length), the ends of which correspond to &quot;no pain&quot; (0) and &quot;the strongest pain imaginable&quot; (10).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EuroQol Visual Analogue Scale (EQ-VAS)</measure>
      <time_frame>baseline, 2 months, 6 months, 12 months follow-up</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tegner Activity Level Scale</measure>
      <time_frame>baseline, 2 months, 6 months, 12 months follow-up</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective parameters- Range of Motion</measure>
      <time_frame>baseline, 2 months, 6 months, 12 months follow-up</time_frame>
      <description>Evaluation of the Range of Motion for comparative analysis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective parameters - Circumferences</measure>
      <time_frame>baseline, 2 months, 6 months, 12 months follow-up</time_frame>
      <description>Bilateral trans- and supra- patellar circumferences measurement for comparative analysis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Acceptable Symptom State (PASS)</measure>
      <time_frame>baseline, 2 months, 6 months, 12 months follow-up</time_frame>
      <description>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 &quot;yes&quot; or &quot;no.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Minimally Clinical Important Difference (MCID)</measure>
      <time_frame>baseline, 2 months, 6 months, 12 months follow-up</time_frame>
      <description>The patient should indicate the degree of perceived improvement after the infiltrative procedure.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Expectations about the effectiveness of the treatment</measure>
      <time_frame>baseline</time_frame>
      <description>The patient should indicate at baseline what clinical benefits he or she expects from the treatment according to the question, &quot;What benefits do you expect to get as a result of the treatment you will undergo?&quot; the patient can choose from one of the following items:Full recovery, Definitely better, Much better, Slightly better,No change</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Kellgren-Lawrence score</measure>
      <time_frame>baseline, 12 months follow-up</time_frame>
      <description>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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>3 Tesla Nuclear Magnetic Resonance Imaging (3T MRI)</measure>
      <time_frame>baseline, 12 months follow-up</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Analysis of circulating micro RNAs</measure>
      <time_frame>baseline, 2 months, 6 months, 12 months follow-up</time_frame>
      <description>miRNAs, involved in OA progression, will be identified and quantified, including miR675-5p, miR-31-5p and miR-33a-5p</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">204</enrollment>
    <condition>Knee Osteoarthritis</condition>
    <arm_group>
      <arm_group_label>single intra-articular injection of BMAC</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients randomized in this group will undergo single knee intra-articular injection of bone marrow aspirate concentrate (BMAC)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>single intra-articular injection of MM-AT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients randomized in this group will undergo single knee intra-articular injection of minimally manipulated adipose tissue (MM-AT)</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Bone marrow aspirate concentrate injection</intervention_name>
      <description>single intra-articular injection of Bone Marrow aspirate concentrate derived from the patient's iliac crest</description>
      <arm_group_label>single intra-articular injection of BMAC</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>intra-articular injection of Minimally manipulated adipose tissue</intervention_name>
      <description>single intra-articular injection of Minimally manipulated adipose tissue derived from the patient's abdominal adipose tissue</description>
      <arm_group_label>single intra-articular injection of MM-AT</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients with symptomatic unilateral knee OA with:&#xD;
  &#xD;
            1. Men or women aged 40 to 75 years;&#xD;
  &#xD;
            2. Signs and symptoms of OA with a clinical history of gonalgia or swelling for at least&#xD;
               6 months;&#xD;
  &#xD;
            3. Radiographic signs of OA (Kellgren-Lawrence grade 1-4);&#xD;
  &#xD;
            4. No benefit after at least 4 months of conservative treatment;&#xD;
  &#xD;
            5. Ability and consent of patients to actively participate in clinical and radiological&#xD;
               (rx and MRI) follow-up;&#xD;
  &#xD;
            6. Signing of informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients unable to express consent;&#xD;
  &#xD;
            2. Patients aged &lt; to 40 and &gt; to 75 years;&#xD;
  &#xD;
            3. Patients with axial deviations &gt; 5°;&#xD;
  &#xD;
            4. Patients who have suffered trauma or undergone intra-articular infiltration of other&#xD;
               substance in the previous 6 months;&#xD;
  &#xD;
            5. Patients who have undergone knee surgery in the previous 12 months;&#xD;
  &#xD;
            6. Patients with concomitant knee injuries causing joint pain or swelling (-focal&#xD;
               full-thickness osteochondral defects, acute meniscal injuries);&#xD;
  &#xD;
            7. Patients with malignant neoplasms;&#xD;
  &#xD;
            8. Patients with uncompensated systemic diseases (rheumatic diseases, metabolic disorders&#xD;
               such as diabetes and thyroid diseases);&#xD;
  &#xD;
            9. Patients with infectious diseases;&#xD;
  &#xD;
           10. Patients with histories of alcohol or drug abuse;&#xD;
  &#xD;
           11. Patients who are pregnant;&#xD;
  &#xD;
           12. Patients with allergies to anesthetics used in the procedure.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Luca Andriolo, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Luca Andriolo, MD</last_name>
      <phone>6366567</phone>
      <phone_ext>051</phone_ext>
      <email>luca.andriolo@ior.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Roberta Licciardi, MSc</last_name>
      <phone>6366567</phone>
      <phone_ext>051</phone_ext>
      <email>roberta.licciardi@ior.it</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Istituto Ortopedico Rizzoli</name>
        <address>
          <city>Bologna</city>
          <zip>40136</zip>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Luca Andriolo, MD</last_name>
        <phone>6366567</phone>
        <phone_ext>051</phone_ext>
        <email>luca.andriolo@ior.it</email>
      </contact>
      <contact_backup>
        <last_name>Roberta Licciardi, MSc</last_name>
        <phone>6366567</phone>
        <phone_ext>051</phone_ext>
        <email>roberta.licciardi@ior.it</email>
      </contact_backup>
      <investigator>
        <last_name>Francesca Veronesi, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Alessandro Di Martino, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Angelo Boffa, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Stefano Zaffagnini, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Marco Franceschini, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Iacopo Romandini, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Gianluca Giavaresi, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Viviana Costa, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Deyanira Contartese, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Silvia Brogini, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Melania Maglio, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Veronica Borsari, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Marco Miceli, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Paolo Spinnato, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
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      <citation>Pagani S, Veronesi F, Giavaresi G, Filardo G, Papio T, Romandini I, Fini M. Autologous Protein Solution Effect on Chondrogenic Differentiation of Mesenchymal Stem Cells from Adipose Tissue and Bone Marrow in an Osteoarthritic Environment. Cartilage. 2021 Dec;13(2_suppl):225S-237S. doi: 10.1177/1947603521993217. Epub 2021 Feb 15.</citation>
      <PMID>33583216</PMID>
    </reference>
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      <citation>Pagani S, Borsari V, Veronesi F, Ferrari A, Cepollaro S, Torricelli P, Filardo G, Fini M. Increased Chondrogenic Potential of Mesenchymal Cells From Adipose Tissue Versus Bone Marrow-Derived Cells in Osteoarthritic In Vitro Models. J Cell Physiol. 2017 Jun;232(6):1478-1488. doi: 10.1002/jcp.25651. Epub 2016 Oct 26.</citation>
      <PMID>27739057</PMID>
    </reference>
    <reference>
      <citation>Shanmugasundaram S, Vaish A, Chavada V, Murrell WD, Vaishya R. Assessment of safety and efficacy of intra-articular injection of stromal vascular fraction for the treatment of knee osteoarthritis-a systematic review. Int Orthop. 2021 Mar;45(3):615-625. doi: 10.1007/s00264-020-04926-x. Epub 2021 Jan 12.</citation>
      <PMID>33432400</PMID>
    </reference>
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      <citation>Veronesi F, Berni M, Marchiori G, Cassiolas G, Muttini A, Barboni B, Martini L, Fini M, Lopomo NF, Marcacci M, Kon E. Evaluation of cartilage biomechanics and knee joint microenvironment after different cell-based treatments in a sheep model of early osteoarthritis. Int Orthop. 2021 Feb;45(2):427-435. doi: 10.1007/s00264-020-04701-y. Epub 2020 Jul 14.</citation>
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    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>bone marrow aspirate concentrate</keyword>
    <keyword>minimally manipulated adipose tissue</keyword>
    <keyword>BMAC</keyword>
    <keyword>MM-AT</keyword>
    <keyword>intra-articular injection</keyword>
    <keyword>knee injection</keyword>
    <keyword>mesenchymal stromal cells</keyword>
    <keyword>Randomized controlled trial</keyword>
    <keyword>cellular orthobiological products</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
      <mesh_term>Osteoarthritis, Knee</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06040957
  org study id: MAST-GR
  nct id: NCT06040957
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This is a randomized trial with 1:1 allocation.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: 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.
  measure: Western Ontario and McMaster University Osteoarthritis index (WOMAC) - Pain subscale
  time frame: 6 months follow-up
  description: It is a pathology-specific questionnaire used for the assessment of referred pain at the knee joint level in patients with OA
  measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
  time frame: baseline, 2 months, 6 months, 12 months follow-up
  description: 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
  measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
  time frame: baseline, 2 months, 6 months, 12 months follow-up
  description: 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
  measure: Visual Analogue Scale (VAS)
  time frame: baseline, 2 months, 6 months, 12 months follow-up
  description: 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).
  measure: EuroQol Visual Analogue Scale (EQ-VAS)
  time frame: baseline, 2 months, 6 months, 12 months follow-up
  description: 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).
  measure: Tegner Activity Level Scale
  time frame: baseline, 2 months, 6 months, 12 months follow-up
  description: 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.
  measure: Objective parameters- Range of Motion
  time frame: baseline, 2 months, 6 months, 12 months follow-up
  description: Evaluation of the Range of Motion for comparative analysis.
  measure: Objective parameters - Circumferences
  time frame: baseline, 2 months, 6 months, 12 months follow-up
  description: Bilateral trans- and supra- patellar circumferences measurement for comparative analysis
  measure: Patient Acceptable Symptom State (PASS)
  time frame: baseline, 2 months, 6 months, 12 months follow-up
  description: 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.
  measure: Minimally Clinical Important Difference (MCID)
  time frame: baseline, 2 months, 6 months, 12 months follow-up
  description: The patient should indicate the degree of perceived improvement after the infiltrative procedure.
  measure: Expectations about the effectiveness of the treatment
  time frame: baseline
  description: 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
  measure: Kellgren-Lawrence score
  time frame: baseline, 12 months follow-up
  description: 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
  measure: 3 Tesla Nuclear Magnetic Resonance Imaging (3T MRI)
  time frame: baseline, 12 months follow-up
  description: 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.
  measure: Analysis of circulating micro RNAs
  time frame: baseline, 2 months, 6 months, 12 months follow-up
  description: miRNAs, involved in OA progression, will be identified and quantified, including miR675-5p, miR-31-5p and miR-33a-5p
  arm group label: single intra-articular injection of BMAC
  arm group type: Experimental
  description: Patients randomized in this group will undergo single knee intra-articular injection of bone marrow aspirate concentrate (BMAC)
  arm group label: single intra-articular injection of MM-AT
  arm group type: Experimental
  description: Patients randomized in this group will undergo single knee intra-articular injection of minimally manipulated adipose tissue (MM-AT)
  intervention type: Biological
  intervention name: Bone marrow aspirate concentrate injection
  description: single intra-articular injection of Bone Marrow aspirate concentrate derived from the patient's iliac crest
  arm group label: single intra-articular injection of BMAC
  intervention type: Biological
  intervention name: intra-articular injection of Minimally manipulated adipose tissue
  description: single intra-articular injection of Minimally manipulated adipose tissue derived from the patient's abdominal adipose tissue
  arm group label: single intra-articular injection of MM-AT
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Luca Andriolo, MD
  role: Principal Investigator
  affiliation: Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica
  last name: Luca Andriolo, MD
  phone: 6366567
  phone ext: 051
  email: luca.andriolo@ior.it
  last name: Roberta Licciardi, MSc
  phone: 6366567
  phone ext: 051
  email: roberta.licciardi@ior.it
  facility: 
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  country: Italy
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  PMID: 32118081
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  PMID: 36627953
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  PMID: 32713185
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  PMID: 21726829
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  citation: Veronesi F, Maglio M, Contartese D, Martini L, Muttini A, Fini M. Stromal Vascular Fraction and Amniotic Epithelial Cells: Preclinical and Clinical Relevance in Musculoskeletal Regenerative Medicine. Stem Cells Int. 2021 Feb 18;2021:6632052. doi: 10.1155/2021/6632052. eCollection 2021.
  PMID: 33688354
  responsible party type: Sponsor
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee