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Randomized Control Trial Comparison Between Intra-articular Infiltrations of PRP, MFAT, and PRP-MFAT in the Treatment of Symptomatic Knee Osteoarthritis. (MICROPREP3)

Primary Purpose

Osteo Arthritis Knee

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Intra-articular injection of autologous microfat
Intra-articular injection of autologous platelet-rich plasma
Intra-articular injection of autologous microfat and platelet-rich plasma
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients of both gender, between 20 and 75 year-old. Symptomatics degenerativ or post traumatic chondropathy, on at least one of the 3 knee compartments ICRS grade 2, 3 or 4 with VAS>4 and failure of well-conducted medical treatment for at least 1 year (palliative analgesics adapted to the pain, AINS, rehabilitation by a physiotherapist, injections intra-articulaires de corticoïdes et/ou d'acide hyaluronique) Varus or valgus less than or equal to 5°. BMI greater than 20 (in order to have sufficient fatty tissue) Informed consent signed by the patient HB > 10g/dl Negative beta-HCG at inclusion and effective contraception for patients of childbearing age, for 1 month. Beneficiaries of or affiliated to a social security system Exclusion Criteria: Contraindications to MRI : ocular foreign bodies, pacemaker, neurostimulator, cochlear implant, vascular clips, metallic heart valve Body mass index (BMI) of less than 20 kg/m2 not allowig to obtain a sufficient quantity of adipose tissue. Thrombocytopenia < 150 G/L Thrombocytosis > 450 G/L Known thrombopathy TP=> PR < 70%. TCA=> APR > 1.20s Anemia HB < 10g/dl Positive markers for the following active infectious diseases: HIV 1 and HIV 2 human immunodeficiency virus infection; HTLV I and II virus infection; Hepatitis B virus infection; Hepatitis C virus infection; Syphilis causative agent infection. Use of antiplatelet agents, aspirin, anti-vitamin K drugs for less than 15 days. Chronic treatment with oral corticosteroids or the use of such treatment less than 2 weeks prior to inclusion Intra-articular corticosteroid injection less than 2 months prior to inclusion Intra-articular injection of hyaluronic acid less than 2 months prior to inclusion Non-steroidal anti-inflammatory drugs less than 15 days prior to inclusion Recent fever or infection (bacterial or viral) less than one month old Autoimmune diseases Inflammatory arthritis Immune deficiency Ongoing or chronic infectious diseases (viral or bacterial) T Malignant tumours or history of malignant tumours less than 5 years prior to inclusion Pregnant or lactating women Adults protected by law (guardianship or curatorship) Patient participating simultaneously in another research project involving the human person Minors Persons residing in a health or social institution Persons in emergency situations Persons deprived of liberty Persons not covered by the French social security scheme Contraindication to local anesthesia and/or surgery Allergy to local anesthetics Inmates

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    autologous microfat (MG)

    Platelet-rich plasma (PRP)

    Microfat autologous-Platelet-rich plasma (MG-PRP)

    Arm Description

    Patient will be hospitalized in outpatient surgery. A blood sample will be collected and a lipoaspiration will be performed under local anesthesia during the same operation by the nurses and the surgeon. Then, biological products will be immediately prepared, and a preparation of autologous MG will be injected intra-articularly by th same surgeon.

    Patient will be hospitalized in outpatient surgery. A blood sample will be collected and a lipoaspiration will be performed under local anesthesia during the same operation by the nurses and the surgeon. Then, biological products will be immediately prepared, and a preparation of autologous PRP will be injected intra-articularly by th same surgeon.

    Patient will be hospitalized in outpatient surgery. A blood sample will be collected and a lipoaspiration will be performed for the preparation during the same operation by the nurses and the surgeon. Then, biological products will be immediately prepared, and autologous microfat associated with a preparation of autologous PRP will be injected intra-articularly by th same surgeon.

    Outcomes

    Primary Outcome Measures

    KOOS score at 6 months
    KOOS assesses the short- and long-term consequences of knee injuries, as well as the consequences of primary osteoarthritis. It is percentage from 0 to 100. 0 represents extreme problems and 100 represents no problem.

    Secondary Outcome Measures

    Pain at 1 month
    Pain will assassed by a visual anatomy scale from 0 (no pain) to 10 (pain as bad as it could possibly be)
    Pain at 3 months
    Pain will assassed by a visual anatomy scale from 0 (no pain) to 10 (pain as bad as it could possibly be)
    Pain at 12 months
    Pain will assassed by a visual anatomy scale from 0 (no pain) to 10 (pain as bad as it could possibly be)
    KOOS score at 1 month
    KOOS assesses the short- and long-term consequences of knee injuries, as well as the consequences of primary osteoarthritis. It is percentage from 0 to 100. 0 represents extreme problems and 100 represents no problem.
    KOOS score at 3 months
    KOOS assesses the short- and long-term consequences of knee injuries, as well as the consequences of primary osteoarthritis. It is percentage from 0 to 100. 0 represents extreme problems and 100 represents no problem.
    KOOS score at 12 months
    KOOS assesses the short- and long-term consequences of knee injuries, as well as the consequences of primary osteoarthritis. It is percentage from 0 to 100. 0 represents extreme problems and 100 represents no problem.
    Proportion of treatment failures
    Patients are defined as treatment failures if, during the follow-up period, they undergo one of the following procedures on the treated knee, in the absence of intercurrent events: new injection (whatever the product injected), arthroscopy, arthroplasty, etc.
    Proportion of arthroplasties not performed in arthroplasty candidates

    Full Information

    First Posted
    October 10, 2023
    Last Updated
    October 10, 2023
    Sponsor
    Assistance Publique Hopitaux De Marseille
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06084637
    Brief Title
    Randomized Control Trial Comparison Between Intra-articular Infiltrations of PRP, MFAT, and PRP-MFAT in the Treatment of Symptomatic Knee Osteoarthritis.
    Acronym
    MICROPREP3
    Official Title
    Randomized Control Trial Comparison Between Intra-articular Infiltrations of PRP, MFAT, and PRP-MFAT in the Treatment of Symptomatic Knee Osteoarthritis.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2, 2024 (Anticipated)
    Primary Completion Date
    February 1, 2027 (Anticipated)
    Study Completion Date
    March 1, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique Hopitaux De Marseille

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This research protocol evaluate the efficacity of intra-articular injections of autologous microfat associated with a preparation of autologous PRP, in symptomatic, resistant to first-line medical treatment, degenerative or post-traumatic cartilage lesions of the knee. The primary objective of this study is to show the superiority of intra-articular injection of autologous microfat combined with autologous PRP preparation compared to injection of microfat or PRP used alone, on the KOOS score at 6 months.
    Detailed Description
    Osteoarthritis is the most widespread joint disease in the world, and one of the most frequent causes of pain and functional disability in Western countries. The incidence of cartilage lesions is constantly on the rise, due to the ageing of the population and the traumas associated with the development of sporting activities. Recently, the emergence of biotherapies in orthopaedics has led to the development of intra-articular injections of autologous platelet-rich plasma (PRP). Their use has been widespread since 2010, based on the demonstration that platelet-enriched plasma, a concentrate of growth factors, can stimulate cartilage regeneration in vitro and in vivo in preclinical models (Saito, Schmidt, Qi, Tchetina). In addition, PRP administration methods can be optimized: since it is a liquid preparation (platelet suspension), administering it within an interface tissue limits its diffusion and potentiates its trophic effect on the injured cartilage site. Adipose tissue represents the most relevant tissue of interest, as it is a stem cell-rich support tissue with full therapeutic potential, and is easily accessible. Thus, a sample of autologous "microfat" (adipose tissue containing small fat lobules and stem cells, harvested under local anaesthetic by manual liposuction using specific fine sampling cannulas) co-administered at the level of the synovial capsule, could play the role of fluid trophic matrix to the PRP. The hypothesis of this project is that the standardized injection of an innovative treatment (microgrease and autologous PRP dose) can defer the need for knee arthroplasty in patients with gonarthrosis resistant to first-line medical treatment. We propose to carry out a clinical study in patients with chondral knee lesions resistant to first-line medical treatment, evaluating the benefit during follow-up of treatment with intra-articular injections of microfat and a standardized preparation of autologous PRP or the combination of the 2.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteo Arthritis Knee

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    180 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    autologous microfat (MG)
    Arm Type
    Experimental
    Arm Description
    Patient will be hospitalized in outpatient surgery. A blood sample will be collected and a lipoaspiration will be performed under local anesthesia during the same operation by the nurses and the surgeon. Then, biological products will be immediately prepared, and a preparation of autologous MG will be injected intra-articularly by th same surgeon.
    Arm Title
    Platelet-rich plasma (PRP)
    Arm Type
    Experimental
    Arm Description
    Patient will be hospitalized in outpatient surgery. A blood sample will be collected and a lipoaspiration will be performed under local anesthesia during the same operation by the nurses and the surgeon. Then, biological products will be immediately prepared, and a preparation of autologous PRP will be injected intra-articularly by th same surgeon.
    Arm Title
    Microfat autologous-Platelet-rich plasma (MG-PRP)
    Arm Type
    Experimental
    Arm Description
    Patient will be hospitalized in outpatient surgery. A blood sample will be collected and a lipoaspiration will be performed for the preparation during the same operation by the nurses and the surgeon. Then, biological products will be immediately prepared, and autologous microfat associated with a preparation of autologous PRP will be injected intra-articularly by th same surgeon.
    Intervention Type
    Biological
    Intervention Name(s)
    Intra-articular injection of autologous microfat
    Intervention Description
    A preparation of autologous microfat (5mL) will be injected intra-articularly.
    Intervention Type
    Biological
    Intervention Name(s)
    Intra-articular injection of autologous platelet-rich plasma
    Intervention Description
    A preparation of autologous platelet-rich plasma (5mL) will be injected intra-articularly.
    Intervention Type
    Biological
    Intervention Name(s)
    Intra-articular injection of autologous microfat and platelet-rich plasma
    Intervention Description
    A preparation of autologous platelet-rich plasma (5mL) and autologous microfat (5mL) will be injected intra-articularly.
    Primary Outcome Measure Information:
    Title
    KOOS score at 6 months
    Description
    KOOS assesses the short- and long-term consequences of knee injuries, as well as the consequences of primary osteoarthritis. It is percentage from 0 to 100. 0 represents extreme problems and 100 represents no problem.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Pain at 1 month
    Description
    Pain will assassed by a visual anatomy scale from 0 (no pain) to 10 (pain as bad as it could possibly be)
    Time Frame
    1 month
    Title
    Pain at 3 months
    Description
    Pain will assassed by a visual anatomy scale from 0 (no pain) to 10 (pain as bad as it could possibly be)
    Time Frame
    3 months
    Title
    Pain at 12 months
    Description
    Pain will assassed by a visual anatomy scale from 0 (no pain) to 10 (pain as bad as it could possibly be)
    Time Frame
    12 months
    Title
    KOOS score at 1 month
    Description
    KOOS assesses the short- and long-term consequences of knee injuries, as well as the consequences of primary osteoarthritis. It is percentage from 0 to 100. 0 represents extreme problems and 100 represents no problem.
    Time Frame
    1 month
    Title
    KOOS score at 3 months
    Description
    KOOS assesses the short- and long-term consequences of knee injuries, as well as the consequences of primary osteoarthritis. It is percentage from 0 to 100. 0 represents extreme problems and 100 represents no problem.
    Time Frame
    3 months
    Title
    KOOS score at 12 months
    Description
    KOOS assesses the short- and long-term consequences of knee injuries, as well as the consequences of primary osteoarthritis. It is percentage from 0 to 100. 0 represents extreme problems and 100 represents no problem.
    Time Frame
    12 months
    Title
    Proportion of treatment failures
    Description
    Patients are defined as treatment failures if, during the follow-up period, they undergo one of the following procedures on the treated knee, in the absence of intercurrent events: new injection (whatever the product injected), arthroscopy, arthroplasty, etc.
    Time Frame
    12 months
    Title
    Proportion of arthroplasties not performed in arthroplasty candidates
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients of both gender, between 20 and 75 year-old. Symptomatics degenerativ or post traumatic chondropathy, on at least one of the 3 knee compartments ICRS grade 2, 3 or 4 with VAS>4 and failure of well-conducted medical treatment for at least 1 year (palliative analgesics adapted to the pain, AINS, rehabilitation by a physiotherapist, injections intra-articulaires de corticoïdes et/ou d'acide hyaluronique) Varus or valgus less than or equal to 5°. BMI greater than 20 (in order to have sufficient fatty tissue) Informed consent signed by the patient HB > 10g/dl Negative beta-HCG at inclusion and effective contraception for patients of childbearing age, for 1 month. Beneficiaries of or affiliated to a social security system Exclusion Criteria: Contraindications to MRI : ocular foreign bodies, pacemaker, neurostimulator, cochlear implant, vascular clips, metallic heart valve Body mass index (BMI) of less than 20 kg/m2 not allowig to obtain a sufficient quantity of adipose tissue. Thrombocytopenia < 150 G/L Thrombocytosis > 450 G/L Known thrombopathy TP=> PR < 70%. TCA=> APR > 1.20s Anemia HB < 10g/dl Positive markers for the following active infectious diseases: HIV 1 and HIV 2 human immunodeficiency virus infection; HTLV I and II virus infection; Hepatitis B virus infection; Hepatitis C virus infection; Syphilis causative agent infection. Use of antiplatelet agents, aspirin, anti-vitamin K drugs for less than 15 days. Chronic treatment with oral corticosteroids or the use of such treatment less than 2 weeks prior to inclusion Intra-articular corticosteroid injection less than 2 months prior to inclusion Intra-articular injection of hyaluronic acid less than 2 months prior to inclusion Non-steroidal anti-inflammatory drugs less than 15 days prior to inclusion Recent fever or infection (bacterial or viral) less than one month old Autoimmune diseases Inflammatory arthritis Immune deficiency Ongoing or chronic infectious diseases (viral or bacterial) T Malignant tumours or history of malignant tumours less than 5 years prior to inclusion Pregnant or lactating women Adults protected by law (guardianship or curatorship) Patient participating simultaneously in another research project involving the human person Minors Persons residing in a health or social institution Persons in emergency situations Persons deprived of liberty Persons not covered by the French social security scheme Contraindication to local anesthesia and/or surgery Allergy to local anesthetics Inmates
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alexandre ROCHWERGER, Pr
    Phone
    04 91 96 63 00
    Email
    richardalexandre.rochwerger@ap-hm.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alexandra GIULIANI
    Phone
    0491382870
    Email
    alexandra.giuliani@ap-hm.fr

    12. IPD Sharing Statement

    Learn more about this trial

    Randomized Control Trial Comparison Between Intra-articular Infiltrations of PRP, MFAT, and PRP-MFAT in the Treatment of Symptomatic Knee Osteoarthritis.

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