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Manufacturing of Allogeneic Adipose Tissue-derived Mesenchymal Stromal Cells for Treatment of Severe Systemic Sclerosis (Pre_MSC-AT-SSc)

Primary Purpose

Mesenchymal Stromal Cell, Systemic Sclerosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Adipose tissue harvesting
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mesenchymal Stromal Cell

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age ≥ 18 and ≤ 55 years BMI <30 Non-smoker Admission for a pre-scheduled plastic surgery intervention liposuction or lipo-aspiration in the abdominal wall under general anesthesia Written consent Affiliated to a social security Exclusion Criteria: Weight < 50 kg Positive viral serology : Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Hepatitis E Virus (HEV), syphilis, Human T Lymphotropic virus (HTLV), active infection with IgM+ for toxoplasmosis, Epsiten Barr Virus (EBV), Cytomegalovirus (CMV) Active generalized infection (viral, parasitic, tuberculosis, leprosy...) Significant comorbidities according to donor health history or existing risk factors for viral infections within the past 12 months: Multiple sexual partners between the donor or his or her usual partner Intravenous addiction to the donor or regular partner Accident of exposure to blood or derivatives suspected of being contaminated Uncontrolled hypertension Human dura mater transplant Surgical history of the central nervous system Dementia or neurological disease that may evoke subacute spongiform encephalopathy Family history as part of subacute spongiform encephalopathy Hematological malignancies Active or any past history of cancer History of chemotherapy or irradiation Systemic or autoimmune disease Multiple adenopathy, splenomegaly, hepatomegaly Icterus Haemophilia Known insulin-dependent diabetes Treatment with extractive pituitary hormones (including growth hormones) Steroids therapy (for more than 5 days) in the past 3 months Lithium treatment Pregnancy Deprived of freedom

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Adults who are planned to undergo plastic surgery

    Arm Description

    Adults who are planned to undergo plastic surgery for abdominal liposuction or lipoaspiration under general anaesthetic for their own care and who are voluntary for fat donation to contribute to the study

    Outcomes

    Primary Outcome Measures

    Production of at least 3 batches of MSC(AT) derived from donors adipose tissue

    Secondary Outcome Measures

    Percentage of viability
    Percentage of CD73+ cells
    Percentage of CD90+ cells
    Percentage of CD105+ cells
    Percentage of expression of HLA-DR

    Full Information

    First Posted
    July 7, 2023
    Last Updated
    July 7, 2023
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05947682
    Brief Title
    Manufacturing of Allogeneic Adipose Tissue-derived Mesenchymal Stromal Cells for Treatment of Severe Systemic Sclerosis
    Acronym
    Pre_MSC-AT-SSc
    Official Title
    Manufacturing of Allogeneic Adipose Tissue-derived Mesenchymal Stromal Cells for Treatment of Severe Systemic Sclerosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    February 2025 (Anticipated)
    Study Completion Date
    February 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

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

    5. Study Description

    Brief Summary
    Mesenchymal stromal cells (MSC) are multipotent cells which carry immunomodulatory, pro-angiogenic and anti-fibrotic properties, that can target Systemic Sclerosis (SSc) pathogenesis and its clinical manifestations. The increasing use of MSC, harvested from bone marrow (MSC(M)), adipose tissue (MSC(AT)), or umbilical cord (MSC(UC)) in a variety of indications, provides consistent evidence supporting their safety in humans. The efficacy of MSC(M) intravenous (IV) injection for treating acute graft versus host disease led to their marketing approval in 2012 and MSC(AT) (Alofisel) were approved for severe Crohn's fistula in 2018. MSC represent a promising therapeutic approach for SSc. We previously a) showed disease-specific abnormalities in MSC(M) from SSc patients, providing strong rationale to use allogeneic MSC to treat SSc patients, b) completed the first phase I/II dose escalation trial using allogenic MSC(M) infusion in 20 severe SSc patients (ClinicalTrials.gov: NCT02213705, PHRC AOM 11-250) with no safety issues, significant improvement in skin fibrosis at 3 to 6 months after infusion which appeared lower thereafter, thereby supporting the need for repeated infusions. In vitro, experimental and clinical studies suggest that MSC properties vary according to their tissue of origin/source. We demonstrated that compared to MSC(M), MSC(AT) are easier to harvest and display higher proliferative capability before entering senescence, higher genetic stability, and superior immunosuppressive properties. The objective of the present research is the successful production of allogeneic MSC(AT) derived from selected healthy donors, with adequate phenotypic criteria according to the International Society for Cell & Gene Therapy. Considering the above rationale, these MSC(AT) will subsequently be used in a Phase I/II randomized clinical trial testing allogeneic MSC(AT) systemic infusion for treatment of severe systemic sclerosis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mesenchymal Stromal Cell, Systemic Sclerosis

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    6 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Adults who are planned to undergo plastic surgery
    Arm Type
    Other
    Arm Description
    Adults who are planned to undergo plastic surgery for abdominal liposuction or lipoaspiration under general anaesthetic for their own care and who are voluntary for fat donation to contribute to the study
    Intervention Type
    Other
    Intervention Name(s)
    Adipose tissue harvesting
    Intervention Description
    Adipose tissue harvesting (40-60g) during the abdominal liposuction or lipoaspiration under general anaesthesia which is performed according to usual care
    Primary Outcome Measure Information:
    Title
    Production of at least 3 batches of MSC(AT) derived from donors adipose tissue
    Time Frame
    Up to 2 months
    Secondary Outcome Measure Information:
    Title
    Percentage of viability
    Time Frame
    Up to 2 months
    Title
    Percentage of CD73+ cells
    Time Frame
    Up to 2 months
    Title
    Percentage of CD90+ cells
    Time Frame
    Up to 2 months
    Title
    Percentage of CD105+ cells
    Time Frame
    Up to 2 months
    Title
    Percentage of expression of HLA-DR
    Time Frame
    Up to 2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 and ≤ 55 years BMI <30 Non-smoker Admission for a pre-scheduled plastic surgery intervention liposuction or lipo-aspiration in the abdominal wall under general anesthesia Written consent Affiliated to a social security Exclusion Criteria: Weight < 50 kg Positive viral serology : Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Hepatitis E Virus (HEV), syphilis, Human T Lymphotropic virus (HTLV), active infection with IgM+ for toxoplasmosis, Epsiten Barr Virus (EBV), Cytomegalovirus (CMV) Active generalized infection (viral, parasitic, tuberculosis, leprosy...) Significant comorbidities according to donor health history or existing risk factors for viral infections within the past 12 months: Multiple sexual partners between the donor or his or her usual partner Intravenous addiction to the donor or regular partner Accident of exposure to blood or derivatives suspected of being contaminated Uncontrolled hypertension Human dura mater transplant Surgical history of the central nervous system Dementia or neurological disease that may evoke subacute spongiform encephalopathy Family history as part of subacute spongiform encephalopathy Hematological malignancies Active or any past history of cancer History of chemotherapy or irradiation Systemic or autoimmune disease Multiple adenopathy, splenomegaly, hepatomegaly Icterus Haemophilia Known insulin-dependent diabetes Treatment with extractive pituitary hormones (including growth hormones) Steroids therapy (for more than 5 days) in the past 3 months Lithium treatment Pregnancy Deprived of freedom
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dominique Farge, Pr
    Phone
    +33142499768
    Email
    dominique.farge-bancel@aphp.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jérôme Lambert, Dr
    Phone
    +33142499742
    Email
    jerome.lambert@u-paris.fr

    12. IPD Sharing Statement

    Learn more about this trial

    Manufacturing of Allogeneic Adipose Tissue-derived Mesenchymal Stromal Cells for Treatment of Severe Systemic Sclerosis

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