An interventional study of Adipose tissue harvesting in Mesenchymal Stromal Cell and Systemic Sclerosis, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-17.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other
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.
688 studies on the registry are indexed under Scleroderma, Systemic; 223 are open to participants now.
This study's planned enrollment of 6 is below the median of 34 across 493 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion Criteria:
Significant comorbidities according to donor health history or existing risk factors for viral infections within the past 12 months:
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
Other: Adipose tissue harvesting
Adipose tissue harvesting (40-60g) during the abdominal liposuction or lipoaspiration under general anaesthesia which is performed according to usual care
Production of at least 3 batches of MSC(AT) derived from donors adipose tissue
Time frame: Up to 2 months
Percentage of viability
Time frame: Up to 2 months
Percentage of CD73+ cells
Time frame: Up to 2 months
Percentage of CD90+ cells
Time frame: Up to 2 months
Percentage of CD105+ cells
Time frame: Up to 2 months
Percentage of expression of HLA-DR
Time frame: Up to 2 months
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris