NCT06722105View on ClinicalTrials.gov

Phase I/II Randomized Clinical Trial of Allogeneic Adipose Tissue-derived Mesenchymal Stromal Cells Systemic Infusion in Severe Systemic Sclerosis

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

December 1, 2024

Primary Completion Date

April 1, 2026

Study Completion Date

May 1, 2027

Conditions
Severe Systemic Sclerosis
Interventions
BIOLOGICAL

2 infusions of MSC

1 MSC(AT) (2x10\^6 cells/kg) injection at M0 and 1 MSC(AT) (2x10\^6 cells/kg) injection at M3

BIOLOGICAL

1 infusion of MSC

1 MSC(AT) (2x10\^6 cells/kg) injection at M0 and 1 placebo injection at M3

OTHER

Placebo

Placebo at M0 and M3

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT06722105 - Phase I/II Randomized Clinical Trial of Allogeneic Adipose Tissue-derived Mesenchymal Stromal Cells Systemic Infusion in Severe Systemic Sclerosis | Biotech Hunter | Biotech Hunter