NCT03211793View on ClinicalTrials.gov

Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic Sclerosis

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 6, 2021

Primary Completion Date

November 1, 2026

Study Completion Date

November 1, 2026

Conditions
Systemic SclerosisDigital Ulcer
Interventions
DRUG

Mesenchymal stromal cells

8 intramuscular injections at designated sites in the hand/forearm muscles of the most affected side. Blinded syringes will be used. Injections will be administered by an experienced clinician (plastic surgeon or hand surgeon).

OTHER

Placebo

8 intramuscular injections at designated sites in the hand/forearm muscles of the most affected side. Blinded syringes will be used. Injections will be administered by an experienced clinician (plastic surgeon or hand surgeon).

Trial Locations (1)

3584 CX

RECRUITING

Universitair Medisch Centrum Utrecht, Utrecht

All Listed Sponsors
collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

lead

UMC Utrecht

OTHER