SUBCUTANEOUS INJECTIONS OF CULTURED ADIPOSE-DERIVED STROMA/ STEM CELLS TO HEAL REFRACTORY ISCHEMIC DIGITAL ULCERS IN PATIENTS WITH SCLERODERMA: A PHASE II STUDY

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508432-53-00

Acronym

RC31/17/0447

Enrollment

Registered

2023-10-27

Start date

2020-09-22

Completion date

Unknown

Last updated

2026-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic sclerosis

Brief summary

Proportion of refractory active ischemic digital ulcers healed (complete or partial) without recurrence at 16 weeks. The main evaluation criterion is a composite endpoint combining healing (complete or partial) without recurrence at 16 weeks and without local or general complications.

Interventions

DRUG5 ml containing 5% human albumin and Cryostor®CS10

DRUGCellReady

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Proportion of refractory active ischemic digital ulcers healed (complete or partial) without recurrence at 16 weeks. The main evaluation criterion is a composite endpoint combining healing (complete or partial) without recurrence at 16 weeks and without local or general complications.	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026