Subcutaneous Injections of ASC to Heal Digital Ulcers in Patients With Scleroderma.

Summary

Ischemic digital ulcers (DUs) are a frequent complication in systemic sclerosis with a major impact on hand function and quality of life. Digital injection of cultured adipose-derived stromal cell (AdMSC) constitutes a promising approach to treat scleroderma-induced refractory ischemic DUs where no alternative therapy is validated. The aim of this phase 2 study is to compare efficacy and safety of digital injection of AdMSC versus placebo for healing refractory active ischemic digital ulcers in patients with systemic sclerosis.

Timeline

Start

2020-09-22

Primary completion

2027-03

Completion

2027-03

Drugs

Indications