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 autologous cultured adipose-derived stromal 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 autologous cultured adipose-derived stromal cell versus placebo for healing refractory active ischemic digital ulcers in patients with systemic sclerosis.
Systemic sclerosis (SSc) is a systemic autoimmune disease characterized by an autoimmune-mediated microangiopathy and progressive fibrosis. Ischemic digital ulcers (DUs) are frequent in the disease course. DUs are an expression of the severity of the microangiopathy. DUs lead to pain, infection, gangrene, autoamputation, impaired hand use and impaired quality of life. The management of DUs is often based on optimal wound care to promote healing and and repeated hospitalizations to perform onerous prostacyclin infusions to reduce pain and accelerate healing. With optimal standard of care, only 60% of DUs are healed after 3 months and 46.2% experiences recurrence during that time among them 11.2% experiences a chronic evolution. No drug has demonstrated a positive effect on refractory DUs healing. The rational underlying the use of cultured adipose-derived stromal cell (ASC) in this indication is based on the finding of ASC, in vitro and in vivo, angiogenic and anti-inflammatory potential in other ischemic pathologies, with an excellent safety profile. The pilot phase of the ACellDREAM trial demonstrated the feasibility and safety of autologous ASC transplantation in patients with non- revascularizable critical limb ischemia and showed improvement in ulcer evolution and wound healing. The EFS-O culture procedure safety is validated and is already in use in ongoing French and European clinical trials. Two pilot studies showed the safety of autologous adipose tissue grafting for scleroderma-Induced DU. The SCLERADEC pilot study outlines the safety, in 12 SSc patients, of the digital injection of adipose- derived autologous stromal vascular fraction, which is a heterogeneous population of cells including only 36% of uncultured ASC. An improvement in hand disability, quality of life and DUs was observed, the phase II is ongoing. The hypothesis of the study is that digital injection of autologous cultured adipose-derived stromal cell could be efficacious for scleroderma-induced refractory ischemic DUs healing by digital vascular regeneration in a clinical situation where no alternative therapy is validated.
| Condition | CONNECTIVE TISSUE DISEASE, Connective Tissue Diseases, Dermatomyositis (Connective Tissue Disease), Scleroderma, Systemic sclerosis, Scleroderma, Dermatosis, Congenital Skin Diseases, Skin Conditions, Dermatomyositis (Connective Tissue Disease), Congenital Skin Diseases, Skin Conditions, Connective Tissue Diseases, progressive systemic sclerosis |
|---|---|
| Treatment | Placebo, Adipose tissue harvest, Autologous ASC |
| Clinical Study Identifier | NCT04356755 |
| Sponsor | University Hospital, Toulouse |
| Last Modified on | 1 June 2023 |
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