Subcutaneous Injections of Cultured Adipose-derived Stroma/ Stem Cells to Heal Refractory Ischemic Digital Ulcers in Patients With Scleroderma

Who is this study for? Adult patients with systemic sclerosis
What treatments are being studied? Adipose tissue harvest+Autologous ASC
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female patient ≥18 years of age,

• Patient with systemic sclerosis according to the 2013 ACR/EULAR classification criteria9,

• SSc patient with at least one refractory active ischemic digital ulcer at inclusion visit (see below the eligibility conditions of a DU),

• Age \> 50 years and not treated with any kind of hormone replacement therapy for at least 2 years prior to screening, with amenorrhea for at least 24 consecutive months prior to screening. An assessment of serum follicle stimulating hormone showing a level of \> 40 TU/L at screening may be used to exclude childbearing potential, based on the discretion of the investigator,

• Patient must have provided written informed consent prior to enrolment,

• Patient must be able to understand their requirements of participating in the protocol,

• Patient affiliated to a social security system.

• Relative to each DU :

‣ The DU at inclusion visit must show all the following characteristics:

⁃ Located beyond the proximal interphalangeal joint, on finger surface (included periungual ulcers),

⁃ Of ischemic origin according to the physician,

⁃ Not over subcutaneous calcifications or bone relief,

⁃ Active DU,

⁃ Refractory after 10±2 weeks of standard of care according to EULAR recommendations26 (that is either still active (chronic) or new occurrence despite standard of care)

Locations
Other Locations
France
Grenoble Hospital
NOT_YET_RECRUITING
Grenoble
Lille Hopsital
NOT_YET_RECRUITING
Lille
Marseille Hospital
NOT_YET_RECRUITING
Marseille
Montpellier Hospital
NOT_YET_RECRUITING
Montpellier
Nantes Hospital
NOT_YET_RECRUITING
Nantes
Poitiers Hospital
NOT_YET_RECRUITING
Poitiers
CHU de Toulouse - Hôpital PURPAN-TSA
RECRUITING
Toulouse
Contact Information
Primary
Grégory PUGNET, MD, PHD
pugnet.g@chu-toulouse.fr
05 61 77 71 26
Time Frame
Start Date: 2020-09-22
Estimated Completion Date: 2025-12
Participants
Target number of participants: 32
Treatments
Experimental: AdMSC
Subcutaneous injections of cultured adipose-derived stroma/stem cells to heal refractory ischemic digital ulcers in patients with scleroderma
Placebo_comparator: Placebo
Subcutaneous injections of placebo comparator to heal refractory ischemic digital ulcers in patients with scleroderma
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Toulouse

This content was sourced from clinicaltrials.gov