Actively Recruiting
Subcutaneous Injections of ASC to Heal Digital Ulcers in Patients With Scleroderma.
Led by University Hospital, Toulouse · Updated on 2025-12-31
32
Participants Needed
7
Research Sites
335 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Subcutaneous Injections of ASC to Heal Digital Ulcers in Patients With Scleroderma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patient 18 years of age or older
- Diagnosis of systemic sclerosis according to the 2013 ACR/EULAR classification criteria
- Presence of at least one refractory active ischemic digital ulcer at the time of inclusion
- For patients over 50 years, no hormone replacement therapy for at least 2 years and amenorrhea for at least 24 months prior to screening; serum follicle stimulating hormone > 40 TU/L may be used to confirm exclusion of childbearing potential
- Ability to provide written informed consent
- Ability to understand study requirements
- Affiliated with a social security system
- Each digital ulcer must be located beyond the proximal interphalangeal joint on the finger surface, be of ischemic origin, not over subcutaneous calcifications or bone, active, and refractory after 10±2 weeks of standard care
You will not qualify if you...
- Current smoker or tobacco use stopped less than 3 months before inclusion
- Participation in a clinical trial within the previous 3 months
- Use of statins for less than 3 months or unstable treatment
- Use of vasodilators or related medications for less than 3 months or unstable treatment
- Treatment with disease modifying agents within 1 month prior to study
- Oral corticosteroids over 10 mg/day prednisone or equivalent
- Systemic antibiotics for infected digital ulcers within 4 weeks prior to inclusion
- Use of topical growth factors or hyperbaric oxygen
- Local botulinum toxin injection in affected finger within 4 weeks prior to inclusion
- Surgical sympathectomy or wound debridement in upper limbs within 1 month prior to inclusion
- Liposuction technically impossible
- Autologous hematopoietic stem cell transplant within 1 year
- Indication for intensification by autologous HSCT
- History of cancer in last 5 years except certain successfully treated skin cancers
- Active proliferative retinopathy
- Positive for HIV-1/2, HTLV-1/2, HBV, or HCV
- History of stroke, myocardial infarction, or severe arrhythmia in last 6 months
- Severe cardiac failure in last 6 months
- Pregnant or breastfeeding females or planning pregnancy during study
- Under judicial protection or refusal to participate
- Digital ulcers due to non-scleroderma causes, non-ischemic ulcers, ulcers with osteomyelitis or uncontrolled infection, infected ulcers requiring systemic antibiotics, or ulcers requiring urgent surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Grenoble Hospital
Grenoble, France
Not Yet Recruiting
2
Lille Hopsital
Lille, France
Not Yet Recruiting
3
Marseille Hospital
Marseille, France
Not Yet Recruiting
4
Montpellier Hospital
Montpellier, France
Not Yet Recruiting
5
Nantes Hospital
Nantes, France
Not Yet Recruiting
6
Poitiers Hospital
Poitiers, France
Not Yet Recruiting
7
CHU de Toulouse - Hôpital PURPAN-TSA
Toulouse, France, 31059
Actively Recruiting
Research Team
G
Grégory PUGNET, MD, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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