Status:
RECRUITING
Subcutaneous Injections of ASC to Heal Digital Ulcers in Patients With Scleroderma.
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Systemic Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 (Ad...
Detailed Description
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 co...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- Current smoker or tobacco consumption stopped for less than 3 months prior to inclusion, - Patient participating in a clinical trial or having participated in a clinical trial within the previous 3 months,
- Patients on statins, who have received treatment for less than 3 months prior to Screening or whose treatment has not been stable during this period,
- Patients on vasodilators, such as endothelin receptor antagonists (ERAs), PDE5 inhibitors (e.g. sildenafil, tadalafil), calcium channel blockers, ACE-inhibitors, nitroglycerin, alpha adrenergic blockers, or angiotensin II receptor antagonists, N-acetylcysteine, antiplatelet aggregation therapy and low molecular weight heparin who have received treatment if present for less than 3 months prior to "inclusion visit" or whose treatment has not been stable for at least 1 month prior to "inclusion visit",
- Treatment with disease modifying agents such as methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, Interferons and cyclophosphamide, those drugs should be stop at least 1 month prior study entry.
- Treatment with oral corticosteroids (\> 10 mg/day of prednisone or equivalent),
- Systemic antibiotics (oral and TV) to treat infected DU(s) within 4 weeks prior to "inclusion visit",
- Use of topical growth factors, hyperbaric oxygen,
- Local injection of botulinum toxin in an affected finger within 4 weeks prior to "inclusion visit",
- Surgical sympathectomy of the upper limbs or surgical wound debridement within 1 month prior to "inclusion visit",
- Liposuction technically impossible,
- Patient who underwent autologous hematopoietic stem cell transplantation (HSCT) within less than 1 year,
- Patients with an indication for intensification by autologous HSCT (according to EBMT guidelines and national RCP MATHEC),
- History of cancer in the last five years, except for successfully excised basal cell/squamous cell carcinoma, or successfully excised early melanoma of the skin. Subjects, who had successfully tumor resection or radiation or chemotherapy more than 5 years from inclusion and no recurrence, may be enrolled in the study, - Subjects who have active proliferative retinopathy,
- Positive HIV-1 or 2, HTLV-1 or 2, HBV or HCV,
- Patients with a history of stroke, myocardial infarction or severe arrhythmia in the last 6 months
- Patient who had severe cardiac failure in the last 6 months,
- Females who are pregnant or breastfeeding or plan to do so during the course of this study,
- Patient under judicial protection, - Refusal of the patient to participate in the study.
- Relative to each DU:
- Digital ulcer due to conditions other than scleroderma,
- Non ischemic digital ulcer,
- Ulcers with osteomyelitis, or clinically uncontrolled infection,
- Infected digital ulcer requiring systemic antibiotherapy,
- Digital ulcer requiring urgent surgery.
Key Trial Info
Start Date :
September 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04356755
Start Date
September 22 2020
End Date
March 1 2027
Last Update
December 31 2025
Active Locations (7)
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1
Grenoble Hospital
Grenoble, France
2
Lille Hopsital
Lille, France
3
Marseille Hospital
Marseille, France
4
Montpellier Hospital
Montpellier, France