Adipose tissu derived-stem cells injections from patients with sclerodermia to treat thier refractory digital ulcers.

Phase 1

• Conditions: Patients with systemic sclerosis presenting digital ulcer :- located beyond the proximal interphalangeal joint, on finger surface (included periungueal 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 (that is either still active or new occurrence despite standard of care); Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2019-003906-28-FR
• Lead Sponsor: CHU de Toulouse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-18
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

-Over 18 years old systemic sclerosis according to the 2013 ACR/EULAR classification criteria,
-at least one digital ulcer at baseline showing all the following characteristics:
a) located beyond the proximal interphalangeal joint, on finger surface (included periungueal ulcers),
b) of ischemic origin according to the physician,
c) not over subcutaneous calcifications or bone relief,
d) active DU,
e) refractory after 10±2 weeks of standard of care (that is either still active or new occurrence despite standard of care)
- Women of childbearing potential must use a reliable method of contraception. Women of childbearing potential with a negative serum pre-treatment pregnancy test are allowed in the study if they consistently and correctly use (from screening and up to 30 days after study treatment discontinuation) a reliable method of contraception
- 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Relative to the patient
-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,
- 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),
- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified