Subcutaneous Injections of ASC to Heal Digital Ulcers in Patients With Scleroderma.

Korábbi kezelés

• 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,
• 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",
• 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",
• Patient who underwent autologous hematopoietic stem cell transplantation (HSCT) within less than 1 year,

Más betegség

• 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,
• 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.

Laborértékek

• 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",

Egyéb

• Use of topical growth factors, hyperbaric oxygen,
• Liposuction technically impossible,
• Patients with an indication for intensification by autologous HSCT (according to EBMT guidelines and national RCP MATHEC),
• 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.

• 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)