2023-508432-53-00招募中2 期
SUBCUTANEOUS INJECTIONS OF CULTURED ADIPOSE-DERIVED STROMA/ STEM CELLS TO HEAL REFRACTORY ISCHEMIC DIGITAL ULCERS IN PATIENTS WITH SCLERODERMA: A PHASE II STUDY
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 7
- 主要终点
- Proportion of refractory active ischemic digital ulcers healed (complete or partial) without recurrence at 16 weeks. The main evaluation criterion is a composite endpoint combining healing (complete or partial) without recurrence at 16 weeks and without local or general complications.
研究概览
简要总结
To compare efficacy and safety of digital injection of allogeneic adipose-derived stromal cell (CellReady®) versus placebo for healing refractory (chronic and/or recurrent in the 3 months following a DU occurrence) active ischemic digital ulcers in patients with systemic sclerosis in a 16 weeks placebo- controlled trial.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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)- 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.
排除标准
- •Patient participating in a clinical trial or having participated in a clinical trial within the previous 3 months,
- •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,
- •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 or unable to express consent
- •Vulnerable patient (pregnancy or lactating women, parturients, persons deprived of their liberty by judicial or administrative decision, persons undergoing psychiatric treatment, persons admitted to a health or social establishment for purposes other than research
- •Refusal of the patient to participate in the study.
- •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,
- •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.
- •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,
- •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”,
- •Treatment with disease modifying agents such as methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, Interferons and cyclophosphamide, within one month prior injection
- •Treatment with oral corticosteroids (> 10 mg/day of prednisone or equivalent),
- •Surgical sympathectomy of the upper limbs or surgical wound debridement within 1 month prior to “inclusion visit”,
结局指标
主要结局
Proportion of refractory active ischemic digital ulcers healed (complete or partial) without recurrence at 16 weeks. The main evaluation criterion is a composite endpoint combining healing (complete or partial) without recurrence at 16 weeks and without local or general complications.
Proportion of refractory active ischemic digital ulcers healed (complete or partial) without recurrence at 16 weeks. The main evaluation criterion is a composite endpoint combining healing (complete or partial) without recurrence at 16 weeks and without local or general complications.
次要结局
未报告次要终点
研究者
clinical research assistant
Scientific
Centre Hospitalier Universitaire De Toulouse
研究点 (7)
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