EUCTR2019-003906-28-FR进行中（未招募）1 期
Subcutaneous injections of autologous cultured adipose-derived stroma/stem cells to heal refractory ischemic digital ulcers in patients with scleroderma : a phase II study - ADUSE
CHU de Toulouse0 个研究点目标入组 32 人开始时间: 2019年11月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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)
- •- 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
排除标准
- •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.
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