NCT05934825招募中1 期
A Multicenter Phase I/II Clinical Trial, Randomized, Double Blind, Controlled With Placebo to Evaluate Safety and Efficiency of Allogenic Adult Mesenchymal Stem Cells From Adipose Tissue in the Treatment of Draining Fistulas in Patients With Hidradenitis Suppurativa
Andalusian Network for Design and Translation of Advanced Therapies2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年10月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate
研究概览
简要总结
Multicenter Phase I/II Clinical Trial to Evaluate Safety and Efficiency of Allogenic Adult Mesenchymal Stem Cell from Adipose Tissue in Patients With Hidradenitis Suppurativa
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who give informed consent for participation in the clinical trial
- •Diagnosed 6 months before inclusion
- •Drainage fistula with a minimum of 1 subcutaneous tract and 1 cutaneous drainage orifice evaluated clinically and by cutaneous ultrasound. The fistula must have active drainage 4 weeks prior to inclusion
- •Treatment with Adalimumab for at least 12 weeks.
- •Normal renal function or moderate chronic renal insufficiency with creatinine clearance values greater than 60 ml/min or serum creatinine less than 1.5 times the upper limit.
- •Normal liver function with total bilirubin values less than 1.5 times the upper limit of normal and transaminases < 2.5 times the upper limit of normal.
- •Hemogram and coagulation studies within normal values (Leukocytes ≥ 3000, Neutrophils ≥ 1500, Platelets ≥ 100000, hemoglobin>10g/dl).
- •Negative blood pregnancy test for patients of childbearing age
- •Acceptance by the patient, of childbearing age, to use safe contraceptive methods throughout the study, including six months of follow-up.
- •Willingness and ability to comply with the visit schedule, treatment plan, clinical tests and all study procedures. and all study procedures.
排除标准
- •Poorly controlled HS requiring additional systemic treatment or change of baseline anti-inflammatory therapy
- •Abscess or inflammatory collection > 2 cm adjacent to the fistula to be treated.
- •Previous surgical treatment on the draining fistula
- •Known history of alcohol abuse in the 6 months prior to study entry
- •Active malignancy or patients with a history of a previous malignant tumor.
- •Presence or recent history of severe, progressive and uncontrolled hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, psychiatric or skin disease
- •Congenital or acquired immunodeficiencies
- •Positive serology for HIV, HCV or HBV.
- •Active COVID-19 infection confirmed by serology and PCR or rapid antigen test
- •Allergy to any of the components/excipients of the Investigational Product
- •Major surgery or severe trauma in the previous 6 months
- •Patients unwilling or unable to comply with study procedures.
- •Anticipated need for surgery in the anatomical area for a reason other than hidradenitis suppurative
- •Contraindication to the anesthetic procedure
- •Systemic immunomodulatory biologic therapy other than Adalimumab, topical or systemic antibiotics for HS, systemic or intralesional corticosteroids, live vaccines, or any experimental treatment or intervention study participation.
- •Contraindication of nuclear magnetic resonance with contrast.
- •Women who are pregnant, breastfeeding, or of childbearing age who are not using an effective contraceptive method.
- •Patients who are currently participating or have completed participation in a clinical trial in a period of less than 3 months or who have participated in an Advanced Therapies clinical trial at any previous time and have been assigned to an experimental group.
结局指标
主要结局
Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate
时间窗: 23 months
To evaluate the efficacy of intralesional administration of human allogeneic mesenchymal cells versus the control group, in terms of combined remission of the draining fistula.
Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate
时间窗: 24 months
To determine the safety of intralesional administration of allogeneic mesenchymal cells in draining fistulas in patients with hidradenitis suppurativa
次要结局
未报告次要终点
研究者
研究点 (2)
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