NCT02104713已完成1 期
A Pilot Safety Study of the Administration of Mesenchymal Stem Cells (MSC) in the Treatment of Burn Wounds
E.Badiavas2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2014年6月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Monitoring for adverse events as Assessed by CTCAE v4.0 following administration of allogeneic MSCs to 2nd degree burn wounds.
研究概览
简要总结
This study will determine the safety of allogeneic stem cell therapy from healthy donors, for 2nd degree burn wounds of less than 20% Total Body Surface Area (TBSA), at four different dose levels.
Clinical evaluation will take place every 1 to 4 weeks intervals until wound closure, and then monthly for 6 months following the last administration of MSCs.
Once the safety and dose-response analysis in Phase 1 is completed, an expanded trial will be initiated to better examine the efficacy of MSC therapy in 2nd degree burn wounds. Phase 1 will establish the maximum safe dose that will be used in the Phase II trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects 18 years of age or older with Superficial, Intermediate or Deep 2nd Degree Burn Wounds
- •Injury within the prior 7 days
- •Subjects must understand and give written informed consent.
- •Subjects must agree to have biopsies performed as per protocol
- •Subjects must be accessible for weekly wound treatment and assessment visits
- •Males and females must agree to use an acceptable method of contraception. Exceptions will be females of non-childbearing age and monogamous males who are partners of females of non-childbearing age. Acceptable methods of birth control include; history of sterilization, birth control pills, depoprogesterone injections, a barrier contraceptive such as a condom with or without spermicide cream or gel, diaphragms or cervical cap with or without spermicide cream or gel, or an intrauterine device (IUD).
- •Maximum wound size limited to:
- •Single wound: ≤ 5% body surface area (BSA)
- •Multiple wounds treated in a defined anatomical region with ≤ 20% cumulative BSA.
- •Diabetic subjects: HbA1c ≤ 8%
排除标准
- •Solely 1st degree or solely 3rd degree burns
- •Subjects with superficial 2nd degree burn who are expected to heal within 2 weeks post standard therapy
- •Evidence of active infection at the wound site
- •Evidence of significant wound healing prior to treatment
- •Wound located in the area of fingers, toes, face, or perineum
- •Wound where 75% or more extends across joints
- •Electrical or chemical burns
- •Have any requirement for the use of systemic steroids or immunosuppressive
- •Subjects Allergic to human albumin, streptomycin, or penicillin
- •Be a pregnant female or nursing mother
- •Subjects who are known or found to be HIV positive
- •Current history of alcohol or substance abuse or history of alcohol or substance abuse requiring treatment within the past 12 months
- •Patients with severe medical conditions
- •Malignancy (other than non melanoma skin cancer) not in remission or in remission less than 5 years
- •Life expectancy less than two years
- •Severe cardiopulmonary disease restricting ambulation to the clinical facility
- •WBC <3 or > 10 x10⁹/L, Hgb < 9g/dL, platelets count 100x10⁹/L or less, serum creatinine > 1.5 times the upper normal limit, AST or ALT > 2.5 times the upper normal limit.
- •Subjects with abnormal bilirubin levels.
- •Subjects with abnormal PT/INR laboratory values while not on chronic anticoagulant treatment which can be held for minor surgical procedures
- •Those with a known history of coagulopathy
- •Subjects who are potential recipients of tissue or organ transplantation
- •Subjects with circulating Hepatitis B antigen and/or who are seropositive for Hepatitis C antibody
- •History of poor compliance, unreliability
结局指标
主要结局
Monitoring for adverse events as Assessed by CTCAE v4.0 following administration of allogeneic MSCs to 2nd degree burn wounds.
时间窗: 1.5 years
The study will consist of a dose escalation phase consisting of four dose levels. Each dose level will compare the safety of administering allogeneic MSCs, with 5 patients per group.
次要结局
未报告次要终点
研究者
E.Badiavas
Professor of Dermatology & Cutaneous Surgery
University of Miami
研究点 (2)
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