NCT00620737撤回2 期
Pilot Safety and Efficacy Study of Isolagen Therapy in Treatment of Restrictive Burn Scars
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 6
- 主要终点
- Change from baseline of all study assessments
研究概览
简要总结
The purpose of this study is to evaluate the safety profile and the treatment effect of Isolagen TherapyTM and placebo when administered to stable restrictive burn scars of an affected joint area.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is at least 18 years of age
- •Subject has "stable" restrictive burn scar of a jointed area that restricts range of motion (ROM) of the affected joint by greater than or equal to 20% and that is no deeper than the fascia (i.e., underlying structures including ligament, tendon, muscle, and bone must not contribute to the restriction)
- •Subject agrees to maintain any current physical therapy regimen for the duration of the study
- •Subject must be able to provide written informed consent and comply with the study requirements
- •Females of childbearing potential must have a negative urine pregnancy test at the screening visit and must agree to use a reliable means of birth control for the duration of the study
- •Male subjects must agree to use a reliable means of birth control for the duration of the study
- •Subject has healthy, non-scarred post auricular, abdomen, back of neck at hairline, lower abdomen, upper arm, side of upper leg, or axillary region (on the lateral thorax) skin area suitable for biopsy
- •Subject has normal CBC, thyroid function, renal function, liver function, blood glucose and SMA 18 at Screening
排除标准
- •The restrictive burn scar to be treated is primarily classified as a keloid scar
- •Surgical release of scar to be treated within the last 12 months
- •Subjects for whom a skin biopsy cannot be collected
- •Plans to initiate any new scar therapy during the study period
- •Treatment with an investigational product or procedure within 30 days prior to study enrollment or plans to participate in another clinical trial during the course of this study
- •History of active autoimmune disease or organ transplantation
- •Diagnosis of cancer, including basal cell carcinoma, unless successfully treated or in remission for a minimum of 6 months
- •Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, epidermolysis bullosa, ataxia-telangiectasia, or Ehlers Danlos syndrome
- •Active systemic infection as shown by any one of the following: symptoms, fever and/or an elevated white count (subjects who present with an active systemic infection may be enrolled and biopsied after the infection has resolved)
- •Requires chronic antibiotic or steroidal therapy
- •Any conditions that are considered by the Investigator to be contraindications to biopsy or injection
- •Pregnant or lactating women or women trying to become pregnant during the study
- •Subject has any disorder that may prevent compliance, such as history of chronic alcohol or drug abuse, significant mental or nervous disorder or other illness that would, in the Investigator's opinion, interfere with the study
- •Presence of other disease or condition that would result in impairment of the range of motion of the extremity, e.g. rheumatoid arthritis or stroke
- •Subjects with a known allergy to gentamycin or amphotericin B, or sensitivity to materials of bovine origin
结局指标
主要结局
Change from baseline of all study assessments
时间窗: Day 0, 14, 30, 60, 90 and 120
次要结局
- Review of adverse Events, vital signs and physical examination(Day 0, 14, 30, 60, 90 and 120)
研究者
研究点 (6)
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