A Phase II, Double-Blind, Randomized, Placebo-Controlled Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 18
- 主要终点
- Percentage Change From Baseline (CFB) of Range of Motion (ROM) of the Affected Joint
研究概览
简要总结
This Phase II, double-blind, randomized, placebo-controlled pilot study is designed to determine whether injection of autologous fibroblasts can increase the mobility (decrease the restriction) of burn scars. The study will assess the effects of azficel-T (autologous fibroblasts) in subjects who have a unilateral burn scar that is no deeper than the fascia (i.e., underlying structures including ligament, tendon, muscle, and bone must not contribute to the restriction) and that is either:
- An axillary scar causing 20-60% restriction of shoulder adduction
- An anterior elbow scar causing 20-60% restriction of elbow extension
- A dorsal or palmar lesion of a single finger causing 20-60% restriction of flexion or extension
Subjects will each receive 2 injections of azficel-T or placebo administered 14 days (± 7 days) apart (depending on cell availability) and will be followed for efficacy (including range of motion measurements, scar pain and ability to perform activities) to Visit 7 and for safety to Visit 9 at 1 year.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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 a unilateral burn scar of a jointed area (i.e., finger, elbow, shoulder) that is no deeper than the fascia (i.e., underlying structures including ligament, tendon, muscle, and bone must not contribute to the restriction) and that is either:
- •An axillary scar causing 20-60% restriction of shoulder abduction
- •An anterior elbow scar causing 20-60% restriction of elbow extension
- •A dorsal or palmar lesion of a single finger causing 20-60% restriction of flexion or extension
- •Subject's burn scar to be treated is <100 sq cm in size
- •Injury occurred ≤ 36 months prior to screening
- •By the Investigator's assessment, physical therapy will not provide significant continuous improvement to the range of motion of the subject's joint
- •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 prior to the first treatment, and must agree to use a reliable means of birth control for the duration of the study
- •Subject has healthy, non-scarred post auricular skin area suitable for biopsy
- •Subject must have a normal complete blood count (CBC) and chemistry panel within 90 days prior to enrollment
排除标准
- •Restrictive burn scars that are primarily classified as keloid scars
- •Subjects for whom a post auricular biopsy cannot be collected for azficel-T production
- •Sunburn or sun damage in the area that will be used for biopsy
- •Plans to initiate any other 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, Ehlers Danlos syndrome, etc.
- •Active systemic infection
- •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
结局指标
主要结局
Percentage Change From Baseline (CFB) of Range of Motion (ROM) of the Affected Joint
时间窗: Baseline and post-treatment (visit occurred between 194 - 208 days from baseline)
Percentage CFB was calculated by subtracting the baseline ROM measurement from the post-treatment ROM measurement, divided by the baseline ROM measurement, and multiplying by 100.
Percentage CFB of ROM of the Affected Joint
时间窗: Baseline and post-treatment (visit occurred between 113 - 127 days from baseline)
Percentage CFB was calculated by subtracting the baseline ROM measurement from the post-treatment ROM measurement, divided by the baseline ROM measurement, and multiplying by 100.
次要结局
未报告次要终点