Double-blind, Placebo Controlled, Multi-center Safety and Feasibility Study in Patients With Documented Grade II Hamstring Tears Treated With Intramuscularly Delivered Adipose Derived Regenerative Cells - RECOVER
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- AE and SAE Monitoring
研究概览
简要总结
To evaluate the safety and feasibility of adipose-derived regenerative cells injected into tears of the hamstring muscle.
详细描述
The RECOVER Clinical Trial is a prospective, randomized, multi-center device trial intended to assess safety and feasibility, and inform dose selection in preparation for a pivotal trial. Subjects that have Grade II tears of the hamstring will be evaluated for eligibility in this study.
Part A of the trial will be an open-label, safety, feasibility and dose-escalation study to assess whether the treatment approach (liposuction, cell processing and injection) is feasible in athletic patients at one or both doses of ADRCs.
Part B of the trial is contingent on successful completion of Part A and is a multicenter, randomized, double blind trial of both doses of ADRCs vs. placebo.
In both parts of the study, following informed consent and screening evaluations, eligible subjects will undergo pre-operative testing. Subjects will then undergo liposuction under general or local anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs for immediate intramuscular administration under ultrasound guidance.
The first 5 patients of Part A will receive 0.2 million cells/kg body weight (maximum of 20 million cells) while the second 5 patients will receive 0.4 million cells/kg body weight (maximum of 40 million cells).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Grade II tears (≥5%) of the hamstring
- •Weakness or inability to use affected muscle
- •Ability to safely undergo liposuction
排除标准
- •Tears restricted to the ligament (i.e. no muscle tear)
- •Known spine or disc disease or sciatic nerve disease
- •Known neuromuscular disease
- •Pregnant or lactating status
- •Any condition requiring immunosuppressive medication or use of systemic steroids
- •Known history of HIV, or has active Hepatitis B or active Hepatitis C
- •Cancer requiring chemotherapy or resection within the last 5 years (other than basal cell carcinoma)
结局指标
主要结局
AE and SAE Monitoring
时间窗: Follow up period (Up to 24 Months)
AE and SAE Monitoring
次要结局
- Change in pain and function(Baseline to Completion (Up to 24 months))
- Change in lesion size(Baseline to Completion (Up to 24 months))
- Change in muscle strength(Follow up to Completion ((Up to 24 Months))