A Longitudinal, Multi-Center Safety Study of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 246
- 试验地点
- 11
- 主要终点
- Primary Endpoint- Safety
研究概览
简要总结
This is a longitudinal follow-up study of the RC-002 study, in which up to 246 subjects assigned to two randomization arms will be enrolled: an adipose-derived regenerative cell (ADRC) injection arm (ADRC treatment arm) and the SOC corticosteroid injection arm (active control arm). All subjects will be randomly assigned to ADRC treatment or active control arms in a 2:1 ratio and will be followed up for 6 months.
The goal of the RC-004 study is to enroll all patients that were enrolled and treated in RC-002 and follow for 3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Subjects must have completed RC-
- •2. Subjects can give appropriate consent.
排除标准
- •1. Subjects who require the use of index arm for ambulation or mobilization via wheelchair, walker, crutches or cane.
- •2. Subjects whose pain behavior or pain medication usage is, in the opinion of the Investigator, out of proportion to the underlying clinical condition or could interfere with the study-required assessments.
- •3. Subject is on an active regimen of chemotherapy or radiation-based treatment.
- •4. Subject is part of a vulnerable population who, in the judgment of the Investigator, is unable to give informed consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with a mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.
- •5. Uncooperative subjects or those with neurological/psychiatric disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
研究组 & 干预措施
Adipose Derived Regenerative Cells
a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear
干预措施: Adipose Derived Regenerative Cells (Device)
Corticosteroid
a single corticosteroid injection into the subacromial space of the index arm
干预措施: Corticosteroid (Device)
结局指标
主要结局
Primary Endpoint- Safety
时间窗: 12 months
Incidence (%) severity and seriousness of adverse events (AEs)
次要结局
- Percentage of subjects who demonstrate ≥ 14 mm improvement in VAS - Pain score compared to baseline(12 months)
- Mean improvement in VAS - Pain score compared to baseline(12 months)
- Percentage of subjects who demonstrate improvement or no worsening of supraspinatus strength on the MRC Muscle Scale compared to baseline(12 months)
- Mean improvement in WORC score compared to baseline(12 months)