drugset / Trial / NCT02918136
Safety and Efficacy Adipose-Derived Stem Cell Injection Partial Thickness Rotator Cuff Tears
RandomizedParallel-groupSingle-blindTreatment
Summary
This is a prospective, randomized, multi-site, safety and efficacy study in subjects with rotator cuff injuries. Patients will fall into two categories: treatment group (12 subjects) and non-treatment or control group (six subjects). The treatment group will undergo a small liposuction procedure and receive rotator cuff repair treatment with an ultrasound-guided injection of 5cc adipose-derived stem cells (ADSCs) into the point of injury. The control group will receive a 5cc cortisone injection into the point of injury
Timeline
- Start
- 2016-12
- Primary completion
- 2018-07-31
- Completion
- 2018-12-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cortisone acetate | Other / unclassified | — | Other |
| Subject | adipose-derived regenerative cells | Cell therapy | 5 ml | Other |