drugset / Trial / NCT03838666
Utilization of AMSC to Enhance Rotator Cuff Repair - Safety and Efficacy
NaSingle-groupOpen-labelTreatment
Summary
Subjects received perioperative hAMSC treatment in order to accelerate the healing of the surgically repaired rotator cuff and increase the mechanical properties of the tendon, according to inclusion and exclusion criteria (see below). Each patient will undergo post-operative follow-up at 6 weeks, 6 months and 12 months after the surgery. This will include a visual analogue score for pain (VAS), a questionnaire for the subjective Constant shoulder score, and the subjective questions of the University of California (UCLA) score. Preoperative and postoperative MRI at 12 months will be done to evaluate the quality of the rotator cuff repair.
Timeline
- Start
- 2012-12-12
- Primary completion
- 2015-11-18
- Completion
- 2015-11-18
Outcome
Outcome not reported
Stopped: “Primary endpoint (safety) has been achieved”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MSC 3P | Cell therapy | 1.5 ml | Other |