drugset / Trial / NCT03838666

Utilization of AMSC to Enhance Rotator Cuff Repair - Safety and Efficacy

NCT03838666 ↗

Phase 1/2 Terminated 9 enrolled Bioinova, s.r.o. University Hospital, Motol · collab
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

EvaluationDrugModalityDoseRoute
Subject MSC 3P Cell therapy 1.5 ml Other

Indications