Utilization of AMSC to Enhance Rotator Cuff Repair - Safety and Efficacy
Status:
Terminated
Trial end date:
2015-11-18
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Bioinova, s.r.o.
Collaborator:
Department of Neurology, University Hospital Motol, Prague, Czech Republic