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

NCT03838666 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2019-02-15

No results posted yet for this study

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.

Conditions

  • Rotator Cuff Tear

Interventions

DRUG

Suspension of human autologous MSC 3P

Single administration of the suspension of human autologous MSC 3P in 1.5 ml on the surface of the repaired rotator cuff tendon

Sponsors & Collaborators

  • University Hospital, Motol

    collaborator OTHER

  • Bioinova, s.r.o.

    lead INDUSTRY

Principal Investigators

  • Petr Lesny, MD · Bioinova, s.r.o.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-12
Primary Completion
2015-11-18
Completion
2015-11-18

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03838666 on ClinicalTrials.gov