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Mesenchymal Stem Cells in Rotator Cuff Repair

NCT03362424 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2022-10-19

No results posted yet for this study

Summary

Randomized clinical study involving 44 patients, evaluating the effect of mesenchymal cells on rotator cuff repair. The primary outcome will be post-operative MRI tendon integrity and secondary outcomes clinical assessment by the UCLA and American Shoulder and Elbow Surgeons (ASES) scales and pain by visual analog scale (VAS).

Conditions

  • Rotator Cuff Tear
  • Tendon Injuries
  • Mesenchymal Stem Cell

Interventions

BIOLOGICAL

Mesenchymal stem cell

Mesenchymal stem cells applies at the end of rotator cuff repair in de active group

PROCEDURE

Rotator cuff repair

Rotator cuff repair

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • EDUARDO ANGELI MALAVOLTA A Malavolta, PhD · MD, PhD, Associate Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2023-12-01
Completion
2023-12-01

Countries

  • Brazil

Study Locations

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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 NCT03362424 on ClinicalTrials.gov