NCT03362424

Mesenchymal Stem Cells in Rotator Cuff Repair

Mesenchymal Stem Cells in Rotator Cuff Repair - a Randomized Prospective Study

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Accepted

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).

Detailed description

Rotator cuff tendinopathy is the main cause of shoulder pain and tear of these tendons affects 20% of the population. Although arthroscopic repair leads to satisfactory clinical results, the retear rates varies from 4 to 94%. The main cause of failure after rotator cuff repair is not related to the material used, but to the tissue deficiency and the healing process between the tendon and the bone. After the intervention, the rotator cuff does not restore its original histological characteristics and its fixation occurs through scar tissue with lower biomechanical resistance. There are few clinical studies on the use of mesenchymal cells in rotator cuff repair,, with good results. The investigators will perform a 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

Type	Name	Description
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

Timeline

• Start date: 2020-11-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2017-12-05
• Last updated: 2022-10-19

Locations

1 site across 1 country: Brazil