Ignite Creation Date:
2024-05-06 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03362424
Status:
SUSPENDED
Last Update Posted:
2022-10-19
First Post:
2017-11-29
Brief Title:
Mesenchymal Stem Cells in Rotator Cuff Repair
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
Mesenchymal Stem Cells in Rotator Cuff Repair - a Randomized Prospective Study
Status:
SUSPENDED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Cryogenesis company stopped supplying mesenchymal cells
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None