A Phase 2 interventional study of Mesenchymal stem cell and Rotator cuff repair in Rotator Cuff Tear, Tendon Injuries and Mesenchymal Stem Cell, sponsored by University of Sao Paulo. Suspended at 1 site in Brazil. Open to participants aged 35 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-19.
Sponsored by University of Sao Paulo · Phase 2, Interventional, and Treatment
Among 10 studies in Rotator Cuff Injuries with a site in Brazil — 1 open to participants now, 1 under way, none of them phase 3. Rotator Cuff Injuries · Brazil.
Among the 10 studies in Rotator Cuff Injuries with a site in Brazil, this one is the 9th largest by planned enrollment, is one of 4 that started in 2020, is the only one in phase 2, and was the 2nd registered.
631 studies on the registry are indexed under Rotator Cuff Injuries; 156 are open to participants now.
Browse Rotator Cuff Injuries studies →1 of the 10 studies in Rotator Cuff Injuries with a site in Brazil is open now. Recruiting first, the newest first:
Federal University of São Paulo · Sites in Brazil
A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →
Of the 100 Rotator Cuff Injuries studies recruiting now, 40 (40%) set no upper age limit and 41 (41%) stop at 75 or younger; 9 take children under 18; 10 take healthy volunteers.
This study: 35 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 4 started in 2020.
This study's planned enrollment of 44 is below the median of 60 across 456 interventional studies indexed under Rotator Cuff Injuries.
Median enrollment 67 across the 10 interventional studies. Of the 5 that completed or were terminated, 0 (0%) have results posted.
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None of the 10 has an industry lead sponsor. The 8 most frequent:
University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
University of Sao Paulo has 2 studies filed under Rotator Cuff Injuries — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Rotator Cuff Injuries with a site in Brazil, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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).
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
rotator cuff repair stem cells
Biological: Mesenchymal stem cell · Procedure: Rotator cuff repair
rotator cuff repair
Procedure: Rotator cuff repair
Mesenchymal stem cells applies at the end of rotator cuff repair in de active group
Rotator cuff repair
MRI integrity
Sugaya classification
Time frame: 6 months
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
minimum 0 points, maximum 100 points. Higher values are considered best outcomes.
Time frame: 6, 12 and 24-months
University at California at Los Angeles Shouder Rating Scale (UCLA)
minimum 3 points, maximum 35 points. Higher values are considered best outcomes.
Time frame: 6, 12 and 24-months
Visual Analog Scale for Pain (VAS)
miminum 0 points, maximum 10 points. Higher values are considered worst outcomes.
Time frame: 6, 12 and 24-months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Nov 2020 (actual). Primary completion is estimated for Dec 2023, 37 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is suspended, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mesenchymal Stem Cell