Rotator Cuff TearPhase 2NCT03362424
Mesenchymal Stem Cells in Rotator Cuff Repair
A Phase 2 study testing Mesenchymal stem cell and Rotator cuff repair in people with Rotator Cuff Tear and Tendon Injuries, run by University of Sao Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tear, Tendon Injuries, Mesenchymal Stem Cell
- What is being tested?
- Mesenchymal stem cell and Rotator cuff repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2020to 1 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Full thickness posterosuperior rotator cuff tear, of small or medium size, fully repairable at the time of surgery, regardless of size;
- Pain and / or decreased shoulder function for at least 3 months, with no improvement with non-surgical treatment;
- Absence of the following changes in MRI:
- Fat degeneration of the rotator cuff musculature of grade 3 according to the classification of Fuchs (presence of equal or superior amount of fat compared to muscle fibers);
- Absence of the following changes in radiographs
- Advanced glenohumeral arthrosis (grades 2, 3 and 4 of Samilson and Prieto
Show all 19Show fewer
- Signs of rotator cuff arthropathy, according to Seebauer classification;
- Skeletal maturity;
- Absence of surgeries or previous fractures in the shoulder in question;
- Absence of psychiatric illnesses, fibromyalgia or painful pathologies of the cervical spine;
- Absence of rheumatic diseases or chronic use of corticosteroids;
- Absence of active or recent infection;
- Absence of thrombocytopenia, coagulopathies or chronic use of anticoagulants;
- Absence of vascular or neurological lesions affecting the upper limb;
- Absence of pregnancy;
- Clinical non-compensated comorbidities;
- Chronic use of corticosteroids;
- Consent to free and informed consent;
- Live in Brazil.
Who cannot join
- Visualization during the operative event of one or more of the findings:
- Irreparable rupture of rotator cuff;
- Subsecapularis tear involving two thirds or more of its extension;
- Need to open surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mesenchymal Stem Cells in Rotator Cuff Repair - a Randomized Prospective Study
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).
Read the 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
- Being tested
- Mesenchymal stem cell, Rotator cuff repair
- Medical subject headings
- Rotator Cuff Injuries, Tendon Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stem cellBiological
Mesenchymal stem cells applies at the end of rotator cuff repair in de active group
Rotator cuff repairProcedure or surgery
Rotator cuff repair
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cell group | Experimental | rotator cuff repair stem cells Receives: Biological: Mesenchymal stem cell; Procedure: Rotator cuff repair |
| Control group | Active comparator | rotator cuff repair Receives: Procedure: Rotator cuff repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI integrity
Sugaya classification
Measured: 6 months
Secondary outcomes (3)
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
minimum 0 points, maximum 100 points. Higher values are considered best outcomes.
Measured: 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.
Measured: 6, 12 and 24-months
Visual Analog Scale for Pain (VAS)
miminum 0 points, maximum 10 points. Higher values are considered worst outcomes.
Measured: 6, 12 and 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start1 Nov 2020
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Why it stopped: Cryogenesis company stopped supplying mesenchymal cells
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Angeli Malavolta, University of Sao Paulo
- Investigators
- EDUARDO ANGELI MALAVOLTA A Malavolta, PhD, Principal investigator, MD, PhD, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362424
- Sponsor's protocol ID
- 2.335.243
- Status last verified
- Oct 2022
- First submitted
- 29 Nov 2017
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesenchymal Stem Cells in Rotator Cuff Repair - a Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT03362424
- Acronym / sponsor ID
- 2.335.243
- Conditions
- Rotator Cuff Tear, Tendon Injuries, Mesenchymal Stem Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Cryogenesis company stopped supplying mesenchymal cells
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cell group | Experimental | Biological: Mesenchymal stem cell, Procedure: Rotator cuff repairrotator cuff repair stem cells |
| Control group | Active comparator | Procedure: Rotator cuff repairrotator cuff repair |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Full thickness posterosuperior rotator cuff tear, of small or medium size, fully repairable at the time of surgery, regardless of size;
- Pain and / or decreased shoulder function for at least 3 months, with no improvement with non-surgical treatment;
- Absence of the following changes in MRI:
- Fat degeneration of the rotator cuff musculature of grade 3 according to the classification of Fuchs (presence of equal or superior amount of fat compared to muscle fibers);
- Absence of the following changes in radiographs
Key exclusion criteria (4 listed)
- Visualization during the operative event of one or more of the findings:
- Irreparable rupture of rotator cuff;
- Subsecapularis tear involving two thirds or more of its extension;
- Need to open surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesenchymal stem cellMesenchymal stem cells applies at the end of rotator cuff repair in de active group | Biological | Mesenchymal stem cell group |
| Rotator cuff repairRotator cuff repair | Procedure or surgery | Control group, Mesenchymal stem cell group |
Primary outcome
MRI integrity
Time frame: 6 months
Sugaya classification
3 secondary outcomes
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
Time frame: 6, 12 and 24-months
University at California at Los Angeles Shouder Rating Scale (UCLA)
Time frame: 6, 12 and 24-months
Visual Analog Scale for Pain (VAS)
Time frame: 6, 12 and 24-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EDUARDO ANGELI MALAVOLTA A Malavolta, PhD principal investigator
MD, PhD, Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mesenchymal stem cell and Rotator cuff repair in people with Rotator Cuff Tear and Tendon Injuries, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI integrity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.