Mesenchymal Stem Cells in Rotator Cuff Repair

• ClinicalTrials.gov Identifier: NCT03362424
• Recruitment Status: Suspended
• First Posted: December 5, 2017
• Last Update Posted: October 19, 2022
• Sponsor: University of Sao Paulo
• Information provided by (Responsible Party): Eduardo Angeli Malavolta, University of Sao Paulo

Tracking Information

• First Submitted Date: November 29, 2017
• First Posted Date: December 5, 2017
• Last Update Posted Date: October 19, 2022
• Actual Study Start Date: November 1, 2020
• Estimated Primary Completion Date: December 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 4, 2017)

MRI integrity [ Time Frame: 6 months ]

Sugaya classification

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 4, 2017)

• American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) [ Time Frame: 6, 12 and 24-months ]
  minimum 0 points, maximum 100 points. Higher values are considered best outcomes.
• University at California at Los Angeles Shouder Rating Scale (UCLA) [ Time Frame: 6, 12 and 24-months ]
  minimum 3 points, maximum 35 points. Higher values are considered best outcomes.
• Visual Analog Scale for Pain (VAS) [ Time Frame: 6, 12 and 24-months ]
  miminum 0 points, maximum 10 points. Higher values are considered worst outcomes.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Mesenchymal Stem Cells in Rotator Cuff Repair
• Official Title: Mesenchymal Stem Cells in Rotator Cuff Repair - a Randomized Prospective Study
• 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).

• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized controlled trial

Masking: Single (Outcomes Assessor)
Masking Description:

Surgeon and patients not blinded

Primary Purpose: Treatment

Condition

• Rotator Cuff Tear
• Tendon Injuries
• Mesenchymal Stem Cell

Intervention

• 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

Study Arms

• Experimental: Mesenchymal stem cell group
  rotator cuff repair stem cells
  Interventions:

  • Biological: Mesenchymal stem cell
  • Procedure: Rotator cuff repair
• Active Comparator: Control group
  rotator cuff repair
  Intervention: Procedure: Rotator cuff repair

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Suspended
• Estimated Enrollment (submitted: December 4, 2017): 44
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 1, 2023
• Estimated Primary Completion Date: December 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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
• 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.

Exclusion Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 35 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT03362424
• Other Study ID Numbers: 2.335.243
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Eduardo Angeli Malavolta, University of Sao Paulo
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Sao Paulo
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: EDUARDO ANGELI MALAVOLTA A Malavolta, PhD; MD, PhD, Associate Professor

• PRS Account: University of Sao Paulo
• Verification Date: October 2022