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Mesenchymal Stem Cells in Rotator Cuff Repair

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ClinicalTrials.gov Identifier: NCT03362424
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Eduardo Angeli Malavolta, University of Sao Paulo

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).

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Tendon Injuries Mesenchymal Stem Cell Biological: Mesenchymal stem cell Procedure: Rotator cuff repair Phase 2

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  (Clinical Trial)
Estimated Enrollment : 44 participants
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
Official Title: Mesenchymal Stem Cells in Rotator Cuff Repair - a Randomized Prospective Study
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : December 1, 2022

Arm Intervention/treatment
Experimental: Mesenchymal stem cell group
rotator cuff repair stem cells
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

Active Comparator: Control group
rotator cuff repair
Procedure: Rotator cuff repair
Rotator cuff repair




Primary Outcome Measures :
  1. MRI integrity [ Time Frame: 6 months ]
    Sugaya classification


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362424


Contacts
Contact: Eduardo A Malavolta, PhD +5511998329862 eduardomalavolta@gmail.com
Contact: Thais P Vasques +5511 2661-2486 thaiscpvasques@gmail.com

Locations
Brazil
Universidade de São Paulo Recruiting
São Paulo, SP, Brazil, 05403-010
Contact: Eduardo A Malavolta, PhD    +5511998329862    eduardomalavolta@gmail.com   
Contact: Thais Vasques    +551126612486    thaiscpvasques@gmail.com   
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: EDUARDO ANGELI MALAVOLTA A Malavolta, PhD MD, PhD, Associate Professor

Responsible Party: Eduardo Angeli Malavolta, Principal investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03362424     History of Changes
Other Study ID Numbers: 2.335.243
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Rotator Cuff Injuries
Tendon Injuries
Rupture
Wounds and Injuries
Shoulder Injuries