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Trial record 1 of 5 for:    stem cells | Recruiting, Not yet recruiting, Available Studies | "Shoulder injuries" AND "Shoulder Injuries"
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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 : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Eduardo Angeli Malavolta, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE November 29, 2017
First Posted Date  ICMJE December 5, 2017
Last Update Posted Date November 4, 2020
Estimated Study Start Date  ICMJE November 1, 2020
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2017)
MRI integrity [ Time Frame: 6 months ]
Sugaya classification
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mesenchymal Stem Cells in Rotator Cuff Repair
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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  ICMJE
  • Rotator Cuff Tear
  • Tendon Injuries
  • Mesenchymal Stem Cell
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 4, 2017)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2022
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Eduardo A Malavolta, PhD +5511998329862 eduardomalavolta@gmail.com
Contact: Thais P Vasques +5511 2661-2486 thaiscpvasques@gmail.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03362424
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: Undecided
Responsible Party Eduardo Angeli Malavolta, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: EDUARDO ANGELI MALAVOLTA A Malavolta, PhD MD, PhD, Associate Professor
PRS Account University of Sao Paulo
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP