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Mesenchymal Stem Cells in Rotator Cuff Repair

Primary Purpose

Rotator Cuff Tear, Tendon Injuries, Mesenchymal Stem Cell

Status
Suspended
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Mesenchymal stem cell
Rotator cuff repair
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mesenchymal stem cell group

Control group

Arm Description

rotator cuff repair stem cells

rotator cuff repair

Outcomes

Primary Outcome Measures

MRI integrity
Sugaya classification

Secondary Outcome Measures

American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
minimum 0 points, maximum 100 points. Higher values are considered best outcomes.
University at California at Los Angeles Shouder Rating Scale (UCLA)
minimum 3 points, maximum 35 points. Higher values are considered best outcomes.
Visual Analog Scale for Pain (VAS)
miminum 0 points, maximum 10 points. Higher values are considered worst outcomes.

Full Information

First Posted
November 29, 2017
Last Updated
October 17, 2022
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03362424
Brief Title
Mesenchymal Stem Cells in Rotator Cuff Repair
Official Title
Mesenchymal Stem Cells in Rotator Cuff Repair - a Randomized Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Suspended
Why Stopped
Cryogenesis company stopped supplying mesenchymal cells
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear, Tendon Injuries, Mesenchymal Stem Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Masking Description
Surgeon and patients not blinded
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mesenchymal stem cell group
Arm Type
Experimental
Arm Description
rotator cuff repair stem cells
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
rotator cuff repair
Intervention Type
Biological
Intervention Name(s)
Mesenchymal stem cell
Intervention Description
Mesenchymal stem cells applies at the end of rotator cuff repair in de active group
Intervention Type
Procedure
Intervention Name(s)
Rotator cuff repair
Intervention Description
Rotator cuff repair
Primary Outcome Measure Information:
Title
MRI integrity
Description
Sugaya classification
Time Frame
6 months
Secondary Outcome Measure Information:
Title
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
Description
minimum 0 points, maximum 100 points. Higher values are considered best outcomes.
Time Frame
6, 12 and 24-months
Title
University at California at Los Angeles Shouder Rating Scale (UCLA)
Description
minimum 3 points, maximum 35 points. Higher values are considered best outcomes.
Time Frame
6, 12 and 24-months
Title
Visual Analog Scale for Pain (VAS)
Description
miminum 0 points, maximum 10 points. Higher values are considered worst outcomes.
Time Frame
6, 12 and 24-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EDUARDO ANGELI MALAVOLTA A Malavolta, PhD
Organizational Affiliation
MD, PhD, Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade de São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-010
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Mesenchymal Stem Cells in Rotator Cuff Repair

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