Mesenchymal Stem Cells in Rotator Cuff Repair

Rotator Cuff Tear Clinical Trial

Official title:

Mesenchymal Stem Cells in Rotator Cuff Repair - a Randomized Prospective Study

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03362424
• Other study ID #: 2.335.243
• Status: Suspended
• Phase: Phase 2
• Start date: November 1, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: October 2022
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 scale (VAS).

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).

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 44
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mesenchymal Stem Cell
• Rotator Cuff Injuries
• Rotator Cuff Tear
• Tendon Injuries

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

Locations

Country	Name	City	State
Brazil	Universidade de São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI integrity	Sugaya classification	6 months
Secondary	American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)	minimum 0 points, maximum 100 points. Higher values are considered best outcomes.	6, 12 and 24-months
Secondary	University at California at Los Angeles Shouder Rating Scale (UCLA)	minimum 3 points, maximum 35 points. Higher values are considered best outcomes.	6, 12 and 24-months
Secondary	Visual Analog Scale for Pain (VAS)	miminum 0 points, maximum 10 points. Higher values are considered worst outcomes.	6, 12 and 24-months