Mesenchymal Stem Cells in Rotator Cuff Repair

NCT ID: NCT03362424

Last Updated: 2022-10-19

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2023-12-01

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).

Conditions

Rotator Cuff Tear; Tendon Injuries; Mesenchymal Stem Cell

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mesenchymal stem cell group

rotator cuff repair stem cells

Group Type: EXPERIMENTAL

Mesenchymal stem cell

Intervention Type: BIOLOGICAL

Mesenchymal stem cells applies at the end of rotator cuff repair in de active group

Rotator cuff repair

Intervention Type: PROCEDURE

Rotator cuff repair

Control group

rotator cuff repair

Group Type: ACTIVE_COMPARATOR

Rotator cuff repair

Intervention Type: PROCEDURE

Rotator cuff repair

Interventions

Mesenchymal stem cell

Mesenchymal stem cells applies at the end of rotator cuff repair in de active group

Intervention Type: BIOLOGICAL

Rotator cuff repair

Rotator cuff repair

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Eduardo Angeli Malavolta

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

EDUARDO ANGELI MALAVOLTA A Malavolta, PhD

Role: PRINCIPAL_INVESTIGATOR

MD, PhD, Associate Professor

Locations

Universidade de São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

2.335.243

Identifier Type: -

Identifier Source: org_study_id