Mesenchymal Stem Cells in Rotator Cuff Repair

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

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 Overview

• Status: Suspended
• Conditions: Rotator Cuff Tear; Tendon Injuries; Mesenchymal Stem Cell
• Intervention / Treatment: Biological: Mesenchymal stem cell; Procedure: Rotator cuff repair

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
• Enrollment (Anticipated): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05403-010
      • Universidade de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI integrity	Sugaya classification	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Visual Analog Scale for Pain (VAS)	miminum 0 points, maximum 10 points. Higher values are considered worst outcomes.	6, 12 and 24-months

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: EDUARDO ANGELI MALAVOLTA A Malavolta, PhD, MD, PhD, Associate Professor

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: November 29, 2017
• First Submitted That Met QC Criteria: December 4, 2017
• First Posted (ACTUAL): December 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Rotator Cuff Injuries; Tendon Injuries
• Other Study ID Numbers: 2.335.243

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No