NCT03362424

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).

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
2.9 years until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

3.1 years

First QC Date

November 29, 2017

Last Update Submit

October 17, 2022

Conditions

Rotator Cuff TearTendon InjuriesMesenchymal Stem Cell

Outcome Measures

Primary Outcomes (1)

  • MRI integrity

    Sugaya classification

    6 months

Secondary Outcomes (3)

  • American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)

    6, 12 and 24-months

  • University at California at Los Angeles Shouder Rating Scale (UCLA)

    6, 12 and 24-months

  • Visual Analog Scale for Pain (VAS)

    6, 12 and 24-months

Study Arms (2)

Mesenchymal stem cell group

EXPERIMENTAL

rotator cuff repair stem cells

Biological: Mesenchymal stem cellProcedure: Rotator cuff repair

Control group

ACTIVE COMPARATOR

rotator cuff repair

Procedure: Rotator cuff repair

Interventions

Mesenchymal stem cellBIOLOGICAL

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

Mesenchymal stem cell group
Rotator cuff repairPROCEDURE

Rotator cuff repair

Control groupMesenchymal stem cell group

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • +4 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade de São Paulo

São Paulo, São Paulo, 05403-010, Brazil

Location

MeSH Terms

Conditions

Rotator Cuff InjuriesTendon Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder Injuries

Study Officials

  • EDUARDO ANGELI MALAVOLTA A Malavolta, PhD

    MD, PhD, Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Surgeon and patients not blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 29, 2017

First Posted

December 5, 2017

Study Start

November 1, 2020

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

October 19, 2022

Record last verified: 2022-10

Locations

BR(1)