Suspended

msctendonrepTreatment of Rotator Cuff Tears Using Autologous Bone Marrow Mensenchymal Stem Cell Transplantation.

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What is being tested

Mesenchymal Stem Cells (MSCs)

+ OrthADAPT

Biological
Who is being recruted

Pathologic Processes+1

+ Pathological Conditions, Signs and Symptoms

+ Disease Attributes

From 55 to 80 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: May 2010
See protocol details

Summary

Principal SponsorHospital San Carlos, Madrid
Study ContactBenjamín Fernández-Gutiérrez, PhDMore contacts
Last updated: September 19, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2010

Actual date on which the first participant was enrolled.

The investigators will include: Patients with massive tears from the supraspinatus tendon, in which reconstructive surgery is indicated. Patients will be randomly stratified into two groups. The first group will receive autologous MSCs transplantation included in a collagen type I membrane (OrthADAPT) and the second group will serve as cell-free controls. The surgical procedure will be performed by arthroscopic and/or combined technique: arthroscopic subacromial decompression and mini-open rotator cuff repair. The OrthADAPT-cells composite will be put on the sutured area. The radiograms and function will be assessed by independently observers, who will no have knowledge of the study group from which they will have been obtained.

NCT01687777
Principal SponsorHospital San Carlos, Madrid
Study ContactBenjamín Fernández-Gutiérrez, PhDMore contacts
Last updated: September 19, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 55 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Pathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesChronic Disease

Criteria

7 inclusion criteria required to participate
Comprised subject male/female aged 55-80
Rupture is enough to need medical assistance
Subject has a "reparable" injury according to Goutallier s criteria
Subject has a supraspinatus tendon rupture
Show More Criteria
1 exclusion criteria prevent from participating
Subject has a prior clinical history of arthritis, diabetes or inflammatory disease

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Mesenchymal stem cells with a collagen type I membrane (OrthoADAPT)

Group II

Placebo
Membrane of collagen type I (OrthoADAPT)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Hospital Universitario Clinico San Carlos

Madrid, SpainOpen Hospital Universitario Clinico San Carlos in Google Maps
Recruiting

Hospital Universitario Clinico San Carlos

Madrid, Spain
Suspended2 Study Centers