Mensenchymal Stem Cell (MSC) Included in OrthADAPT Membrane for Rotator Cuff Tears Repair

Chronic Disease Clinical Trial

— msctendonrep  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01687777
• Other study ID #: EC07/90208
• Secondary ID: 2007-007630-19
• Status: Recruiting
• Phase: Phase 2
• First received: September 11, 2012
• Last updated: September 18, 2012
• Start date: May 2010
• Est. completion date: December 2013

Study information

• Verified date: September 2012
• Source: Hospital San Carlos, Madrid
• Contact: Benjamín Fernández-Gutiérrez, PhD
• Phone: +34913303615
• Email: bfernandez.hcsc[@]salud.madrid.org
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeSpain: Spanish Agency of MedicinesSpain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial Summary

Surgical reconstructive procedures for rotator cuff tears present a number of limitations. The few studies in which the repair integrity is evaluated, have shown the existence of a high rate of reruptures in spite of the fact that the functional results obtained short-term are satisfactory. Morphologic analysis from the sutures, after different follow-up periods, has not shown satisfactory results.

Thus, the purpose of the current study was to test the hypotheses that mesenchymal stem cells (MSCs) included in a membrane into rotator cuff tears improves, the radiograms and the function compared to cell-free tendon defect treatment.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subject providing informed consent.

• Comprised subject male/female aged 55-80.

• Subject has a supraspinatus tendon rupture.

• Subject has an unilateral injury.

• Rupture is enough to need medical assistance.

• Subject has an conventional medical treatment fail at least 3 months.

• Subject has a "reparable" injury according to Goutallier´s criteria.

Exclusion Criteria:

• Subject has a prior clinical history of arthritis, diabetes or inflammatory disease.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease

Intervention

Biological:
• Mesenchymal Stem Cells (MSCs)
20.000.000 autologous MSCs included in the OrthADAPT membrane. Single dosage.
• OrthADAPT

Locations

Country	Name	City	State
Spain	Hospital Universitario Clinico San Carlos	Madrid
Spain	Hospital Universitario Clinico San Carlos	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid	Hospital General Universitario Gregorio Marañon

Country where clinical trial is conducted

Spain, 

References & Publications (26)

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Gimbel JA, Van Kleunen JP, Lake SP, Williams GR, Soslowsky LJ. The role of repair tension on tendon to bone healing in an animal model of chronic rotator cuff tears. J Biomech. 2007;40(3):561-8. Epub 2006 Apr 4. — View Citation

Goutallier D, Postel JM, Gleyze P, Leguilloux P, Van Driessche S. Influence of cuff muscle fatty degeneration on anatomic and functional outcomes after simple suture of full-thickness tears. J Shoulder Elbow Surg. 2003 Nov-Dec;12(6):550-4. — View Citation

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Prickett WD, Teefey SA, Galatz LM, Calfee RP, Middleton WD, Yamaguchi K. Accuracy of ultrasound imaging of the rotator cuff in shoulders that are painful postoperatively. J Bone Joint Surg Am. 2003 Jun;85-A(6):1084-9. — View Citation

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Yamaguchi K, Levine WN, Marra G, Galatz LM, Klepps S, Flatow EL. Transitioning to arthroscopic rotator cuff repair: the pros and cons. Instr Course Lect. 2003;52:81-92. Review. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Constant Shoulder Score		up to 1 year	No
Secondary	Nuclear Magnetic Resonance (RMN)		6 months, one year	Yes