Mensenchymal Stem Cell (MSC) Included in OrthADAPT Membrane for Rotator Cuff Tears Repair - Full Text View

Purpose

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.

Condition	Intervention	Phase
Chronic Disease	Biological: Mesenchymal Stem Cells (MSCs) Biological: OrthADAPT	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Treatment of Rotator Cuff Tears Using Autologous Bone Marrow Mensenchymal Stem Cell Transplantation.

Resource links provided by NLM:

MedlinePlus related topics: Coping with Chronic Illness

U.S. FDA Resources

Further study details as provided by Hospital San Carlos, Madrid:

Primary Outcome Measures:

Constant Shoulder Score [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Nuclear Magnetic Resonance (RMN) [ Time Frame: 6 months, one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
Study Start Date:	May 2010
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Mesenchymal stem cells (MSCs) Mesenchymal stem cells with a collagen type I membrane (OrthoADAPT)	Biological: Mesenchymal Stem Cells (MSCs) 20.000.000 autologous MSCs included in the OrthADAPT membrane. Single dosage.
Placebo Comparator: OrthADAPT Membrane of collagen type I (OrthoADAPT)	Biological: OrthADAPT

Detailed 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.

Eligibility

Ages Eligible for Study:	55 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687777

Contacts

Contact: Benjamín Fernández-Gutiérrez, PhD	+34913303615 ext 7803	bfernandez.hcsc@salud.madrid.org
Contact: Pilar Tornero-Esteban, PhD	+34913303615 ext 7434	mptornero@gmail.com

Locations

Spain
Hospital Universitario Clinico San Carlos	Recruiting
Madrid, Spain, 28040
Contact: Benjamin Fernandez-Gutierrez, MD, PhD +34913303615 ext 7803 bfernandez.hcsc@salud.madrid.org
Contact: Pilar Tornero-Esteban, Bs, PhD +34913303615 ext 7434 mptornero@gmail.com
Hospital Universitario Clinico San Carlos	Recruiting
Madrid, Spain, 28040
Contact: Benjamin Fernandez-Gutierrez, MD, PhD +34913303615 ext 7803 bfernandez.hcsc@salud.madrid.org
Contact: Pilar Tornero-Esteban, Bs,PhD +34913303615 ext 7434 mptornero@gmail.com

Sponsors and Collaborators

Hospital San Carlos, Madrid

Hospital General Universitario Gregorio Marañon

Investigators

Principal Investigator:	Benjamin Fernandez-Gutierrez, MD, PhD	Hospital Universitario Clinico San Carlos
Study Director:	Pilar Tornero-Esteban, Bs, PhD	Hospital Universitario Clinico San Carlos

More Information

Publications:

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Awad HA, Boivin GP, Dressler MR, Smith FN, Young RG, Butler DL. Repair of patellar tendon injuries using a cell-collagen composite. J Orthop Res. 2003 May;21(3):420-31.

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Pittenger MF, Mackay AM, Beck SC, Jaiswal RK, Douglas R, Mosca JD, Moorman MA, Simonetti DW, Craig S, Marshak DR. Multilineage potential of adult human mesenchymal stem cells. Science. 1999 Apr 2;284(5411):143-7.

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.

Saito T, Dennis JE, Lennon DP, Young RG, Caplan AI. Myogenic Expression of Mesenchymal Stem Cells within Myotubes of mdx Mice in Vitro and in Vivo. Tissue Eng. 1995 Winter;1(4):327-43.

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Smith RK, Korda M, Blunn GW, Goodship AE. Isolation and implantation of autologous equine mesenchymal stem cells from bone marrow into the superficial digital flexor tendon as a potential novel treatment. Equine Vet J. 2003 Jan;35(1):99-102.

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Responsible Party:	Benjamin Fernandez Gutierrez, Rheumatologist, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier:	NCT01687777 History of Changes
Other Study ID Numbers:	EC07/90208, 2007-007630-19
Study First Received:	September 11, 2012
Last Updated:	September 18, 2012
Health Authority:	Spain: Ethics Committee Spain: Spanish Agency of Medicines Spain: Ministry of Health and Consumption

Keywords provided by Hospital San Carlos, Madrid:

Supraspinatus tendon
Mesenchymal stem cells
OrthADAPT
Rotator cuff

Additional relevant MeSH terms:

Chronic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013

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