Mensenchymal Stem Cell (MSC) Included in OrthADAPT Membrane for Rotator Cuff Tears Repair
NCT ID: NCT01687777
Last Updated: 2012-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
10 participants
INTERVENTIONAL
2010-05-31
2013-12-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Mesenchymal stem cells (MSCs)
Mesenchymal stem cells with a collagen type I membrane (OrthoADAPT)
Mesenchymal Stem Cells (MSCs)
20.000.000 autologous MSCs included in the OrthADAPT membrane. Single dosage.
OrthADAPT
Membrane of collagen type I (OrthoADAPT)
OrthADAPT
Interventions
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Mesenchymal Stem Cells (MSCs)
20.000.000 autologous MSCs included in the OrthADAPT membrane. Single dosage.
OrthADAPT
Eligibility Criteria
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Inclusion Criteria
* 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
55 Years
80 Years
ALL
No
Sponsors
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Hospital General Universitario Gregorio Marañon
OTHER
Hospital San Carlos, Madrid
OTHER
Responsible Party
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Benjamin Fernandez Gutierrez
Rheumatologist
Principal Investigators
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Benjamin Fernandez-Gutierrez, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Clinico San Carlos
Pilar Tornero-Esteban, Bs, PhD
Role: STUDY_DIRECTOR
Hospital Universitario Clinico San Carlos
Locations
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Hospital Universitario Clinico San Carlos
Madrid, Madrid, Spain
Hospital Universitario Clinico San Carlos
Madrid, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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Benjamin Fernandez-Gutierrez, MD, PhD
Role: primary
Pilar Tornero-Esteban, Bs, PhD
Role: backup
Benjamin Fernandez-Gutierrez, MD, PhD
Role: primary
Pilar Tornero-Esteban, Bs,PhD
Role: backup
References
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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. doi: 10.1016/S0736-0266(02)00163-8.
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Bruder SP, Jaiswal N, Haynesworth SE. Growth kinetics, self-renewal, and the osteogenic potential of purified human mesenchymal stem cells during extensive subcultivation and following cryopreservation. J Cell Biochem. 1997 Feb;64(2):278-94. doi: 10.1002/(sici)1097-4644(199702)64:23.0.co;2-f.
Bruder SP, Kraus KH, Goldberg VM, Kadiyala S. The effect of implants loaded with autologous mesenchymal stem cells on the healing of canine segmental bone defects. J Bone Joint Surg Am. 1998 Jul;80(7):985-96. doi: 10.2106/00004623-199807000-00007.
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Cofield RH, Parvizi J, Hoffmeyer PJ, Lanzer WL, Ilstrup DM, Rowland CM. Surgical repair of chronic rotator cuff tears. A prospective long-term study. J Bone Joint Surg Am. 2001 Jan;83(1):71-7. doi: 10.2106/00004623-200101000-00010.
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Galatz LM, Ball CM, Teefey SA, Middleton WD, Yamaguchi K. The outcome and repair integrity of completely arthroscopically repaired large and massive rotator cuff tears. J Bone Joint Surg Am. 2004 Feb;86(2):219-24. doi: 10.2106/00004623-200402000-00002.
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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. doi: 10.1016/s1058-2746(03)00211-8.
Harryman DT 2nd, Mack LA, Wang KY, Jackins SE, Richardson ML, Matsen FA 3rd. Repairs of the rotator cuff. Correlation of functional results with integrity of the cuff. J Bone Joint Surg Am. 1991 Aug;73(7):982-9.
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Johnson W, Inamasu J, Yantzer B, Papangelou C, Guiot B. Comparative in vitro biomechanical evaluation of two soft tissue defect products. J Biomed Mater Res B Appl Biomater. 2007 Apr 5. doi: 10.1002/jbm.b.30816. Online ahead of print.
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Mansilla E, Marin GH, Sturla F, Drago HE, Gil MA, Salas E, Gardiner MC, Piccinelli G, Bossi S, Salas E, Petrelli L, Iorio G, Ramos CA, Soratti C. Human mesenchymal stem cells are tolerized by mice and improve skin and spinal cord injuries. Transplant Proc. 2005 Jan-Feb;37(1):292-4. doi: 10.1016/j.transproceed.2005.01.070.
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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. doi: 10.1126/science.284.5411.143.
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(6):1084-9. doi: 10.2106/00004623-200306000-00016.
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. doi: 10.1089/ten.1995.1.327.
Romeo AA, Hang DW, Bach BR Jr, Shott S. Repair of full thickness rotator cuff tears. Gender, age, and other factors affecting outcome. Clin Orthop Relat Res. 1999 Oct;(367):243-55.
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. doi: 10.2746/042516403775467388. No abstract available.
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Other Identifiers
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2007-007630-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EC07/90208
Identifier Type: -
Identifier Source: org_study_id