NCT01687777

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2010

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

September 19, 2012

Status Verified

September 1, 2012

Enrollment Period

3.1 years

First QC Date

September 11, 2012

Last Update Submit

September 18, 2012

Conditions

Chronic Disease

Keywords

Supraspinatus tendonMesenchymal stem cellsOrthADAPTRotator cuff

Outcome Measures

Primary Outcomes (1)

  • Constant Shoulder Score

    up to 1 year

Secondary Outcomes (1)

  • Nuclear Magnetic Resonance (RMN)

    6 months, one year

Study Arms (2)

Mesenchymal stem cells (MSCs)

ACTIVE COMPARATOR

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

Biological: Mesenchymal Stem Cells (MSCs)

OrthADAPT

PLACEBO COMPARATOR

Membrane of collagen type I (OrthoADAPT)

Biological: OrthADAPT

Interventions

Mesenchymal Stem Cells (MSCs)BIOLOGICAL

20.000.000 autologous MSCs included in the OrthADAPT membrane. Single dosage.

Mesenchymal stem cells (MSCs)
OrthADAPTBIOLOGICAL
OrthADAPT

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitario Clinico San Carlos

Madrid, Madrid, 28040, Spain

RECRUITING

Hospital Universitario Clinico San Carlos

Madrid, Madrid, 28040, Spain

RECRUITING

Related Publications (26)

  • Awad HA, Butler DL, Boivin GP, Smith FN, Malaviya P, Huibregtse B, Caplan AI. Autologous mesenchymal stem cell-mediated repair of tendon. Tissue Eng. 1999 Jun;5(3):267-77. doi: 10.1089/ten.1999.5.267.

    PMID: 10434073BACKGROUND

  • 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.

    PMID: 12706014BACKGROUND

  • Barber FA, Aziz-Jacobo J. Biomechanical testing of commercially available soft-tissue augmentation materials. Arthroscopy. 2009 Nov;25(11):1233-9. doi: 10.1016/j.arthro.2009.05.012. Epub 2009 Oct 2.

    PMID: 19896044BACKGROUND

  • 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.

    PMID: 9027588BACKGROUND

  • 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.

    PMID: 9698003BACKGROUND

  • Caplan AI. Mesenchymal stem cells. J Orthop Res. 1991 Sep;9(5):641-50. doi: 10.1002/jor.1100090504.

    PMID: 1870029BACKGROUND

  • Caplan AI. The mesengenic process. Clin Plast Surg. 1994 Jul;21(3):429-35.

    PMID: 7924141BACKGROUND

  • Caplan AI. Review: mesenchymal stem cells: cell-based reconstructive therapy in orthopedics. Tissue Eng. 2005 Jul-Aug;11(7-8):1198-211. doi: 10.1089/ten.2005.11.1198.

    PMID: 16144456BACKGROUND

  • 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.

    PMID: 11205861BACKGROUND

  • Djurasovic M, Marra G, Arroyo JS, Pollock RG, Flatow EL, Bigliani LU. Revision rotator cuff repair: factors influencing results. J Bone Joint Surg Am. 2001 Dec;83(12):1849-55. doi: 10.2106/00004623-200112000-00013.

    PMID: 11741065BACKGROUND

  • 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.

    PMID: 14960664BACKGROUND

  • 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. doi: 10.1016/j.jbiomech.2006.02.010. Epub 2006 Apr 4.

    PMID: 16600252BACKGROUND

  • 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.

    PMID: 14671517BACKGROUND

  • 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.

    PMID: 1874784BACKGROUND

  • Jaiswal N, Haynesworth SE, Caplan AI, Bruder SP. Osteogenic differentiation of purified, culture-expanded human mesenchymal stem cells in vitro. J Cell Biochem. 1997 Feb;64(2):295-312.

    PMID: 9027589BACKGROUND

  • 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.

    PMID: 17415772BACKGROUND

  • Jost B, Pfirrmann CW, Gerber C, Switzerland Z. Clinical outcome after structural failure of rotator cuff repairs. J Bone Joint Surg Am. 2000 Mar;82(3):304-14. doi: 10.2106/00004623-200003000-00002.

    PMID: 10724223BACKGROUND

  • 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.

    PMID: 15808623BACKGROUND

  • Pillow RP, Epstein RB, Buckner CD, Giblett ER, Thomas ED. Treatment of bone-marrow failure by isogeneic marrow infusion. N Engl J Med. 1966 Jul 14;275(2):94-7. doi: 10.1056/NEJM196607142750209. No abstract available.

    PMID: 5327813BACKGROUND

  • 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.

    PMID: 10102814BACKGROUND

  • 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.

    PMID: 12784007BACKGROUND

  • 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.

    PMID: 19877897BACKGROUND

  • 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.

    PMID: 10546622BACKGROUND

  • 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.

    PMID: 12553472BACKGROUND

  • Wakitani S, Goto T, Pineda SJ, Young RG, Mansour JM, Caplan AI, Goldberg VM. Mesenchymal cell-based repair of large, full-thickness defects of articular cartilage. J Bone Joint Surg Am. 1994 Apr;76(4):579-92. doi: 10.2106/00004623-199404000-00013.

    PMID: 8150826BACKGROUND

  • 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.

    PMID: 12690842BACKGROUND

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Benjamin Fernandez-Gutierrez, MD, PhD

    Hospital Universitario Clinico San Carlos

    PRINCIPAL INVESTIGATOR

  • Pilar Tornero-Esteban, Bs, PhD

    Hospital Universitario Clinico San Carlos

    STUDY DIRECTOR

Central Study Contacts

Benjamín Fernández-Gutiérrez, PhD

CONTACT

+34913303615bfernandez.hcsc@salud.madrid.org

Pilar Tornero-Esteban, PhD

CONTACT

+34913303615mptornero@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Rheumatologist

Study Record Dates

First Submitted

September 11, 2012

First Posted

September 19, 2012

Study Start

May 1, 2010

Primary Completion

June 1, 2013

Study Completion

December 1, 2013

Last Updated

September 19, 2012

Record last verified: 2012-09

Locations

ES(2)