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Trial record 1 of 1 for:    NCT01562002
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Safety Study of Stem Cell Transplant to Treat Limbus Insufficiency Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01562002
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : January 8, 2015
Sponsor:
Collaborators:
University of Valladolid
Centro en Red de Medicina Regenerativa de Castilla y Leon
Red de Terapia Celular
Information provided by (Responsible Party):
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

Tracking Information
First Submitted Date  ICMJE March 22, 2012
First Posted Date  ICMJE March 23, 2012
Last Update Posted Date January 8, 2015
Study Start Date  ICMJE March 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2012)
Viability and safety of mesenchymal stem cell transplant [ Time Frame: 1 Year ]
Absence of cell metaplasia with phenotype different to corneal or conjunctival as expected, confirmed by corneal impression cytology and in vivo confocal laser ophthalmoscopy
Original Primary Outcome Measures  ICMJE
 (submitted: March 22, 2012)
Viability and safety of mesenchymal stem cell transplant [ Time Frame: 1 Year ]
Absence of cell metaplasia with phenotype different to corneal or conjunctival as expected, confirmed by corneal impression cytology and in vivo confocal laser opthalmoscopy
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2012)
  • Absence of complications in pre and peri surgical implantation [ Time Frame: 1 Week ]
    Correct handling and implantation of stem cell with amniotic membrane transplant following an 4 step classification.
  • Improvement of 2 lines in Best Corrected Visual Acuity [ Time Frame: 12 month ]
    Improvement in visual acuity compared to baseline values before transplant
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Stem Cell Transplant to Treat Limbus Insufficiency Syndrome
Official Title  ICMJE Advanced Therapy for Ocular Surface Reconstruction. Allogenic Limbus Epithelial Stem-cell Transplant vs Bone Marrow Mesenchymal Stem-cell Transplant in Limbus Insufficiency Syndrome. Double-masked Randomized Trial
Brief Summary The purpose of the study is to determine whether allogenic bone marrow stem cell transplant is safe and effective in the treatment of limbus insufficiency syndrome versus allogenic limbus stem cell transplant.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Limbus Corneae Insufficiency Syndrome
Intervention  ICMJE Procedure: Stem Cell with Amniotic Membrane Transplant
Single stem cell expansion in amniotic membrane transplant
Study Arms  ICMJE
  • Experimental: Bone Marrow mesenchymal stem cell
    Allogenic Bone Marrow mesenchymal stem cell in amniotic membrane transplant
    Intervention: Procedure: Stem Cell with Amniotic Membrane Transplant
  • Active Comparator: Allogenic limbal stem cell Transplant
    Stem Cell with Amniotic Membrane Transplant
    Intervention: Procedure: Stem Cell with Amniotic Membrane Transplant
Publications * Calonge M, Pérez I, Galindo S, Nieto-Miguel T, López-Paniagua M, Fernández I, Alberca M, García-Sancho J, Sánchez A, Herreras JM. A proof-of-concept clinical trial using mesenchymal stem cells for the treatment of corneal epithelial stem cell deficiency. Transl Res. 2019 Apr;206:18-40. doi: 10.1016/j.trsl.2018.11.003. Epub 2018 Nov 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 7, 2015)
27
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2012)
30
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or Female older than 18 years.
  • Signed Informed consent
  • Negative pregnancy test at inclusion for any potential childbearing female.
  • Compromise of contraceptive method during all trial for any potential childbearing female.
  • Diagnosis of Ocular Surface Failure due to Limbus Insufficiency Syndrome, based in any of the published characteristics as corneal surface neovascularization, loss of corneal transparency, epithelial irregularities, history of punctate keratitis, erosions or repetitive ulcers and presence of symptoms and confirmed by the presence of epithelial phenotype cells assessed with conjunctival impression cytology.
  • Availability for all the scheduled visits during the study

Exclusion Criteria:

  • Uncontrolled systemic disease (e.g. hypertension or diabetes) or any disease that under medical decision might put the patient at risk during the surgery or follow-up examinations or may cause any hazard in data analysis.
  • Active ocular infection in any eye. If the infection can be cured, inclusion can be considered after 30 days of inactive infection since its end.
  • Alterations in lid statics / dynamics or any other pathology (e.g. severe dry eye syndrome) except the one that originated the Limbus Insufficience that under medical opinion might alter the results. Any of these must be corrected 3 months prior to patient inclusion, before reconsidering rescreening.
  • Limbus insufficiency syndrome which has not been previously treated with all medical (not surgical) procedures available.
  • No availability for all scheduled visits during the study.
  • Any other circumstance under investigator´s opinion that prevents patient inclusion even though normal inclusion and exclusion criteria are met.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01562002
Other Study ID Numbers  ICMJE IOBA-05-2010
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University of Valladolid
  • Centro en Red de Medicina Regenerativa de Castilla y Leon
  • Red de Terapia Celular
Investigators  ICMJE
Principal Investigator: Margarita Calonge, MD, PhD Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
PRS Account Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP