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OpenTrials
Completed

NCT Number: NCT01562002

Safety Study of Stem Cell Transplant to Treat Limbus Insufficiency Syndrome

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

IOBA

Valladolid, 47011, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stem Cell with Amniotic Membrane Transplant

Procedure

Single stem cell expansion in amniotic membrane transplant

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. Improvement of 2 lines in Best Corrected Visual Acuity

    Time frame: 12 month

    Improvement in visual acuity compared to baseline values before transplant

Sponsors and collaborators

Lead sponsor

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

Other

Collaborators

  • Centro en Red de Medicina Regenerativa de Castilla y Leon
  • Red de Terapia Celular
  • University of Valladolid

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 23, 2012
Registry last updated
Jan 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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