Autologous Cultured Corneal Epithelium (CECA) for the Treatment of Limbal Stem Cell Deficiency

  • STATUS
    Recruiting
  • End date
    Dec 9, 2027
  • participants needed
    54
  • sponsor
    CHU de Quebec-Universite Laval
Updated on 12 September 2021

Summary

The study " Autologous cultured corneal epithelium (CECA) for the treatment of corneal lesions associated with limbal stem cell deficiency" is the first clinical trial of this product manufactured at the LOEX laboratory. The culture of corneal epithelium strives to produce a reconstructed tissue with the therapeutical aim of treatment of limbal stem cell deficiency. The study is a phase I/phase II study with the goal to evaluate safety and efficacy of the CECA graft for the treatment of human patients suffering from limbal stem cell deficiency.

The trial is open to all genders. The inclusion of 5 minors is planned.

Details
Condition Limbal Stem Cell Deficiency
Treatment surgical transplantation of CECA
Clinical Study IdentifierNCT01756365
SponsorCHU de Quebec-Universite Laval
Last Modified on12 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

All genders
Adults
Minors
LSCD in one or two eyes. A minimum of 1-3 mm2 of undamaged limbus is required for a biopsy to be taken without foreseeable adverse consequences for the donor eye

Exclusion Criteria

Donor eye not sufficiently healthy to allow for the harvesting of a 1-3 mm2 limbal biopsy without foreseeable consequences for the donor eye
Pregnancy
Breast-feeding
Incapacitated person
known allergy to aprotinine (Trasylol (R))
Hypersensibility to bovine proteins
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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