Safety Study of Stem Cell Transplant to Treat Limbus Insufficiency Syndrome (NCT01562002) | Clinical Trial Compass
CompletedPhase 1/2
Safety Study of Stem Cell Transplant to Treat Limbus Insufficiency Syndrome
Spain27 participantsStarted 2012-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 wit…
What they're measuring
1
Viability and safety of mesenchymal stem cell transplant
Timeframe: 1 Year
Trial details
NCT IDNCT01562002
SponsorInstituto Universitario de OftalmobiologĂa Aplicada (Institute of Applied Ophthalmobiology) - IOBA