Cell Therapy in Failure Syndromes in Limbal Stem Cells (TC181)
|ClinicalTrials.gov Identifier: NCT01619189|
Recruitment Status : Unknown
Verified February 2015 by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts.
Recruitment status was: Active, not recruiting
First Posted : June 14, 2012
Last Update Posted : February 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Limbal Deficiency||Biological: epithelial stem cells cultured Procedure: transplantation of cultured cells||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Thérapie Cellulaire au Cours Des Syndromes d'Insuffisance en Cellules Souches Limbiques|
|Study Start Date :||June 2007|
|Primary Completion Date :||December 2014|
Biological: epithelial stem cells cultured
- survival of the transplanted epithelium [ Time Frame: 3 years ]survival of the transplanted epithelium defined by absence of recurrence of the clinical signs of limbal deficiency (opacification of the corneal epithelium, irregularity of the corneal epithelium, surface corneal vascularization) in the central cornea.
- visual acuity [ Time Frame: 3 years ]
- re-epithelialization time after keratoplasty [ Time Frame: 3 years ]The healing time of corneal epithelium will be collectively assed by investigators form the CRF and the pictures taken during the study.
- Symptoms [ Time Frame: 3 years ]
Symptoms recorded at each visit:
- redness : absent (0) - present (1)
- pain : absent (0) - present (1)
- burning : absent (0) - present (1)
- foreign body sensation : absent (0) - present (1)
- photophobia : absent (0) - present (1)
- blurred vision : absent (0) - present (1)
Grading of symptoms : sum of all symptoms (0-6)
- morphometric analysis of the ocular surface [ Time Frame: 3 years ]the morphometric analysis of the corneal epithelial ulcerations will be assed by the CRA from the pictures of the corneal surface.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619189
|CHNO des quinze-vingts|
|Paris, France, 75012|