Study Stopped
Preliminar results not favorable
ABCB5 as a Prognostic Marker in Survival of Cultivated Limbal Stem Cell Transplantation
1 other identifier
interventional
10
1 country
1
Brief Summary
In this study the prognostic value of ABCB5 in survival of the limbal stem cell transplantation expanded in vitro on amniotic membrane for corneal surface reconstruction in patients with limbal stem cell deficiency will be analyzed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 11, 2015
CompletedFirst Posted
Study publicly available on registry
October 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedMarch 6, 2018
March 1, 2018
3 years
October 11, 2015
March 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Objective clinical evaluation
A grading system from 0 to 4 using photographs taken with slit lamp, will be used to determine by two independent examiners the degree of corneal transparency and superficial vascularization.
6 months
Objective clinical evaluation
A grading system from 0 to 4 using photographs taken with slit lamp, will be used to determine by two independent examiners the degree of corneal transparency and superficial vascularization.
12 months
Secondary Outcomes (6)
Corneal cells morphology
6 months
Corneal cells morphology
12 months
Quality of life questionnaire
6 months
Quality of life questionnaire
12 months
Visual acuity
6 months
- +1 more secondary outcomes
Study Arms (1)
Stem Cell Transplantation
EXPERIMENTALCultivated Limbal Stem Cell Transplantation
Interventions
A complete conjunctival peritomy is performed and the fibrovascular pannus and conjunctiva invading the cornea is dissected from the cornea and limbus.
The amniotic membrane graft cultured with the human limbal stem cell transplantation is placed in the limbic and corneal surface and fixed with fibrin glue. The amniotic membrane is placed with the stroma in contact with the graft and it is sutured.
Eligibility Criteria
You may qualify if:
- Bilateral limbal stem cell deficiency of any etiology.
- Corneal impression cytology positive for goblet cells.
- Ocular ultrasound results within normal parameters.
- Agree to participate in the study and sign the informed consent.
You may not qualify if:
- \. Active immunological diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de Oftalmologia Conde de Valenciana
Mexico City, 06800, Mexico
Related Publications (1)
Serna-Ojeda JC, Garcia-Mejia M, Graue-Hernandez EO, Navas A, Garfias Y. Short-Term Results Analysis in the Allogenic Transplantation of Limbal Stem Cells Expanded on Amniotic Membrane in Patients with Bilateral Limbal Stem Cell Deficiency. J Ocul Pharmacol Ther. 2020 May;36(4):238-246. doi: 10.1089/jop.2019.0147. Epub 2020 Feb 20.
PMID: 32077779DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yonathan Garfias, MD, PhD
Instituto de Oftalmologia Conde de Valenciana
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2015
First Posted
October 20, 2015
Study Start
March 1, 2015
Primary Completion
March 1, 2018
Study Completion
March 1, 2018
Last Updated
March 6, 2018
Record last verified: 2018-03