Multicenter Study of CAOMECS Transplantation to Patients With Total Limbal Stem Cell Deficiency

Status:

WITHDRAWN

Multicenter Study of CAOMECS Transplantation to Patients With Total Limbal Stem Cell Deficiency

Lead Sponsor:

CellSeed France S.A.R.L.

Collaborating Sponsors:

FGK Clinical Research GmbH

Conditions:

Limbal Stem Cell Deficiency

Eligibility:

All Genders

2-74 years

Phase:

PHASE3

Brief Summary

This clinical study is a scientific study on patients who do not have any limbal stem cells. In this clinical study tissue is taken from the inside of the mouth, and cells from that tissue (epithelial...

Detailed Description

This is an open clinical study without a control group, which means that all patients will be given the study treatment (CAOMECS). Adults as well as minor patients can participate in this clinical tr...

Eligibility Criteria

Inclusion

Age ≥2 years to 74 years
Males or females with bilateral or unilateral total LSCD due to one of the following causes:
Chemical burns
Thermal burns
Contact lens wear
Surgery of the ocular surface
Stevens-Johnson syndrome and other inflammatory disease under stable condition
Aniridia
Documented conjunctivalization of the corneal surface, measured by fluorescein staining
Stable disease, i.e. history of LSCD for at least 6 months
Clinical signs indicative of conjunctivalisation:
Superficial blood vessels on the corneal surface
Loss of epithelial transparency or persistent epithelial defect
Healthy oral mucosa
Absence from tobacco and alcohol (7 days before the biopsy)
Regular tooth brushing (at least twice daily)
Ability to comply with the protocol
Covered by a social security system
Signed informed consent form, ability to understand the study procedures, and contractual capability. Applicable to patient or legal carer (including parent)
Special inclusion criteria for patients between 18 and 74 years of age (adults):
Multiple surgeries in the limbal region

Exclusion

Acute systemic infection
Acute ocular inflammation in the previous 6 months
Previous neoplastic/cancer disease
Severe dry eye confirmed by a Schirmer test
Lyell-Syndrome, epidermolysis bullosa
Total symblepharon
Medical history of hypersensitivity or allergy to bovine or murine derived materials
Pregnant and lactating patients, positive urine pregnancy test in women of childbearing potential
Any systemic infectious disease as diagnosed by serology tests such as syphilis, HIV-1, HIV-2, hepatitis B or C, or HTLV-1 infection at screening and at the day of the biopsy
Current or previous (within 30 days of enrolment) treatment with another investigational drug or participation in another clinical study
Previous participation of the patient in this study
Evidence of any other medical conditions (such as psychiatric illness, physical examination or laboratory findings) that may interfere with the planned treatment, affect patient compliance or place the patient at high risk of treatment-related complications
Employees of the sponsor or patients who are employees or relatives of the investigator
Genetic conditions such as ectodermal dysplasia or multiple endocrine neoplasia
Special exclusion criteria for patients ≥2 and \<18 years of age (children):
Multiple surgeries in the limbal region

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01489501

Last Update

March 25 2015

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