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

NCT01489501 | Withdrawn Phase 3

• 2 other identifiers: CS001-EU012011-000598-30
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 cells) will be grown to form a multilayered cell-sheet, called CAOMECS, which is then transplanted onto the cornea. This transplantation method should repair the damage of the cornea. The aim of this study is to see if the transplantation of CAOMECS renews the surface of the eye, by preventing the growth of the conjunctiva over the cornea and stopping new small blood vessels forming.

Conditions

Limbal Stem Cell Deficiency

Keywords

Caomecs, Transplantation, Limbal stem cell deficiency,

Outcome Measures

Primary Outcomes (2)

• Presence of a stable epithelium on cornea and absence of conjunctivalization in the visual axis

  This is assessed by delayed fluorescein staining and impression cytology.

  month 12

• Extent of neovascularization

  Measurement of the area of corneal neovascularisation as documented by photographs.

  month 12

Secondary Outcomes (2)

• Presence of a stable epithelium on cornea and absence of conjunctivalization in the visual axis

  month 24 and 36

• Extent of neovascularization

  month 24 and 36

Study Arms (1)

only one arm available

EXPERIMENTAL

Caomecs transplantation on eye cornea.

Procedure: Surgical transplantation of CAOMECS to the ocular surface

Interventions

Surgical transplantation of CAOMECS to the ocular surface PROCEDURE

Surgical transplantation of oral mucosa derived CAOMECS sheet onto eye cornea.

only one arm available

Eligibility Criteria

• Age: 2 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Multiple surgeries in the limbal region

Sponsors & Collaborators

• CellSeed France S.A.R.L.: lead
• FGK Clinical Research GmbH: collaborator

Study Sites (1)

Universitätsklinkum Erlangen

Erlangen, Bavaria, 91054, Germany

Location

MeSH Terms

Conditions

Limbal Stem Cell Deficiency

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Friedrich Kruse, Prof. Dr.

  Medizinische Fakultät der Friedrich-Alexander-Universität Erlangen-Nürnberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: December 9, 2011
• Last Updated: March 25, 2015

Record last verified: 2015-03

Locations

DE (1)