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Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency (LECT)

This study is currently recruiting participants.
Verified February 2009 by University Hospital, Antwerp
Sponsor:
Collaborators:
Fund for Scientific Research, Flanders, Belgium
European Society of Cataract and Refractive Surgeons
Agentschap voor Innovatie door Wetenschap en Technologie
Information provided by:
University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT00845117
First received: February 17, 2009
Last updated: July 12, 2010
Last verified: February 2009
History of Changes
  Purpose

The purpose of this study is to determine whether cultivated stem cell transplantation is effective for the treatment of patients wtih corneal stem cell deficiency.


Condition Intervention Phase
Limbal Stem Cell Deficiency
 Procedure: Cultivated limbal stem cell graft transplantation
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • Visual Acuity [ Time Frame: Just before surgery and upto 1 years after surgery ] [ Designated as safety issue: Yes ]
  • Conjunctivalization [ Time Frame: Just before surgery and upto 1 years after surgery ] [ Designated as safety issue: Yes ]
  • Vascularization [ Time Frame: Just before surgery and upto 1 years after surgery ] [ Designated as safety issue: Yes ]
  • Epithelialization [ Time Frame: Just before surgery and upto 1 years after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Prolonged subsequent corneal graft survival time [ Time Frame: 1 year post corneal transplant ] [ Designated as safety issue: No ]

Estimated Enrollment: 9
Study Start Date: July 2008
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Limbal Stem Cell Transplant
The cornea is debrided of all superficial fibrovascular tissue and the cultivated stem cell graft is glued onto the cornea.
 Procedure: Cultivated limbal stem cell graft transplantation
A limbal biopsy taken from the contralateral good eye in cases of unilateral disease or from a living related or cadaveric donor in cases of bilateral disease. The limbal stem cells from the biopsy are cultivated until a sheet of cells measuring approximately 12mm in diameter is obtained. This is then ready for transplantation onto the diseased eye.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients suffering from LSCD IIa and IIb. Those suffering from IIc may be included once inflammation has subsided and cornea can be staged as IIb.
  • Age: ≥ 18 years
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
  • Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation

Exclusion Criteria:

  • Subjects who are pregnant or lactating
  • Subjects who have sensitivity to drugs that provide local anesthesia
  • Subjects suffering from active infection of the external eye
  • Medical conditions that prohibit the use of systemic immunosuppression (in cases of allogenic transplantation)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845117

Contacts
Contact: Nadia Zakaria, MBBS +32 3 821 4066 Nadia.Zakaria@uza.be

Locations
Belgium
University Hospital Antwerp Recruiting
Antwerp, Edegem, Belgium, 2650
Contact: Nadia Zakaria, MD     +32 3 821 4066     Nadia.Zakaria@uza.be    
Principal Investigator: Nadia Zakaria, MD            
Sub-Investigator: Carina Koppen, MD            
Sponsors and Collaborators
University Hospital, Antwerp
Fund for Scientific Research, Flanders, Belgium
European Society of Cataract and Refractive Surgeons
Agentschap voor Innovatie door Wetenschap en Technologie
Investigators
Principal Investigator: Nadia Zakaria, MBBS University Hospital, Antwerp
Principal Investigator: Viggo V Tendeloo, PhD University Hospital, Antwerp
Principal Investigator: Carina Koppen, MD University Hospital, Antwerp
Study Director: Marie J Tassignon, MD, PhD University Hospital, Antwerp
Study Chair: Zwi Berneman, MD,PhD University Hospital, Antwerp
  More Information

No publications provided

Responsible Party: Tassignon, Marie Jose / Professor head of the department of Ophthalmology, University Hospital Antwerp
ClinicalTrials.gov Identifier: NCT00845117     History of Changes
Other Study ID Numbers: EC 7/28/153
Study First Received: February 17, 2009
Last Updated: July 12, 2010
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Antwerp:
Aniridia,
Steven Johnsons Syndrome,
Ocular burns,
Pterygium

ClinicalTrials.gov processed this record on May 16, 2013