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

This study is ongoing, but not recruiting participants.
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 (Responsible Party):
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT00845117
First received: February 17, 2009
Last updated: June 19, 2013
Last verified: June 2013
  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:


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 ]

Enrollment: 21
Study Start Date: July 2008
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (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

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.
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00845117

Locations
Belgium
University Hospital Antwerp
Antwerp, Edegem, Belgium, 2650
Sponsors and Collaborators
Ethisch Comité UZ Antwerpen
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, PhD University Hospital, Antwerp
Principal Investigator: Carina Koppen, MD, PhD University Hospital, Antwerp
Study Director: Marie J Tassignon, MD, PhD University Hospital, Antwerp
Study Chair: Zwi Berneman, MD,PhD University Hospital, Antwerp
  More Information

Publications:
Responsible Party: Ethisch Comité UZ Antwerpen, Prof. Dr. Marie-Jose Tassignon, 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: June 19, 2013
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 July 31, 2014