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

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ClinicalTrials.gov Identifier: NCT00845117
Recruitment Status : Unknown
Verified June 2013 by Ethisch Comité UZ Antwerpen, University Hospital, Antwerp.
Recruitment status was:  Active, not recruiting
First Posted : February 18, 2009
Last Update Posted : June 20, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Limbal Stem Cell Deficiency Procedure: Cultivated limbal stem cell graft transplantation Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency
Study Start Date : July 2008
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Visual Acuity [ Time Frame: Just before surgery and upto 1 years after surgery ]
  2. Conjunctivalization [ Time Frame: Just before surgery and upto 1 years after surgery ]
  3. Vascularization [ Time Frame: Just before surgery and upto 1 years after surgery ]
  4. Epithelialization [ Time Frame: Just before surgery and upto 1 years after surgery ]

Secondary Outcome Measures :
  1. Prolonged subsequent corneal graft survival time [ Time Frame: 1 year post corneal transplant ]

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: February 18, 2009    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: June 2013

Keywords provided by Ethisch Comité UZ Antwerpen, University Hospital, Antwerp:
Aniridia,
Steven Johnsons Syndrome,
Ocular burns,
Pterygium