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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

February 17, 2009
June 19, 2013
July 2008
June 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00845117 on ClinicalTrials.gov Archive Site
Prolonged subsequent corneal graft survival time [ Time Frame: 1 year post corneal transplant ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency
Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Limbal Stem Cell Deficiency
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.
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.
Intervention: Procedure: Cultivated limbal stem cell graft transplantation
Zakaria N, Koppen C, Van Tendeloo V, Berneman Z, Hopkinson A, Tassignon MJ. Standardized limbal epithelial stem cell graft generation and transplantation. Tissue Eng Part C Methods. 2010 Oct;16(5):921-7. doi: 10.1089/ten.TEC.2009.0634.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
21
June 2014
June 2014   (final data collection date for primary outcome measure)

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)
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00845117
EC 7/28/153
Not Provided
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
Ethisch Comité UZ Antwerpen
  • Fund for Scientific Research, Flanders, Belgium
  • European Society of Cataract and Refractive Surgeons
  • Agentschap voor Innovatie door Wetenschap en Technologie
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
University Hospital, Antwerp
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP