Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency

Limbal Stem Cell Deficiency Clinical Trial

— LECT  

Official title:

Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00845117
• Other study ID #: EC 7/28/153
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: February 17, 2009
• Last updated: June 19, 2013
• Start date: July 2008
• Est. completion date: June 2014

Study information

• Verified date: June 2013
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Limbal Stem Cell Deficiency

Intervention

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.

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Antwerp	Edegem

Sponsors (4)

Lead Sponsor	Collaborator
Ethisch Comité UZ Antwerpen	Agentschap voor Innovatie door Wetenschap en Technologie, European Society of Cataract and Refractive Surgeons, Fund for Scientific Research, Flanders, Belgium

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity		Just before surgery and upto 1 years after surgery	Yes
Primary	Conjunctivalization		Just before surgery and upto 1 years after surgery	Yes
Primary	Vascularization		Just before surgery and upto 1 years after surgery	Yes
Primary	Epithelialization		Just before surgery and upto 1 years after surgery	Yes
Secondary	Prolonged subsequent corneal graft survival time		1 year post corneal transplant	No