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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00845117
Other study ID # EC 7/28/153
Secondary ID
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


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
See also
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Completed NCT00736307 - Autologous Transplantation of Cultivated Limbal Stem Cells on Amniotic Membrane in Limbal Stem Cell Deficiency (LSD) Patients Phase 1/Phase 2
Not yet recruiting NCT06412718 - Validation of Human Drugs Target of Repurposed Drugs and Novel Therapies
Available NCT02149732 - Clinical Trial on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation Phase 1/Phase 2
Recruiting NCT06452316 - Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency Phase 1
Terminated NCT02579993 - ABCB5 as a Prognostic Marker in Survival of Cultivated Limbal Stem Cell Transplantation N/A
Recruiting NCT03943797 - Cultivated Autologous Oral Mucosal Epithelial Transplantation Phase 1
Active, not recruiting NCT03549299 - Allogeneic ABCB5-positive Limbal Stem Cells for Treatment of LSCD Phase 1/Phase 2
Completed NCT03217435 - Corneal Epithelial Allograft From Living-related Donor for LSCD N/A
Recruiting NCT03217487 - Corneal Epithelial Autograft for LSCD N/A
Enrolling by invitation NCT03015779 - Transplantation of Autologous Oral Mucosal Epithelial Stem Cell Sheet for Treating Limbal Stem Cell Deficiency Disease Phase 1/Phase 2
Active, not recruiting NCT02739113 - Cultivated Autologous Oral Mucosal Epithelial Transplantation for the Treatment of Ocular Surface Diseases Phase 1/Phase 2
Not yet recruiting NCT06265298 - Implementation of a Protocol for the Transdifferentiation of Buccal Mucosal Epithelium Into Corneal Epithelium N/A
Recruiting NCT01756365 - Autologous Cultured Corneal Epithelium (CECA) for the Treatment of Limbal Stem Cell Deficiency N/A
Completed NCT02592330 - Limbal Stem Cell Deficiency (LSCD) Treatment With Cultivated Stem Cell (CALEC) Graft Phase 1/Phase 2
Recruiting NCT02318485 - Limbal Epithelial Stem Cell Transplantation: a Phase II Multicenter Trial Phase 2
Withdrawn NCT01489501 - Multicenter Study of CAOMECS Transplantation to Patients With Total Limbal Stem Cell Deficiency Phase 3