Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency (LECT)
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| ClinicalTrials.gov Identifier: NCT00845117 |
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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
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Sponsor:
Ethisch Comité UZ Antwerpen
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
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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 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
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
Primary Outcome Measures :
- Visual Acuity [ Time Frame: Just before surgery and upto 1 years after surgery ]
- Conjunctivalization [ Time Frame: Just before surgery and upto 1 years after surgery ]
- Vascularization [ Time Frame: Just before surgery and upto 1 years after surgery ]
- Epithelialization [ Time Frame: Just before surgery and upto 1 years after surgery ]
Secondary Outcome Measures :
- Prolonged subsequent corneal graft survival time [ Time Frame: 1 year post corneal transplant ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| 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)
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 |
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:
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Aniridia, Steven Johnsons Syndrome, Ocular burns, Pterygium |