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Completed

NCT Number: NCT00845117

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.

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Key information

Conditions

Limbal Stem Cell Deficiency Aniridia Chemically-Induced Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Conjunctival Diseases Corneal Diseases Dermatitis Drug Eruptions Drug Hypersensitivity Drug-Related Side Effects and Adverse Reactions Erythema Erythema Multiforme Eye Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Iris Diseases Mouth Diseases Pterygium Skin Diseases Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases Stevens-Johnson Syndrome Stomatitis Stomatognathic Diseases Uveal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Antwerp

Antwerp, Edegem, 2650, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cultivated limbal stem cell graft transplantation

Procedure

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 outcomes

  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 outcomes

  1. Prolonged subsequent corneal graft survival time

    Time frame: 1 year post corneal transplant

Sponsors and collaborators

Lead sponsor

Veerle Van Gerwen

Other

Collaborators

  • Agentschap voor Innovatie door Wetenschap en Technologie
  • European Society of Cataract and Refractive Surgeons
  • Fund for Scientific Research, Flanders, Belgium

Registry information

Acronym: LECT

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Feb 18, 2009
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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