Autologous Transplantation of Cultivated Limbal Stem Cells on Amniotic Membrane in Limbal Stem Cell Deficiency (LSD) Patients

LSD

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, and long term outcomes of ex vivo cultured limbal stem cell on amniotic membrane transplantation for corneal surface reconstruction in cases of partial and sever limbal stem cell deficiency.

Intervention / Treatment

  • Cultured limbal stem cells Transplantation (PROCEDURE)
    Transplantation of cultivated limbal epithelium on amniotic membrane

Condition or Disease

  • Limbal Stem Cell Deficiency

Phase

Study Design

Study type: INTERVENTIONAL
Status: Completed
Study results: No Results Available
Age: 18 Years to 75 Years
Enrollment: 10 (ACTUAL)
Allocation: N/A
Primary Purpose: Treatment

Masking

Clinical Trial Dates

Start date: Oct 01, 2007
Primary Completion: Jul 01, 2009 ACTUAL
Completion Date: Oct 01, 2009 ACTUAL
Study First Posted: Aug 15, 2008 ESTIMATED
Last Updated: Jul 14, 2011

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Ocular surface is composed of corneal and conjunctival epithelial cells. Normal cornea is essential for normal vision. Defects in renewal and repair of ocular surface as a result of limbal stem cell deficiency are now known to cause varying ocular surface morbidity including persistent photophobia, repeated and persistent surface breakdown and overt conjunctivalisation of the cornea. Restoring ocular health in these eyes has traditionally been frustrating. Ex vivo cultured limbal epithelial stem cells have been used successfully to treat limbal stem cell deficiency. Ex-vivo limbal stem cell allograft transplantation is achieved by harvesting limbal corneal tissue from donor eyes (either matched living relatives or cadaveric donors). The donor stem cells are obtained by excising a small area of the conjunctiva at the limbus and are a minor procedure. The tissue so obtained is then grown in tissue culture and once the cells have multiplied sufficiently, small sheets are transplanted on to the affected eye(s), backed with an amniotic membrane. The surgery is undertaken under either local or general anesthesia.

Eligibility Criteria

Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: Yes

Inclusion Criteria:

* Patient with unilateral limbal stem cell insufficiency and totally corneal vascularization
* Presence of Goblet cells on the cornea
* Minimum tear was about 5 mm
* Minimum duration of deficiency was 3 years
* Vision was Light Perception

Exclusion Criteria:

* Systemic disease affecting both eyes such as Stevens-Johnson syndrome

Primary Outcomes
  • Snellen visual acuity 6 months
  • corneal epithelial integrity and stability 6 months
Secondary Outcomes
  • Impression cytology 12 months
  • Extent of retarding recurrent neovascularisation 12 months

More Details

NCT Number: NCT00736307
Other IDs: ROYAN-EYE-001
Study URL: https://clinicaltrials.gov/study/NCT00736307
Last updated: Sep 29, 2023