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

This study has been completed.
Sponsor:
Collaborators:
Small Business Developing Center
Labafi Nejad Eye Research Center
Information provided by:
Royan Institute
ClinicalTrials.gov Identifier:
NCT00736307
First received: August 14, 2008
Last updated: July 14, 2011
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Limbal Stem Cell Deficiency
Procedure: Cultured limbal stem cells Transplantation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transplantation of Ex-Vivo Expanded Human Limbal Epithelial Stem Cells (LSC) on Amniotic Membrane (AM) for Limbal Stem Cell Deficiency (LSCD)

Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • Snellen visual acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • corneal epithelial integrity and stability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Impression cytology [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Extent of retarding recurrent neovascularisation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: October 2007
Study Completion Date: October 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cultured limbal stem cells Transplantation
Procedure: Cultured limbal stem cells Transplantation
Transplantation of cultivated limbal epithelium on amniotic membrane
Other Name: Transplantation

Detailed Description:

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736307

Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of, 1665659911
Labbafinejad Ophthalmic Research Center
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Royan Institute
Small Business Developing Center
Labafi Nejad Eye Research Center
Investigators
Study Chair: Hamid Gorabi, PhD Royan institute, Tehran, Iran
Study Chair: Mohammadali Javadi, MD Labbafinejad Ophthalmic Research Center, Tehran, Iran
Principal Investigator: Hossein Baharvand, PhD Royan institute, Tehran, Iran
Principal Investigator: Alireza Baradaran, MD Labbafinejad, Ophthalmic Research Center, Tehran, Iran
Study Director: Marzieh Ebrahimi, PhD Royan Institute, Tehran, Iran
  More Information

Additional Information:
No publications provided

Responsible Party: Hamid Gourabi/ Chief, Royan Institute
ClinicalTrials.gov Identifier: NCT00736307     History of Changes
Other Study ID Numbers: ROYAN-EYE-001
Study First Received: August 14, 2008
Last Updated: July 14, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by Royan Institute:
limbal stem cell deficiency

ClinicalTrials.gov processed this record on April 21, 2014