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

Limbal Stem Cell Deficiency Clinical Trial

Official title:

Transplantation of Ex-Vivo Expanded Human Limbal Epithelial Stem Cells (LSC) on Amniotic Membrane (AM) for Limbal Stem Cell Deficiency (LSCD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736307
• Other study ID #: ROYAN-EYE-001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 14, 2008
• Last updated: July 14, 2011
• Start date: October 2007
• Est. completion date: October 2009

Study information

• Verified date: April 2010
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Limbal Stem Cell Deficiency

Intervention

Procedure:
• Cultured limbal stem cells Transplantation
Transplantation of cultivated limbal epithelium on amniotic membrane

Locations

Country	Name	City	State
Iran, Islamic Republic of	Labbafinejad Ophthalmic Research Center	Tehran
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (3)

Lead Sponsor	Collaborator
Royan Institute	Labafi Nejad Eye Research Center, Small Business Developing Center

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Snellen visual acuity		6 months	No
Primary	corneal epithelial integrity and stability		6 months	Yes
Secondary	Impression cytology		12 months	Yes
Secondary	Extent of retarding recurrent neovascularisation		12 months	Yes

External Links

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