NCT00736307

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2007

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

July 15, 2011

Status Verified

April 1, 2010

Enrollment Period

1.8 years

First QC Date

August 14, 2008

Last Update Submit

July 14, 2011

Conditions

Limbal Stem Cell Deficiency

Keywords

limbal stem cell deficiency

Outcome Measures

Primary Outcomes (2)

  • Snellen visual acuity

    6 months

  • corneal epithelial integrity and stability

    6 months

Secondary Outcomes (2)

  • Impression cytology

    12 months

  • Extent of retarding recurrent neovascularisation

    12 months

Study Arms (1)

1

EXPERIMENTAL

Cultured limbal stem cells Transplantation

Procedure: Cultured limbal stem cells Transplantation

Interventions

Cultured limbal stem cells TransplantationPROCEDURE

Transplantation of cultivated limbal epithelium on amniotic membrane

Also known as: Transplantation
1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Royan Institute

Tehran, Tehran Province, 1665659911, Iran

Location

Labbafinejad Ophthalmic Research Center

Tehran, Tehran Province, 16666, Iran

Location

Related Links

MeSH Terms

Conditions

Limbal Stem Cell Deficiency

Interventions

Transplantation

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Hamid Gorabi, PhD

    Royan institute, Tehran, Iran

    STUDY CHAIR

  • Mohammadali Javadi, MD

    Labbafinejad Ophthalmic Research Center, Tehran, Iran

    STUDY CHAIR

  • Hossein Baharvand, PhD

    Royan institute, Tehran, Iran

    PRINCIPAL INVESTIGATOR

  • Alireza Baradaran, MD

    Labbafinejad, Ophthalmic Research Center, Tehran, Iran

    PRINCIPAL INVESTIGATOR

  • Marzieh Ebrahimi, PhD

    Royan Institute, Tehran, Iran

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 14, 2008

First Posted

August 15, 2008

Study Start

October 1, 2007

Primary Completion

July 1, 2009

Study Completion

October 1, 2009

Last Updated

July 15, 2011

Record last verified: 2010-04

Locations

IR(2)