The Improvement of Limbal Stem Cell Deficiency (LSCD) in Unilateral Stem Cell Damage by Amniotic Membrane Extract Eye Drop (AMEED)

NCT02649621 | Completed Phase 1 DMC

• 1 other identifier: Royan-Eye-002
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

Corneal epithelial cells and limbal stem cells (LSC) are located in the limbus basal epithelium that are necessary for repair of corneal. About patients with deficient or absence of this area has been proposed various treatments such as limbal stem cell transplantation. This study is a prospective clinical trial to compare the improvement of limbal stem cell deficiency (LSCD) in vivo by using of Amniotic Membrane Extract Eye Drop (AMEED).

Conditions

Limbal Stem Cell Deficiency (LSCD)

Keywords

Limbal Stem Cell Deficiency Amniotic Membrane Extract Eye Drop in vivo cultivation

Outcome Measures

Primary Outcomes (3)

• Limbal defect size

  The measurement of limbal defect size by microscope 12 months after corneal surgery

  12 months

• Corneal epithelial integrity

  The measurement of Corneal epithelial integrity by microscope 12 months after corneal surgery

  12 months

• Corneal epithelial stability

  The measurement of Corneal epithelial stability by microscope 12 months after corneal surgery

  12 months

Secondary Outcomes (3)

• Vascularization

  12 months

• Transparency

  12 months

• Best spectacle corrected visual activity

  12 months

Study Arms (1)

Amniotic Membrane Extract Eye Drop recipient

EXPERIMENTAL

patients with limbal stem cell Deficiency who receive amniotic membrane transplantation and amniotic membrane extract eye drop as eye drop.

Biological: Amniotic Membrane Extract Eye Drop (AMEED)

Interventions

Amniotic Membrane Extract Eye Drop (AMEED) BIOLOGICAL

Use of use Amniotic Membrane Extract Eye Drop (AMEED) on in vivo cultured limbal stem cells in the treatment of unilateral corneal stem cell damage.

Amniotic Membrane Extract Eye Drop recipient

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient with unilateral chemical burn (grade III to up); estimation of chemical burns amount and classification was according to Dua.
• Without Age limitation

You may not qualify if:

• Lack of timely referral of patients for examinations
• Simultaneous use of other drugs that cause impairment of the data

Sponsors & Collaborators

• Royan Institute: lead

Related Links

• Related Info

MeSH Terms

Conditions

Limbal Stem Cell Deficiency

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Hamid Gourabi, PhD

  Head of Royan Institute

  STUDY CHAIR

• Marzieh Ebrahimi, PhD

  Department of Regenerative Biomedicine at Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.

  STUDY DIRECTOR

• Alireza Baradaran, MD

  Labafi Nejad Eye Research Center, Tehran, Iran

  STUDY DIRECTOR

• Mitra Akbari, MD

  Labafi Nejad Eye Research Center, Tehran, Iran

  PRINCIPAL INVESTIGATOR

• Niloufar Shayan, MSc

  Department of Stem Cells and Developmental Biology at Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.

  PRINCIPAL INVESTIGATOR

• Maryam Momeni, MSc

  Department of Stem Cells and Developmental Biology at Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 7, 2016
• Study Start: August 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 7, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share