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Autologous Transplantation of Cultured Fibroblast on Amniotic Membrane in Patients With Epidermolysis Bullosa

NCT01908088 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2013-07-25

No results posted yet for this study

Summary

Epidermolysis Bullosa (EB) is a blistering disease that is caused by defective anchoring fibrils and hemidesmosome in basement membrane of the skin layer. EB is inherited either autosomal or recessive and has 3 types. Recessive Dystrophic Epidermolysis Bullosa (RDEB) is severe with some morbidity such as mitten hand deformity.

The management of these patients is very difficult because no effective treatment has been known yet.

The EB patients with mitten hand deformity need surgery to have a biologic dressing for areas of hand which is without the skin. In this study the investigators assess the safety of autologous transplantation of cultured fibroblast on amniotic membrane (AM,as coverage) for them.

Conditions

  • Epidermolysis Bullosa With Mitten Hands

Interventions

BIOLOGICAL

Cell transplantation

autologous transplantation of cultured fibroblast on amniotic membrane in patients with Epidermolysis Bullosa with mitten hands.

Sponsors & Collaborators

  • Hazrat Fatemeh Hospital

    collaborator UNKNOWN

  • Royan Institute

    lead OTHER_GOV

Principal Investigators

  • Hamid Gourabi, PhD · Head of Royan Institute

  • Nasser Aghdami, MD,PhD · Head of Royan Institute Cell Therapy Center

  • Saeed Shafiyan, MD · Dermatogist,Depatment of Regenerative medicin of Royan Institute

  • Zahra Orouji, MD · Regenerative Medicine Department of Royan Institute

  • Kamal Seyed Forootan, MD · Plastic Surgoen, Hazrat Fatemeh Hospital

  • Seyed Mohammad Javad Fatemi, MD · Plastic Surgoen,Hazrat Fatemeh Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-09-30
Completion
2013-07-31

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01908088 on ClinicalTrials.gov