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

Autologous Transplantation of Cultured Fibroblast on Amniotic Membrane for Mitten Hand Deformity in Patients With Epidermolysis Bullosa

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.

Study Overview

• Status: Completed
• Conditions: Epidermolysis Bullosa With Mitten Hands
• Intervention / Treatment: Biological: Cell transplantation

Detailed Description

Epidermolysis Bullosa patients with mitten hand deformity were included. (based on inclusion & exclusion criteria) These patients should be offered for surgery to release the adhesions between fingers and MCP. When the consent form was accepted and the lab test was confirmed, a small skin biopsy was removed from retro auricle and fibroblast cells were separated and cultured. These cells were seeded on AM and the microbial test was done as evidence to prove the safety.

Under general anesthesia, when the hands adhesion was removed, the autologous fibroblast cultured on AM was transplanted to the both hands (specially the area without skin coverage) and the hands were dressed afterward.

The dressing was changed and the wound was checked regularly to detect any complications.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Royan Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Both genders Age: 5-25y No history of other systemic disease No history of other cell therapy method No infection in donor or recipient site HCV Ab/HIV Ab/ HBS Ag tests were negative

Exclusion Criteria:

• Age less than 5y or more than 25y. History of other systemic disease History of other cell therapy method Infection in donor or recipient site Positive Lab tests for contagious viral diseases Pregnancy or lactating History of malignancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: fibroblast transplant; Transplantation of autologous cultured fibroblast on amniotic membrane in patients with Epidermolysis Bullosa with mitten hand deformity	Biological: Cell transplantation; autologous transplantation of cultured fibroblast on amniotic membrane in patients with Epidermolysis Bullosa with mitten hands.; Other Names: autologous transplantation of cultured fibroblast on amniotic membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Evaluation the pain reduction 1 month after cell transplantation by VAS scoring.	1month
Infection	Evaluation the symptoms of any infection in the site of transplantation during 1week after transplantation.	1week
Bleeding	Evaluation the presence of any bleeding at the site of transplantation during 1 week after transplantation.	1week
Healing	Evaluation the healing of ulcers 1month after transplantation base on changing the dressing time.	1month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
new ulceration	Evaluation the new blister or ulceration during 3 to 6 months after transplantation.	3months
Range of motion	Evaluation the range of hand motion between 0 -110 for every fingers 6 months after transplantation.	6months

Collaborators and Investigators

• Sponsor: Royan Institute
• Collaborators: Hazrat Fatemeh Hospital
• Investigators: Study Director: Nasser Aghdami, MD,PhD, Head of Royan Institute Cell Therapy Center; Study Director: Saeed Shafiyan, MD, Dermatogist,Depatment of Regenerative medicin of Royan Institute; Principal Investigator: Zahra Orouji, MD, Regenerative Medicine Department of Royan Institute; Principal Investigator: Kamal Seyed Forootan, MD, Plastic Surgoen, Hazrat Fatemeh Hospital; Principal Investigator: Seyed Mohammad Javad Fatemi, MD, Plastic Surgoen,Hazrat Fatemeh Hospital

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: July 23, 2013
• First Submitted That Met QC Criteria: July 24, 2013
• First Posted (Estimate): July 25, 2013

Study Record Updates

• Last Update Posted (Estimate): July 25, 2013
• Last Update Submitted That Met QC Criteria: July 24, 2013
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: amniotic membrane; Epidermolysis Bullosa mitten hand deformity autologous cultured fibroblast
• Additional Relevant MeSH Terms: Skin Diseases; Congenital Abnormalities; Genetic Diseases, Inborn; Skin Diseases, Genetic; Skin Diseases, Vesiculobullous; Skin Abnormalities; Epidermolysis Bullosa
• Other Study ID Numbers: Royan-skin-003