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

Phase 1

Completed

• Conditions: Epidermolysis Bullosa With Mitten Hands
• Interventions: Biological: Cell transplantation

• Registration Number: NCT01908088
• Lead Sponsor: Royan Institute

Brief 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.

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 Timeline

• Status Verified: 2010-02
• Study Start: 2010-07
• Primary Completion: 2012-09
• Study Completion: 2013-07
• Study First Submitted: 2013-07-23
• Study First Submitted QC: 2013-07-24
• Last Update Submitted: 2013-07-24
• Study First Posted: 2013-07-25
• Last Update Posted: 2013-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
fibroblast transplant	Cell transplantation	Transplantation of autologous cultured fibroblast on amniotic membrane in patients with Epidermolysis Bullosa with mitten hand deformity

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of