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

Epidermolysis Bullosa With Mitten Hands Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01908088
• Other study ID #: Royan-skin-003
• Status: Completed
• Phase: Phase 1
• First received: July 23, 2013
• Last updated: July 24, 2013
• Start date: July 2010
• Est. completion date: July 2013

Study information

• Verified date: February 2010
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 25 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epidermolysis Bullosa
• Epidermolysis Bullosa With Mitten Hands

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Royan Institute	Hazrat Fatemeh Hospital

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Evaluation the pain reduction 1 month after cell transplantation by VAS scoring.	1month	Yes
Primary	Infection	Evaluation the symptoms of any infection in the site of transplantation during 1week after transplantation.	1week	Yes
Primary	Bleeding	Evaluation the presence of any bleeding at the site of transplantation during 1 week after transplantation.	1week	Yes
Primary	Healing	Evaluation the healing of ulcers 1month after transplantation base on changing the dressing time.	1month	Yes
Secondary	new ulceration	Evaluation the new blister or ulceration during 3 to 6 months after transplantation.	3months	Yes
Secondary	Range of motion	Evaluation the range of hand motion between 0 -110 for every fingers 6 months after transplantation.	6months	Yes

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