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Completed

NCT Number: NCT01908088

Autologous Transplantation of Cultured Fibroblast on Amniotic Membrane 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.

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Key information

Age range

5 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Royan Institute

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cell transplantation

Biological

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

Primary outcomes

  1. Pain

    Time frame: 1month

    Evaluation the pain reduction 1 month after cell transplantation by VAS scoring.

  2. Infection

    Time frame: 1week

    Evaluation the symptoms of any infection in the site of transplantation during 1week after transplantation.

  3. Bleeding

    Time frame: 1week

    Evaluation the presence of any bleeding at the site of transplantation during 1 week after transplantation.

  4. Healing

    Time frame: 1month

    Evaluation the healing of ulcers 1month after transplantation base on changing the dressing time.

Secondary outcomes

  1. new ulceration

    Time frame: 3months

    Evaluation the new blister or ulceration during 3 to 6 months after transplantation.

  2. Range of motion

    Time frame: 6months

    Evaluation the range of hand motion between 0 -110 for every fingers 6 months after transplantation.

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Collaborators

  • Hazrat Fatemeh Hospital

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Jul 25, 2013
Registry last updated
Jul 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.