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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.

Sponsor: Royan Institute

Current Primary Outcome:

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

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

Original Secondary Outcome: Same as current

Information By: Royan Institute

Dates:
Date Received: July 23, 2013
Date Started: July 2010
Date Completion:
Last Updated: July 24, 2013
Last Verified: February 2010