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.
Epidermolysis Bullosa With Mitten Hands
Biological: Cell transplantation
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Autologous Transplantation of Cultured Fibroblast on Amniotic Membrane for Mitten Hand Deformity in Patients With Epidermolysis Bullosa|
- Pain [ Time Frame: 1month ] [ Designated as safety issue: Yes ]Evaluation the pain reduction 1 month after cell transplantation by VAS scoring.
- Infection [ Time Frame: 1week ] [ Designated as safety issue: Yes ]Evaluation the symptoms of any infection in the site of transplantation during 1week after transplantation.
- Bleeding [ Time Frame: 1week ] [ Designated as safety issue: Yes ]Evaluation the presence of any bleeding at the site of transplantation during 1 week after transplantation.
- Healing [ Time Frame: 1month ] [ Designated as safety issue: Yes ]Evaluation the healing of ulcers 1month after transplantation base on changing the dressing time.
- new ulceration [ Time Frame: 3months ] [ Designated as safety issue: Yes ]Evaluation the new blister or ulceration during 3 to 6 months after transplantation.
- Range of motion [ Time Frame: 6months ] [ Designated as safety issue: Yes ]Evaluation the range of hand motion between 0 -110 for every fingers 6 months after transplantation.
|Study Start Date:||July 2010|
|Study Completion Date:||July 2013|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
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 Name: autologous transplantation of cultured fibroblast on amniotic membrane
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01908088
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of|
|Study Chair:||Hamid Gourabi, PhD||Head of Royan Institute|
|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|