Clinical trial NCT01908088: Autologous Transplantation of Cultured Fibroblast on Amniotic Membrane in Patients With Epidermolysis Bullosa
Official title: Autologous Transplantation of Cultured Fibroblast on Amniotic Membrane for Mitten Hand Deformity in Patients With Epidermolysis Bullosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Epidermolysis Bullosa With Mitten Hands
Keywords: Epidermolysis Bullosa mitten hand deformity autologous cultured fibroblast
amniotic membrane
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
Collaborators: name: Hazrat Fatemeh Hospital
First posted: 2013-07-25
Enrollment: 6
Sex: ALL
Minimum age (years): 5
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain
timeFrame: 1month
measure: Infection
timeFrame: 1week
measure: Bleeding
timeFrame: 1week
measure: Healing
timeFrame: 1month
Secondary outcomes:
measure: new ulceration
timeFrame: 3months
measure: Range of motion
timeFrame: 6months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Head of Royan Institute Cell Therapy Center
name: Nasser Aghdami, MD,PhD
role: STUDY_DIRECTOR
affiliation: Dermatogist,Depatment of Regenerative medicin of Royan Institute
name: Saeed Shafiyan, MD
role: STUDY_DIRECTOR
affiliation: Regenerative Medicine Department of Royan Institute
name: Zahra Orouji, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Plastic Surgoen, Hazrat Fatemeh Hospital
name: Kamal Seyed Forootan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Plastic Surgoen,Hazrat Fatemeh Hospital
name: Seyed Mohammad Javad Fatemi, MD
role: PRINCIPAL_INVESTIGATOR
References: