Evaluation of transplantation of autologous cultured fibroblast on amniotic membrane for treatment of epidermolysis bullosa patients with mitten hand deformity

Phase 1

• Conditions: Epidermolysis Bullosa patients with mitten hand deformity.; Epidermolysis bullosa dystrophica; Q81.2

• Registration Number: IRCT20080728001031N28
• Lead Sponsor: Royan Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2021

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Epidermolysis Bullosa patients with mitten hand deformity
Patients with 2 to 30 years old

Exclusion Criteria

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety assessment of autologous transplantation of cultured fibroblast on amniotic membrane for healing of mitten hands. Timepoint: Patients' dressings were changed every 7 days until the wound was completely healed. Then the visits were done in 3, 6, 12 months and then annually. Method of measurement: Physical examination.;Histological evaluation of autologous transplantation of cultured fibroblast on amniotic membrane for healing of mitten hands. Timepoint: 6 month after transplantation. Method of measurement: Biopsy.