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Effects of cell therapy in treatment of epidermolysis bullosa

Evaluation of the efficacy and safety of amniotic membrane seeded by allogenic skin cells on chronic wound of patients with dystrophic epidermolysis bullosa; phase II randomized clinical trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20080901001159N20
Enrollment
20
Registered
2018-05-04
Start date
2018-04-21
Completion date
Unknown
Last updated
2018-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidermolysis bullosa. Epidermolysis bullosa

Interventions

Intervention 1: Intervention group: Amniotic membrane seeded by allogenic fibroblast. Intervention 2: Control group: amniotic membrane.

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 20 Years

Inclusion criteria

Inclusion criteria: Patients with 2-20 years old Both sexes Dystrophic type of EB Multiple skin wounds which are recurrent during 6 months ago

Exclusion criteria

Exclusion criteria: Pregnancy or lactating Arterial or venous defects in recipient site Immune defficiency Hemolytic anemia Chronic malnutrition Respiratory system defects Diabetes Local infection of recipient site Cell transplantation of recipient site during last 1 year HBV, HCV, and HIV infection Any malignancy of recipient site

Design outcomes

Primary

MeasureTime frame
Wound extent (cm2). Timepoint: Before intervention, every week up to 1 month, and every month up to 6 months. Method of measurement: Image J software.

Secondary

MeasureTime frame
Safety. Timepoint: intervention start date up to 6 months. Method of measurement: Medical history and physical examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Bajouri

Iranian academic center for education culture and research

bajouri_md@yahoo.com+98 21 2356 2173

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026