Uses of Irradiated Human Amniotic Membrane in the Treatment of Dystrophic Epidermolysis Bullosa Patients

Egyptian Atomic Energy Authority8 enrolled

Overview

To evaluate the effect of human amniotic membrane as a weekly dressing on chronic wounds in Epidermolysis Bullosa (EB) patients.

Dried human amniotic membrane dressing were obtained from National center for radiation research and technology, Egypt (NCRRT), under commercial name REGE pro.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Epidermolysis Bullosa Chronic Skin Ulcer

Interventions

REGE pro dressingBIOLOGICAL

REGE pro is a dressing of dried human amniotic membrane sterilized by gamma radiation

Eligibility

Sex: ALLMin age: 12 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1- Patients diagnosed as EB wounds must be chronic Exclusion Criteria: 1. Patients Must stop other line of treatment 2. Exclude patients have: 1. Autoimmune diseases 2. Diabetes

Locations (1)

Amniotic tissue lab

Cairo, Egypt

Outcomes

Primary Outcomes

Lesion area

The lesion area from the first treatment is greater than 2 cm\^2 (grade 3, according to CTCAE v4.0), to the complete healing (= 0 cm\^2).

Time frame: 6 weeks

Clinical progression sings

* After the first application time: White transperent color of granulation tissue appeared. * After the second application time: color dense of granulation tissue increased and covered all over the wound. * After the third application time: granulation tissue thickness increased and appeared as a complete homogenous layer. * After the fourth application time: depending on lesion depth and size, granulation tissue turned to be pink to red color. * After the fifth and sexth application time: Skin layers development appeared.

Time frame: 6 weeks

Secondary Outcomes

Patient complain (upon the weekly questionnaire)

The quality of life is scored 0 (minimum) -100 (maximum), the pain reduction is scored 0-100 (as previous) from the first visit till 6 weeks.

Time frame: 6 weeks

Data from ClinicalTrials.gov

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