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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.

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

Clinicaltrials.gov identifier NCT03942250

Recruitment Status Completed

First Posted May 8, 2019

Last update posted June 27, 2019

Study Description

Brief summary:

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

  • Condition or Disease:Epidermolysis Bullosa
    Chronic Skin Ulcer
  • Intervention/Treatment: Biological: REGE pro dressing
  • Phase: N/A
Detailed Description

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

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 8 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Uses of Irradiated Human Amniotic Membrane in the Treatment of Dystrophic Epidermolysis Bullosa Patients
  • Actual Study Start Date: January 2017
  • Actual Primary Completion Date: December 2017
  • Actual Study Completion Date: February 2019
Arms and interventions
Arm Intervention/treatment
Experimental: Treated
Patients who received REGE pro dressing on EB wounds lesion weekly for 10 weeks
Biological: REGE pro dressing
REGE pro is a dressing of dried human amniotic membrane sterilized by gamma radiation
Outcome Measures
  • Primary Outcome Measures: 1. Lesion area [ Time Frame: 6 weeks ]
    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).
  • 2. Clinical progression sings [ Time Frame: 6 weeks ]
    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.
  • Secondary Outcome Measures: 1. Patient complain (upon the weekly questionnaire) [ Time Frame: 6 weeks ]
    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.
Eligibility Criteria
  • Ages Eligible for Study: 12 to 45 Years (Child, Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

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

Contacts and Locations
Contacts
Locations

Egypt
Amniotic tissue lab
Cairo

Sponsors and Collaborators

Egyptian Atomic Energy Authority

Investigators

Study Director: Nashwa K Radwan, PhD NATIONAL CENTER FOR RADIATION RESEARCH AND TECHNOLOGY

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