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

September 17, 2023 updated by: Nashwa Radwan, Egyptian Atomic Energy Authority
To evaluate the effect of human amniotic membrane as a weekly dressing on chronic wounds in Epidermolysis Bullosa (EB) patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 29
        • Amniotic tissue lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 weeks
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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Egyptian Atomic Energy Authority

Collaborators

Waleed Nemr,Egyptian Atomic Energy Authority

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

February 22, 2018

First Submitted That Met QC Criteria

May 6, 2019

First Posted (Actual)

May 8, 2019

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 17, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2222018NCRRT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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