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

Primary Purpose

Epidermolysis Bullosa, Chronic Skin Ulcer

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

REGE pro dressing

About this trial

This is an interventional treatment trial for Epidermolysis Bullosa focused on measuring Epidermolysis Bullosa, Amniotic membrane

Eligibility Criteria

12 Years - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

1- Patients diagnosed as EB wounds must be chronic

Exclusion Criteria:

Patients Must stop other line of treatment
Exclude patients have:
1. Autoimmune diseases
2. Diabetes

Sites / Locations

Amniotic tissue lab

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treated

Arm Description

Patients who received REGE pro dressing on EB wounds lesion weekly for 10 weeks

Outcomes

Primary Outcome Measures

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).

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03942250

First Posted

February 22, 2018

Last Updated

September 17, 2023

Sponsor

Egyptian Atomic Energy Authority

Collaborators

Waleed Nemr,Egyptian Atomic Energy Authority

1. Study Identification

Unique Protocol Identification Number

NCT03942250

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

January 2017 (Actual)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Egyptian Atomic Energy Authority

Collaborators

Waleed Nemr,Egyptian Atomic Energy Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epidermolysis Bullosa, Chronic Skin Ulcer

Keywords

Epidermolysis Bullosa, Amniotic membrane

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treated

Arm Type

Experimental

Arm Description

Patients who received REGE pro dressing on EB wounds lesion weekly for 10 weeks

Intervention Type

Biological

Intervention Name(s)

REGE pro dressing

Intervention Description

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

Primary Outcome Measure Information:

Title

Lesion area

Description

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

Title

Clinical progression sings

Description

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Patient complain (upon the weekly questionnaire)

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nashwa K Radwan, PhD

Organizational Affiliation

NATIONAL CENTER FOR RADIATION RESEARCH AND TECHNOLOGY

Official's Role

Study Director

Facility Information:

Facility Name

Amniotic tissue lab

City

Cairo

ZIP/Postal Code

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

29023030

Citation

Nemr W, Bashandy AS, Araby E, Khamiss O. Biological Activity Alterations of Human Amniotic Membrane Pre and Post Irradiation Tissue Banking. Pak J Biol Sci. 2016;19(7):289-298. doi: 10.3923/pjbs.2016.289.298.

Results Reference

background

PubMed Identifier

20466177

Citation

Lo V, Lara-Corrales I, Stuparich A, Pope E. Amniotic membrane grafting in patients with epidermolysis bullosa with chronic wounds. J Am Acad Dermatol. 2010 Jun;62(6):1038-44. doi: 10.1016/j.jaad.2009.02.048.

Results Reference

result

Learn more about this trial

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

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