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

NCT03942250 | Completed DMC

• 1 other identifier: 2222018NCRRT
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Epidermolysis Bullosa; Chronic Skin Ulcer

Keywords

Epidermolysis Bullosa; Amniotic membrane

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  6 weeks

Secondary Outcomes (1)

• Patient complain (upon the weekly questionnaire)

  6 weeks

Study Arms (1)

Treated

EXPERIMENTAL

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

Biological: REGE pro dressing

Interventions

REGE pro dressing BIOLOGICAL

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

Treated

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients diagnosed as EB wounds must be chronic

You may not qualify if:

• Patients Must stop other line of treatment
• Exclude patients have:
• Autoimmune diseases
• Diabetes

Sponsors & Collaborators

• Egyptian Atomic Energy Authority: lead
• Waleed Nemr,Egyptian Atomic Energy Authority: collaborator

Study Sites (1)

Amniotic tissue lab

Cairo, 29, Egypt

Location

Related Publications (2)

• 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.

  PMID: 29023030 BACKGROUND

• 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.

  PMID: 20466177 RESULT

MeSH Terms

Conditions

Epidermolysis Bullosa

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vesiculobullous

Study Officials

• Nashwa K Radwan, PhD

  NATIONAL CENTER FOR RADIATION RESEARCH AND TECHNOLOGY

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of amniotic tissue laboratory, Principal Investigator

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: May 8, 2019
• Study Start: January 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2019
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

EG (1)