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

Epidermolysis Bullosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03942250
• Other study ID #: 2222018NCRRT
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: February 2019

Study information

• Verified date: September 2023
• Source: Egyptian Atomic Energy Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Skin Ulcer
• Epidermolysis Bullosa
• Epidermolysis Bullosa Dystrophica
• Skin Ulcer

Intervention

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

Locations

Country	Name	City	State
Egypt	Amniotic tissue lab	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Egyptian Atomic Energy Authority	Waleed Nemr,Egyptian Atomic Energy Authority

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	6 weeks