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

NCT ID: NCT03942250

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epidermolysis Bullosa Chronic Skin Ulcer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treated

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

Group Type EXPERIMENTAL

REGE pro dressing

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

REGE pro dressing

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Waleed Nemr,Egyptian Atomic Energy Authority

UNKNOWN

Sponsor Role collaborator

Egyptian Atomic Energy Authority

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nashwa Radwan

Head of amniotic tissue laboratory, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nashwa K Radwan, PhD

Role: STUDY_DIRECTOR

NATIONAL CENTER FOR RADIATION RESEARCH AND TECHNOLOGY

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Amniotic tissue lab

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29023030 (View on PubMed)

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.

Reference Type RESULT
PMID: 20466177 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2222018NCRRT

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Amnion Wound Covering for Enhanced Wound Healing
NCT03754218 COMPLETED EARLY_PHASE1
Evaluating MMPs in Burns
NCT03148977 TERMINATED