Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-01-01 @ 11:08 AM
Study NCT ID:
NCT03942250
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2018-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Uses of Irradiated Human Amniotic Membrane in the Treatment of Dystrophic Epidermolysis Bullosa Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004820', 'term': 'Epidermolysis Bullosa'}], 'ancestors': [{'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012872', 'term': 'Skin Diseases, Vesiculobullous'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-17', 'studyFirstSubmitDate': '2018-02-22', 'studyFirstSubmitQcDate': '2019-05-06', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lesion area', 'timeFrame': '6 weeks', '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).'}, {'measure': 'Clinical progression sings', 'timeFrame': '6 weeks', 'description': '* After the first application time: White transperent color of granulation tissue appeared.\n* After the second application time: color dense of granulation tissue increased and covered all over the wound.\n* After the third application time: granulation tissue thickness increased and appeared as a complete homogenous layer.\n* After the fourth application time: depending on lesion depth and size, granulation tissue turned to be pink to red color.\n* After the fifth and sexth application time: Skin layers development appeared.'}], 'secondaryOutcomes': [{'measure': 'Patient complain (upon the weekly questionnaire)', 'timeFrame': '6 weeks', '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epidermolysis Bullosa', 'Amniotic membrane'], 'conditions': ['Epidermolysis Bullosa', 'Chronic Skin Ulcer']}, 'referencesModule': {'references': [{'pmid': '29023030', 'type': 'BACKGROUND', '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.'}, {'pmid': '20466177', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the effect of human amniotic membrane as a weekly dressing on chronic wounds in Epidermolysis Bullosa (EB) patients.', 'detailedDescription': 'Dried human amniotic membrane dressing were obtained from National center for radiation research and technology, Egypt (NCRRT), under commercial name REGE pro.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1- Patients diagnosed as EB wounds must be chronic\n\nExclusion Criteria:\n\n1. Patients Must stop other line of treatment\n2. Exclude patients have:\n\n 1. Autoimmune diseases\n 2. Diabetes'}, 'identificationModule': {'nctId': 'NCT03942250', 'briefTitle': 'Uses of Irradiated Human Amniotic Membrane in the Treatment of Dystrophic Epidermolysis Bullosa Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Egyptian Atomic Energy Authority'}, 'officialTitle': 'Uses of Irradiated Human Amniotic Membrane in the Treatment of Dystrophic Epidermolysis Bullosa Patients', 'orgStudyIdInfo': {'id': '2222018NCRRT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treated', 'description': 'Patients who received REGE pro dressing on EB wounds lesion weekly for 10 weeks', 'interventionNames': ['Biological: REGE pro dressing']}], 'interventions': [{'name': 'REGE pro dressing', 'type': 'BIOLOGICAL', 'description': 'REGE pro is a dressing of dried human amniotic membrane sterilized by gamma radiation', 'armGroupLabels': ['Treated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Amniotic tissue lab', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Nashwa K Radwan, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NATIONAL CENTER FOR RADIATION RESEARCH AND TECHNOLOGY'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Egyptian Atomic Energy Authority', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Waleed Nemr,Egyptian Atomic Energy Authority', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of amniotic tissue laboratory, Principal Investigator', 'investigatorFullName': 'Nashwa Radwan', 'investigatorAffiliation': 'Egyptian Atomic Energy Authority'}}}}