Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-01-29 @ 11:53 PM
Study NCT ID:
NCT03631056
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2025-08-24
First Post:
2018-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individual Patient Expanded Access for Acellular Tissue Engineered Vessel (ATEV) for Vascular System Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057772', 'term': 'Vascular System Injuries'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}, 'nPtrsToThisExpAccNctId': 2}, 'statusModule': {'overallStatus': 'APPROVED_FOR_MARKETING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2018-08-10', 'studyFirstSubmitQcDate': '2018-08-10', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Vascular System Injuries']}, 'descriptionModule': {'briefSummary': 'Individual patient expanded access requests may be considered for patients who have no other treatment options and are not eligible for an ATEV clinical study', 'detailedDescription': "Procedure for Requesting Expanded Access:\n\nThe treating physician requesting expanded access must contact Humacyte directly with the basis for the request. Please include your contact information so that Humacyte may follow up with you directly.\n\nGeneral Criteria:\n\nWe will evaluate and respond to each expanded-access request that we receive on a case-by-case basis. Humacyte will consider the nature of the request, the patient's health, the available medical and scientific information about the investigational product, the balance of risk and potential benefit to the patient, the availability of investigational product, and the potential regulatory impact.\n\nAnticipated Timing:\n\nIf you contact Humacyte as described above, Humacyte anticipates that we will acknowledge receipt within ten (10) business days or less."}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03631056', 'briefTitle': 'Individual Patient Expanded Access for Acellular Tissue Engineered Vessel (ATEV) for Vascular System Injuries', 'organization': {'class': 'INDUSTRY', 'fullName': 'Humacyte, Inc.'}, 'orgStudyIdInfo': {'id': 'CLN-EA-IP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Acellular Tissue Engineered Vessel (ATEV) / Human Acellular Vessel (HAV)', 'type': 'BIOLOGICAL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Humacyte, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}