Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-03-06 @ 2:31 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:
Humacyte, Inc.
Organization:
Study Overview
Official Title:
None
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Procedure for Requesting Expanded Access:
The 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.
General Criteria:
We 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.
Anticipated Timing:
If you contact Humacyte as described above, Humacyte anticipates that we will acknowledge receipt within ten (10) business days or less.
The 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.
General Criteria:
We 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.
Anticipated Timing:
If you contact Humacyte as described above, Humacyte anticipates that we will acknowledge receipt within ten (10) business days or less.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: