Individual Patient Expanded Access for Acellular Tissue Engineered Vessel (ATEV) for Vascular Disease and Dialysis Access

• Conditions: Vascular Diseases; End Stage Renal Disease on Dialysis

• Registration Number: NCT07141641
• Lead Sponsor: Humacyte, Inc.

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 the Investigator's contact information so that Humacyte may follow up with the Investigator directly.

General Criteria:

The Humacyte Expanded Access Committee will evaluate and respond to each expanded-access request received 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:

Humacyte will acknowledgement receipt of each Investigator request within ten (10) business days or less.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-19
• Study First Submitted QC: 2025-08-19
• Study First Posted: 2025-08-26
• Last Update Submitted: 2025-09-08
• Last Update Posted: 2025-09-15

Recruitment & Eligibility

• Status: TEMPORARILY_NOT_AVAILABLE
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

-

Exclusion Criteria

-

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified