Individual Patient Expanded Access for Acellular Tissue Engineered Vessel (ATEV) / Human Acellular Vessel (HAV)

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

• Registration Number: NCT03631056
• 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 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 Timeline

• Study First Submitted: 2018-08-10
• Study First Submitted QC: 2018-08-10
• Study First Posted: 2018-08-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21

Recruitment & Eligibility

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

Inclusion Criteria

Exclusion Criteria

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified