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

Humacyte

Status

Conditions: End Stage Renal Disease on Dialysis; Vascular Diseases

Treatments: Biological: Acellular Tissue Engineered Vessel (ATEV)

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT07141641

CLN-EA-IP-2

Details and patient eligibility

About

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.

Full 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.

Sex

Volunteers: No Healthy Volunteers

Inclusion criteria

-

Exclusion criteria

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