Individual Patient Expanded Access for Human Acellular Vessel (HAV)

Status Available

Clinical Trial Summary

Individual patient expanded access requests may be considered for patients who have no other treatment options and are not eligible for an HAV clinical study

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03631056
Study type	Expanded Access
Source	Humacyte, Inc.
Contact	Mauricio Berdugo, MD, MPH
Phone	919-313-9633
Email	mberdugo@humacyte.com
Status	Available
Phase

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