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NCT03631056 Clinical Trial

Individual Patient Expanded Access for Human Acellular Vessel (HAV)

Vascular Diseases Clinical Trial

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT03631056
Other study ID # CLN-EA-IP
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date September 2023
Source Humacyte, Inc.
Contact Mauricio Berdugo, MD, MPH
Phone 919-313-9633
Email mberdugo@humacyte.com
Is FDA regulated No
Health authority
Study type Expanded Access

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

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.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Human Acellular Vessel (HAV)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Humacyte, Inc.
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