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Individual Patient Expanded Access for Human Acellular Vessel (HAV)

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ClinicalTrials.gov Identifier: NCT03631056
Expanded Access Status : Available
First Posted : August 15, 2018
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
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 HAV clinical study

Condition or disease
Vascular Diseases Vascular System Injuries End Stage Renal Disease on Dialysis

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 Type : Expanded Access
Expanded Access Type : Individual Patients

Resource links provided by the National Library of Medicine




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Criteria

Inclusion Criteria:

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03631056


Contacts
Contact: Angela Rose 919-313-9633 ext 171 expandedaccess@humacyte.com

Sponsors and Collaborators
Humacyte, Inc.

Responsible Party: Humacyte, Inc.
ClinicalTrials.gov Identifier: NCT03631056     History of Changes
Other Study ID Numbers: CLN-EA-IP
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Kidney Failure, Chronic
Vascular Diseases
Vascular System Injuries
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Cardiovascular Diseases
Wounds and Injuries