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Individual Patient Expanded Access for Human Acellular Vessel (HAV)

Primary Purpose

Vascular Diseases, Vascular System Injuries, End Stage Renal Disease on Dialysis

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Human Acellular Vessel (HAV)
Sponsored by
Humacyte, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Vascular Diseases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)

Inclusion Criteria:

-

Exclusion Criteria:

-

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    August 10, 2018
    Last Updated
    September 12, 2023
    Sponsor
    Humacyte, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03631056
    Brief Title
    Individual Patient Expanded Access for Human Acellular Vessel (HAV)
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Humacyte, Inc.

    4. Oversight

    5. Study Description

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vascular Diseases, Vascular System Injuries, End Stage Renal Disease on Dialysis

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    Human Acellular Vessel (HAV)

    10. Eligibility

    Eligibility Criteria
    Inclusion Criteria: - Exclusion Criteria: -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mauricio Berdugo, MD, MPH
    Phone
    919-313-9633
    Ext
    233
    Email
    mberdugo@humacyte.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mark Tulchinskiy, MD, MBA
    Phone
    919-313-9633
    Email
    mtulchinskiy@humacyte.com

    12. IPD Sharing Statement

    Learn more about this trial

    Individual Patient Expanded Access for Human Acellular Vessel (HAV)

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