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
About this trial
This is an expanded access trial for Vascular Diseases
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
-
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
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
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Primary Completion Date
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Study Completion Date
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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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