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Individual Patient Expanded Access for Human Acellular Vessel (HAV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03631056
Expanded Access Status : Available
First Posted : August 15, 2018
Last Update Posted : August 18, 2022
Sponsor:
Information provided by (Responsible Party):
Humacyte, Inc.

Study Description
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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 Intervention/treatment
Vascular Diseases Vascular System Injuries End Stage Renal Disease on Dialysis Biological: Human Acellular Vessel (HAV)

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 Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.

Resource links provided by the National Library of Medicine


Interventions
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Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

-

Exclusion Criteria:

-

Contacts and Locations
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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
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Contact: Mauricio Berdugo, MD, MPH 919-313-9633 ext 233 mberdugo@humacyte.com
Contact: Mark Tulchinskiy, MD, MBA 919-313-9633 mtulchinskiy@humacyte.com

Sponsors and Collaborators
Humacyte, Inc.
More Information
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Responsible Party: Humacyte, Inc.
ClinicalTrials.gov Identifier: NCT03631056    
Other Study ID Numbers: CLN-EA-IP
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: August 18, 2022
Last Verified: August 2022
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Vascular Diseases
Vascular System Injuries
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Male Urogenital Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Chronic Disease
Disease Attributes
Pathologic Processes
Cardiovascular Diseases
Wounds and Injuries