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
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|Condition or disease||Intervention/treatment|
|Vascular Diseases Vascular System Injuries End Stage Renal Disease on Dialysis||Biological: Human Acellular Vessel (HAV)|
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.
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.
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|
|See clinical trials of the intervention/treatment in this expanded access record.|
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.
|Ages Eligible for Study:||Child, Adult, Older Adult|
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
|Contact: Mauricio Berdugo, MD, MPH||919-313-9633 ext firstname.lastname@example.org|
|Contact: Mark Tulchinskiy, MD, MBAemail@example.com|
|Responsible Party:||Humacyte, Inc.|
|Other Study ID Numbers:||
|First Posted:||August 15, 2018 Key Record Dates|
|Last Update Posted:||August 18, 2022|
|Last Verified:||August 2022|
Kidney Failure, Chronic
Vascular System Injuries
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Male Urogenital Diseases
Renal Insufficiency, Chronic
Wounds and Injuries