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Hemodialysis Fistula - Healing Genes
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Hemodialysis Fistula

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Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis

A Phase 3 Study to Compare the Efficacy and Safety of Humacyte’s Human Acellular Vessel With That of an Autologous Arteriovenous Fistula in Subjects With End Stage Renal Disease


Phase 3

DESCRIPTION:

Doctors at 28 study centers are seeking pediatric patients end-stage renal disease (ESRD) receiving hemodialysis who are eligible for creation of an arteriovenous fistula (AVF) for access. The study is investigating an engineered tissue graft that provides a vascular conduit, created from donor tissue that has all cells removed and will be implanted surgically. Half the patients will receive this engineered product and half will receive a standard form of fistula created from their own vein. The researchers hope this new form of fistula will remain patent (open) and more functional then the traditional AVF. Follow up will continue for up to 5 years.


PATIENT MUST:

  • Up to 18 year of age or older
  • Have ESRD and be receiving hemodialysis, eligible for AVF implant
  • Plan to under hemodialysis at a participating dialysis provider for at least 6 months after the fistula implant therapy
  • Have life expectancy of at least 2 years

THE STUDY INVOLVES:

  1. Prescreening to confirm eligibility of the patient to participate.
  2. Surgery to either implant the tissue graft vascular conduit or to have creation of a traditional AVF
  3. Follow up will continue for up to 5 years.

LOCATIONS AND CONTACTS:

The 28 locations participating in the study can be viewed here.

CONTACTS:

Angela Rose, MBA  |  919-313-9633 ext 185  |  [email protected]

Brant Hamel, PhD  |  919-313-9633 ext 245  |  [email protected]

 

SPONSOR INFORMATION:

Humacyte, Inc.

CTI Clinical Trial and Consulting Services

California Institute for Regenerative Medicine (CIRM)

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03183245

 

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