Questionnaire for data collection
Person in charge of human xenotransplantation practice.
Title : MD
First Name: G.V
Last name : Mazariegos
Address :
Zip :
State : Pennsylvania
Country : USA
Institution : Thomas E Starzl Transplantation Institute
Telephone :
Email :
What is the source of your information about human xenotransplantation practices?
Publication
What is the therapeutic purpose of this xenotransplantation treatment?
Acute liver failure
Where and when is this human xenotransplantation practice taking place?
Country USA
Timing Published in 2001
Is this treatment part of a clinical trial?
Yes
How many patients are included in this clinical trial?
4
What are the inclusion criteria for patient selection?
i. Duration on the waiting list?
ii. Life-threatening diseases without alternative therapy? Yes
iii. Is a protocol available? Yes
If yes, could you please send a copy?
What is the animal source of the xenotransplantation product?
Pig
Source animals Do you have information about source animals? No
Testing of safety : Do you have information about testing of safety? No
What type of cells/tissues/organs was transplanted?
Cells: Hepatocytes
Tissues:
Organs:
Others:
What type of exposure to xenogeneic cells was involved?
Solid-organ xenotransplantation: No
Cellular xenotransplantation: No
Tissue xenotransplantation: No
Human cells exposed to xenogeneic Feeder cell: No
Extracorporeal perfusion: Yes
Encapsulation: No
Other bioartificial isolation device:
Others:
Transplant Do you have information about transplant recipients? No
Have results been presented at a scientific congress?
No
if yes, where?
Have results been published in a scientific journal?
Yes
if yes, where?
Mazariegos GV et al. Safety observations in phase I clinical evaluation of the Excorp Medical Bioartificial Liver Support System after the first four patients. ASAIO J. 2001; 47:471–475.
Is this human clinical trial performed with governmental and/or institutional oversight and supervision?
Unknown
if yes, which?
Comment