Questionnaire for data collection
Person in charge of human xenotransplantation practice.
Title : MD
First Name: Achilles A.
Last name : Demetriou
Address :
Zip :
State : California
Country : USA
Institution : Cedars-Sinai Medical Center
Telephone :
Email : demetriou@csmc.edu
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 11 US and 9 European hospitals
Timing published in 2004
Is this treatment part of a clinical trial?
Yes
How many patients are included in this clinical trial?
171
What are the inclusion criteria for patient selection?
i. Duration on the waiting list? unknown
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? Yes
How are the transplant recipients being monitored for infections?
Which microbial agents have been tested in transplant recipients? PERV
Has this microbiological testing been done by a registered laboratory?
Yes
if yes, which?
Centers for Disease Control (Atlanta)
if not, by whom?
What testing methods were used?
PCR
Serological or culture assay testing
What samples are taken and how often? blood samples and 6 times
For how long will they continue to be taken? one year
For how long will they be stored? unknown
How often is the patient seen for follow-up? one year
How long are the patients followed? one year
Location of the clinical follow-up examination:
In the same clinic?
No
if yes, which?
if not, where?
Have results been presented at a scientific congress?
No
if yes, where?
Have results been published in a scientific journal?
Yes
if yes, where?
Demetriou AA et al. Prospective, randomized, multicenter, controlled trial of a bioartificial liver in treating acute liver failure. Ann Surg. 2004 May; 239(5):660-7.
Is this human clinical trial performed with governmental and/or institutional oversight and supervision?
No
if yes, which?
Comment