Questionnaire for data collection
Person in charge of human xenotransplantation practice.
Title : MD
First Name: IM
Last name : Sauer
Address :
Zip :
State : Berlin
Country : Germany
Institution : Humboldt-University Berlin
Telephone :
Email : igor.sauer@charite.de
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 Germany
Timing published in 2003
Is this treatment part of a clinical trial?
Yes
How many patients are included in this clinical trial?
8
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? Yes
How are the transplant recipients being monitored for infections? 8
Which microbial agents have been tested in transplant recipients? PERV
Has this microbiological testing been done by a registered laboratory?
Unknwon
if yes, which?
if not, by whom?
What testing methods were used?
Serological or culture assay testing
What samples are taken and how often? blood samples
For how long will they continue to be taken?
For how long will they be stored?
How often is the patient seen for follow-up?
How long are the patients followed? 3 yrd
Location of the clinical follow-up examination:
In the same clinic?
Yes
if yes, which?
Charité--Campus Virchow Klinikum
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?
Sauer IM et al. Clinical extracorporeal hybrid liver support-phase I study with primary porcine liver cells. Xenotransplantation 2003; 10.460-469.
Is this human clinical trial performed with governmental and/or institutional oversight and supervision?
No
if yes, which?
Comment