Questionnaire for data collection
Person in charge of human xenotransplantation practice.
Title : Professor.
First Name: Michael
Last name : Breimer
Address : Dept of Surgery, Inst. of Clinical Sciences, Sahlgrenska Academy at University, of Gothenburg, Göte
Zip : 413 45 Göteborg
State : VG region
Country : Sweden
Institution : Dept of surgery
Telephone : +46 31 3421000
Email : michael.breimer@gu.se
What is the source of your information about human xenotransplantation practices?
own work
What is the therapeutic purpose of this xenotransplantation treatment?
Where and when is this human xenotransplantation practice taking place?
Country Sweden
Timing 1995
Is this treatment part of a clinical trial?
Yes
How many patients are included in this clinical trial?
2
What are the inclusion criteria for patient selection?
i. Duration on the waiting list? Volunter a
ii. Life-threatening diseases without alternative therapy? No
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? Yes
Source animals?
Geographic origin? Sweden
Species? pig
Strain? Swedish Yorkshire/Swedish dome
Where were the source animals kept?
Was it a closed facility? No
Under what type of husbandry conditions?
a) Quarantine period No
b) Presence of other animals of the same or different species
No
if yes, which?
c) Sentinel animal program
No
if yes, which?
d) Veterinary care
No
if yes, which?
e) Drugs administered
No
if yes, which?
f) Vaccinations
No
if yes, which?
g) Genetic modification of source: transgenic source animals or knock-out source animals?
No
if yes, which?
Other precautions :
Testing of safety : Do you have information about testing of safety? Yes
Can you give a list of microbial agents for which source animals have been tested? Described in detail in the first publication: Breimer et. al. Xenotransplantation 1996; 3: 328-339
Has this microbiological testing been done by a registered laboratory?
Yes
if yes, which?
Dept of Microbiology, Sahlgren
if not, by whom?
What testing methods were used?
What type of cells/tissues/organs was transplanted?
Cells:
Tissues:
Organs: Kidney
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? Routine clinical follow up
Which microbial agents have been tested in transplant recipients? PERV
Has this microbiological testing been done by a registered laboratory?
No
if yes, which?
if not, by whom?
Scientific collaboration published in The Lancet 1998; 352: 699-701 and Science 1999; 285: 1236-1241
What testing methods were used?
Serological or culture assay testing
PCR
What samples are taken and how often? blood up to 2 years after the trial
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?
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?
Yes
if yes, where?
several Transplantation and Xenotransplantation meetings
Have results been published in a scientific journal?
Yes
if yes, where?
Xenotransplantation 1996; 3: 328-339, Xenotransplantation 1996; 3: 340-353, The Lancet 1998; 352:699-701, Xenotransplantation 1998; 5: 176-183, Science 1999; 285: 1236-1241, Xenotransplantation 2000; 7: 177-180, Scand J Urology Nephrology 2001; 35: 54-61
Is this human clinical trial performed with governmental and/or institutional oversight and supervision?
Yes
if yes, which?
Ethical Committee of University of Göteborg
Was the trial approved by a public health authorities(ministry of health, governmental agency...)?
No
if yes, which?
Was the trial overseen by a public health authorities(ministry of health, governmental agency...)?
No
if yes, which?
Comment

The aim of this clinical scientific trial was to test 1. the effect of antibody removal on the xenogenic kidney perfusion 2. the humoral and cellular immune response in non-immunosuppressed human individuals challenged with pig xenoantigens present in the