1. Contact address(Person who provides information. This information will be treated confidentially)?

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

2. What is the source of your information about human xenotransplantation practices?

own work

3. What is the therapeutic purpose of this xenotransplantation treatment?

4. Where and when is this human xenotransplantation practice taking place?

Country: Sweden

Timing: 1995

5. Is this treatment part of a clinical trial?

Yes

6. How many patients are included in this clinical trial?

2

7. What are the inclusion criteria for patient selection?

i. Duration on the waiting list? Volunteer a

ii. Life-threatening diseases without alternative therapy? No

iii. Is a protocol available? Yes

8. What is the animal source of the xenotransplantation product?

Pig

9.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?
Other precautions: 

10. 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?

11. What type of cells/tissues/organs was transplanted?

Cells:

Tissues:

Organs: Kidney

Others:

12.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 cells: No
• Extracorporeal perfusion: Yes
• Encapsulation: No
• Other bioartificial isolation device:
• Others:

13. 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

Location of the clinical follow-up examination?
In the same clinic?
No

14. Have results been presented at a scientific congress?

Yes

if yes, where?
Several Transplantation and Xenotransplantation meetings

15. 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

16. Is this human clinical trial performed with governmental and/or institutional oversight and supervision?

Yes

If yes, which?

Ethical Committee of University of Göteborg

17. Was the trial approved by a public health authorities(ministry of health, governmental agency…)?

No

if yes, which?

18.Was the trial overseen by a public health authorities(ministry of health, governmental agency…)?

No

if yes, which?

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