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

Title: MD

First Name: M.P

Last Name: Van Kerkove

State: Amsterdam

Country: Netherlands

Institution: Academic Medical Center, University of Amsterdam

Telephone:

Email: m.p.vandekerkhove@amc.uva.nl

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

Publication

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

Acute liver failure

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

Country: Italy

Timing: Published in 2002

5. Is this treatment part of a clinical trial?

Yes

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

7

7. 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

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

Pig

9.Source Animals
Do you have information about source animals?

No

10. Testing of safety
Do you have information about testing of safety?

No

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

Cells: Hepatocytes

Tissues:

Organs:

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?

No

14. Have results been presented at a scientific congress?

No

if yes, where?

15. Have results been published in a scientific journal?

Yes

if yes, Where?

Van de Kerkhove MP, Di Florio E, Scuderi V et al. Phase I clinical trial with the AMC-bioartificial liver. Int J Artif Organs 2002; 25:950-959.

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

Unknown

If yes, which?

17. Comment