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

Title: MD

First Name: IM

Last Name: Sauer

Zip:

State: Berlin

Country: Germany

Institution: Humboldt-University Berlin

Telephone:

Email: Igor.sauer@charite.de

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: Germany

Timing: Published in 2003

5. Is this treatment part of a clinical trial?

Yes

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

8

7. 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

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?

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?     
Unknown
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 be store?    
How often is the patient seen for follow-up       
How long are the patients followed?   3 years          
Location of the clinical follow-up examination?
In the same clinic?
Yes
if yes, which?
Charité -- Campus Virchow Klinikum
if not, where?

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?

Sauer IM et al. Clinical extracorporeal hybrid liver support-phase I study with primary porcine liver cells. Xenotransplantation 2003; 10.460-469

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

No

If yes, which?

17. Comment