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

Title: MD

First Name: Achilles A.

Last Name: Demetriou

Zip:

State: California

Country: USA

Institution: Cedars-Sinai Medical Center

Telephone:

Email: demetriou@csmc.edu

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: 11 US and 9 European hospitals

Timing: Published in 2004

5. Is this treatment part of a clinical trial?

Yes

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

171

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?

Yes

How are the transplant recipients being monitored for infections?    

Which microbial agents have been tested in transplant recipients?     PERV

Has this microbiological testing been done by a registered laboratory?     
Yes
if yes, which?
Centers for Disease Control (Atlanta)
if not, by whom?

What testing methods were used?
 PCR
Serological or culture assay testing
What samples are taken and how often?
Blood Samples and 6 times
For how long will they be store?    1 year
For how long will they continue to be taken?    1 year
How often is the patient seen for follow-up       1 Year
How long are the patients followed?             1 Year
Location of the clinical follow-up examination?
In the same clinic?
No
if yes, which?
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?

Demetriou AA et al. Prospective, randomized, multicenter, controlled trial of a vioartificial liver in treating acute liver failure. Ann Sure. 2004 May; 239(5): 660-7

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

No

If yes, which?

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

if yes, which?

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

if yes, which?

19. Comment