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

Title: MD

First Name: G.V

Last Name: Mazariegos

State: Pennsylvania

Country: USA

Institution: Thomas E Starzl Transplantation Institute

Telephone:

Email:

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: USA

Timing: Published in 2001

5. Is this treatment part of a clinical trial?

Yes

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

4

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?

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?

Mazariegos GV et al. Safety observations in phase I clinical evaluation of the Excorp Medical Bioartificial Liver Support System after the first four patients. ASAIO J. 2001;47:471-475

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

Unknown

If yes, which?

Unknown

17. Comment