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

Title: Professor.

First Name: Robert Bartlett

Last Name: Elliott

Address: PO Box 23566 Hunters Conrner

Zip: 2155

State: Manukau, Auckland

Country: New Zealand

Institution: Living Cell Technologies

Telephone: +61 3 9813 5501

Email: info@lctglobal.com

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

Congress

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

Diabetes

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

Country: New Zealand

Timing: Not available

5. Is this treatment part of a clinical trial?

Yes

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

14 Patient

7. What are the inclusion criteria for patient selection?

i. Duration on the waiting list? Unknown

ii. Life-threatening diseases without alternative therapy? No

iii. Is a protocol available? No

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: Islets of Langerhans

Tissues:

Organs:

Others:

12.What type of exposure to xenogeneic cells was involved?

• Solid-organ Xenotransplantation: No
• Cellular Xenotransplantation: Yes
• Tissue Xenotransplantation: No
• Human cells exposed to xenogeneic Feeder cells: No
• Extracorporeal perfusion: No
• Encapsulation: Yes
• Other bioartificial isolation device:
• Others:

13. Transplant
Do you have information about transplant recipients?

Yes

How are the transplant recipients being monitored for infections?    
Blood plasma and peripheral blood marrow cells 
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?  PCR
What samples are taken and how often?
For how long will they be store?    
How often is the patient seen for follow-up      
How long are the patients followed?            9 Years
Location of the clinical follow-up examination?
In the same clinic?
Unknown
if yes, which?
if not, where?

14. Have results been presented at a scientific congress?

Yes

if yes, where?
10th Congress of the International Pancreas and Islet Transplantation Association in Geneva 2005. Elliot RB et al. Long term survival of alginate encapsulated piglet islets in a patient with type 1 diabetes (abstract OP-056)

15. Have results been published in a scientific journal?

Yes

if yes, Where?
Elliott RB et al. No evidence of infection with porcine and igneous retrovirus in recipients of encapsulated porcine islet xenografts. Cell Transplant 2000; 9:895-901

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

Unknown

17. Comment
Living Cell Technologies have two office: one in Australia and the other in New Zealand