Questionnaire data

Islets of Langerhans | Pig | Russia

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

Title: Professor.

First Name: Robert Bartleet

Last Name: Elliott

Address: Pacific Tower Suite 2.11/737 Burwood Rd

Zip: Hawthorn VIC 3122

State:

Country: Australia

Institution: Living Cell Technologies

Telephone: +61 3 9813 5501

Email: lct@lctglobal.com

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

1) Internet: www.lctglobal.com
2) BBC News
: http://news.bbc.co.uk/2/hi/health/6353811.stm
3) http:// www.newscientist.com/article/mg19826515.400-pig-cell-transplants-help-people-with-diabetes.html

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

Diabetes

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

Country: Russia

Timing: Trial is on going

5. Is this treatment part of a clinical trial?

Yes

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

4 Patients

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?

No

14. Have results been presented at a scientific congress?

Yes

if yes, where?
International Diabetes Federation in Wellington, New Zealand, on 31 March

15. Have results been published in a scientific journal?

No

if yes, Where?

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

Yes

If yes, which?

Unknown

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

Yes

if yes, which?
Ministry of health of Russia

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

Yes

if yes, which?
Ministry of health of Russia

19. Comment
This clinical trial is planned by an Australian company to be carried out in Russia