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

Title: Mr.

First Name: I.E

Last Name: Volkov

Zip:

State: Moscow

Country: Russia

Institution: Institute of Transplantology and Artificial Organs, Ministry of Health

Telephone:

Email:

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

http://nikrrom.chat.ru/list1_en.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: Not available

5. Is this treatment part of a clinical trial?

Yes

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

26 children

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?

Rabbit

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: 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?    
Unknown
Which microbial agents have been tested in transplant recipients?     Unknown

Has this microbiological testing been done by a registered laboratory?     
Unknown
if yes, which?
if not, by whom?

What testing methods were used?
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?            6- 12 Months
Location of the clinical follow-up examination?
In the same clinic?
Yes
if yes, which?
Children Clinical Hospital
if not, where?

14. Have results been presented at a scientific congress?

Unknown

if yes, where?

15. Have results been published in a scientific journal?

Unknown

if yes, Where?

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

Unknown

17. Comment