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

Title: Mr.

First Name: S.D.

Last Name: Nikonov

State: St-petersburg

Country: Russia

Institution:

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?

Pulmonary tuberculosis

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

Country: Russia

Timing: 1990 and 1991

5. Is this treatment part of a clinical trial?

Yes

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

113

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? 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:

Tissues:

Organs:

Others: Spleen

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. Do you have information about transplant recipients?

No

14. Have results been presented at a scientific congress?

Unknown

if yes, where?

15. Have results been published in a scientific journal?

Yes

if yes, Where?

(1) Nikonov S.D. et al. use of xenogeneic splendid perfusate in the complex treatment of patients with destructive pulmonary tuberculosis. Probl. Tuberk. 1990;(10): 10-2.

(2)Nikonov S.D. et al. Initial experience with the use of a xeno-spleen perfusate in the treatment of patients with extensive pro-destructive diseases of the lungs and pleura. Grub. Serdechnososudistaia Khir. 1991; (2): 42-5

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

Unknown

19. Comment