Main Reference

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

Title: MD

First Name: Kefeng

Last Name: Dou

Address: 408-4 Changyingxilu, Xincheng, Xi’An

Zip: 710032

State: Shaanxi

Country: China

Institution: Xijing Hospital, Air Force Medical University

Telephone:

Email:

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

Press release, press article

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

End-stage liver disease

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

Country: China

Timing: 10-03-2024

5. Is this treatment part of a clinical trial?

No

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

7. What are the inclusion criteria for patient selection?

i. Duration on the waiting list?

ii. Life-threatening diseases without alternative therapy?

iii. Is a protocol available?

8. What is the animal source of the xenotransplantation product?

Pig

9.Source Animals
Do you have information about source animals?

Yes

Source animals?
- Geographic origin?    
- Species?    Bama miniature pig (Sus scrofa domestica)
- Strain?    
- Where were the source animals kept?  Pathogen-free facility
- Was it a closed facility?    Yes


Genetic modification of source: transgenic source animals or knock-out source animals?
Other precautions: 
6-GE liver by Chengdu Clonorgan Biotechnology Co. Ltd.

10. Testing of safety
Do you have information about testing of safety?

Yes

Can you give a list of microbial agents for which source animals have been tested?
"a dozen pathogens", including Streptococcus suis, Mycoplasma pneumoniae and  pCMV

11. What type of cells/tissues/organs was transplanted?

Cells:

Tissues:

Organs: Liver

Others:

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

• Solid-organ Xenotransplantation: Yes
• Cellular Xenotransplantation: No
• Tissue Xenotransplantation: Yes
• 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

For how long will they be taken?    
For how long will they be store?     
How often is the patient seen for follow-up       
How long are the patients followed?            10 days 

14. Have results been presented at a scientific congress?

Unknow

15. Have results been published in a scientific journal?

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

Yes

If yes, which?

Academic, ethics, transplantation and animal use committees

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

No

if yes, which?

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

No

if yes, which?

19. Comment
Brain-dead patient