1. Main Reference

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

Title: MD

First Name: Yi

Last Name: Wang

Address:

Zip:

State: Hainan

Country: China

Institution: Second Affiliated Hospital and the Transplantation Institute

Telephone:

Email: wayne0108@126.com

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

Press release, scientific publication

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

Kidney failure

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

Country: China

Timing: 20-11-2022, 13-06-2023

5. Is this treatment part of a clinical trial?

No

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

2

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
- Strain?    
- Where were the source animals kept?   Facility free of designated pathogens
- Was it a closed facility?    Yes

Genetic modification of source: transgenic source animals or knock-out source animals?
Other precautions: 
4 or 5-GE pig (GTKO, CMAHKO, β4GalNT2KO, hCD55, +/- hTBM), by Clonorgan Biotechnology Co., Ltd

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

No

Can you give a list of microbial agents for which source animals have been tested?
Screening before transplantation : pCMV, porcine circovirus types 1/2/3, PERV-A/B/C, porcine lymphotropic herpesvirus 1/2/3, hepatitis E virus, influenza A, mycoplasma hyopneumoniae, porcine epidemic diarrhea virus, porcine deltacoronavirus, transmissible gastroenteritisvirus, porcine reproductive and respiratory syndrome virus. All were negative, except for PERV-A and B. 

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

Cells:

Tissues:

Organs: Kidney

Others:

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

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

For how long will they be taken?    
For how long will they be store?     
How often is the patient seen for follow-up     12 days   
How long are the patients followed?              

14. Have results been presented at a scientific congress?

Unknown

15. Have results been published in a scientific journal?

Cell Reports Medicine, 2024. DOI: 10.1016/j.xcrm.2024.101744

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

Ethics Committe of the Second Affiliated Hospital, Hainan Provincial Department of Science and Technology, Hainan Provincial Health Commission, Hainan Medical College

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
Two brain-dead recipients