1. Main Reference

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

Title: MD

First Name: Robert

Last Name: Montgomery

Address: 403 East 34th Street, 3rd floor

Zip: 10016

State: New York

Country: USA

Institution: NYU Langone Transplant Institute

Telephone: 646-501-2418

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?

Kidney failure

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

Country: USA

Timing: 12-04-2024

5. Is this treatment part of a clinical trial?

No

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

1

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?    
- Strain?    
- Where were the source animals kept?  
- Was it a closed facility?    

Genetic modification of source: transgenic source animals or knock-out source animals?
Other precautions: 
1-GE GalSafe™ pig (by Revivicor, Inc)

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?

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

Cells:

Tissues:

Organs: Kidney and thymus composite (“thymo-kidney”)

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?              

14. Have results been presented at a scientific congress?

Unknown

15. Have results been published in a scientific journal?

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

No

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
Patient initially on dialysis and ineligible for left ventricular assist device (LVAD). Became candidate for LVAD after decision of xenotransplantation. LVAD implanted on April 4, 2024, thymo-kidney transplanted on April 12, 2024. FDA approved for compassionate use. Xenograft removed on 11 May 2024.