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: NYU Transplant Associates, 200 Old Country Road, Suite 100, Mineola

Zip: 11501

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

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: 11-25-2024

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: 
10-GE Ukidney 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

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?

US Food and Drug Administration: approved by compassionate use

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 with difficult allograft match.Postsurgical observation for 11 days, discharged home on 06.12.2024. Off-label / experimental use of ravulizumab-cwvz (Ultomiris, Alxeion Pharmaceuticals Inc) and pegcetacoplan (Empaveli, Apellis Pharmaceuticals)