Main Reference

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

Title: MD

First Name: Jayme

Last Name: Locke

Address: Lyons Harrison Research Building, Room 748, 701 19th St S,

Zip: 35233

State: Alabama

Country: USA

Institution: University of Alabam at Birmingham

Telephone: 205-934-2131

Email: jlocke@uabmc.edu

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

Publication, 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: 2021

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? Unknown

ii. Life-threatening diseases without alternative therapy? Unknown

iii. Is a protocol available? Unknown

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

Porcine

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

Yes

Source animals?

– Geographic origin?

– Species?

– Strain?

– Where were the source animals kept? Facility free of designated pathogens

– Was it a closed facility?

Under what type of husbandry conditions?
a) Quarantine period. No
b) Presence of other animals of the same or different species. No
c) Sentinel animal program. No
d) Veterinary care. No
e) Drugs administered No
f) Vaccinations No
g) Genetic modification of source: transgenic source animals or knock-out source animals? Yes, 10-GE pig by Revivicor,Inc
h) Other precautions:

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? Hepatitis E, Herpes virus gamma, Influenza A, Mycoplasm
Has this microbiological testing been done by a registered laboratory? University of Minnesota Veterinary Diagnostic Laboratory
if yes, which?
if not, by whom?
What testing methods were used? PCR, RT-PCR

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

How are the transplant recipients being monitored for infections?    
Unknown

Which microbial agents have been tested in transplant recipients?     


Has this microbiological testing been done by a registered laboratory?     
Unknown
if yes, which?
if not, by whom?

What testing methods were used?                 
What samples are taken and how often?
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?            Study terminated at 77h 32 minutes after reperfusion, 8 days
Location of the clinical follow-up examination?  
In the same clinic?
if yes, which?
if not, where?

14. Have results been presented at a scientific congress?

No

if yes, where?

15. Have results been published in a scientific journal?

Porrett PM, Orandi BJ, Kumar V et al. First clinical-grade

if yes, Where?

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

Institutional Animal Care and Use Committee of UAB

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

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

if yes, which?

19. Comment

Brain-dead deceased recipient