Main Reference

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

Title: MD

First Name: Jeremy

Last Name: Goverman

Address:

Zip:

State: USA

Country:

Institution: XenoTherapeutics

Telephone:

Email: wawe01cn@yahoo.com.cn

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

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

Burns

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

Country: USA

Timing: 2018-2020

5. Is this treatment part of a clinical trial?

Yes

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

Unknwon

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?

Pig

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

No

Source animals?
- Geographic origin?
- Species? 
- Strain? 
- Where were the source animals kept? 
- Was it a closed facility? 

Under what type of husbandry conditions?
a) Quarantine period. Unknown
b) Presence of other animals of the same or different species. Unknown
if yes, which?
c) Sentinel animal program. Unknown
if yes, which?
d) Veterinary care. Unknown
if yes, which?
e) Drugs administered Unknown
if yes, which?
f) Vaccinations Unknown
if yes, which?
g) Genetic modification of source: transgenic source animals or knock-out source animals? GalT-KO
if yes, which?
Other precautions:

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

No

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

Cells:

Tissues: Skin

Organs:

Others:

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

• Solid-organ Xenotransplantation: No
• 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?

Unknwon

14. Have results been presented at a scientific congress?

No

if yes, where?

15. Have results been published in a scientific journal?

No

if yes, Where?

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

Yes

If yes, which?
US Food and Drug Administration

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

Yes

if yes, which?
US Food and Drug Administration

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

Yes

if yes, which?
US Food and Drug Administration

19. Comment