Heart| Porcine | USA
1. Contact address(Person who provides information. This information will be treated confidentially)?
First Name: Bartley
Last Name: Griffith
Address: 110 South Paca Street, 7-S-190
Institution: University of Maryland Medical Center
2. What is the source of your information about human xenotransplantation practices?
3. What is the therapeutic purpose of this xenotransplantation treatment?
End-stage cardiac disease
4. Where and when is this human xenotransplantation practice taking place?
5. Is this treatment part of a clinical trial?
6. How many patients are included in this clinical trial?
7. What are the inclusion criteria for patient selection?
i. Duration on the waiting list? Unknown
ii. Life-threatening diseases without alternative therapy? Yes
iii. Is a protocol available? Unknown
8. What is the animal source of the xenotransplantation product?
Do you have information about source animals?
– Geographic origin?
– Where were the source animals kept?
– 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, UHeart™ pig (by Revivicor, Inc)
h) Other precautions:
10. Testing of safety
Do you have information about testing of safety?
11. What type of cells/tissues/organs was transplanted?
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:
Do you have information about transplant recipients?
14. Have results been presented at a scientific congress?
if yes, where?
15. Have results been published in a scientific journal?
if yes, Where?
16. Is this human clinical trial performed with governmental and/or institutional oversight and supervision?
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?
Emergency authorization by the U.S. FDA for compassionate use