Hepatocytes | Pig | 11 US and 9 European hospitals
1. Contact address(Person who provides information. This information will be treated confidentially)?
First Name: Achilles A.
Last Name: Demetriou
Institution: Cedars-Sinai Medical Center
2. What is the source of your information about human xenotransplantation practices?
3. What is the therapeutic purpose of this xenotransplantation treatment?
Acute liver failure
4. Where and when is this human xenotransplantation practice taking place?
Country: 11 US and 9 European hospitals
Timing: Published in 2004
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? Yes
8. What is the animal source of the xenotransplantation product?
Do you have information about source animals?
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: No
- Cellular Xenotransplantation: No
- Tissue Xenotransplantation: No
- Human cells exposed to xenogeneic Feeder cells: No
- Extracorporeal perfusion: Yes
- Encapsulation: No
- Other bioartificial isolation device:
Do you have information about transplant recipients?
How are the transplant recipients being monitored for infections? Which microbial agents have been tested in transplant recipients? PERV Has this microbiological testing been done by a registered laboratory? Yes if yes, which? Centers for Disease Control (Atlanta) if not, by whom? What testing methods were used? PCR Serological or culture assay testing What samples are taken and how often? Blood Samples and 6 times For how long will they be store? 1 year For how long will they continue to be taken? 1 year How often is the patient seen for follow-up 1 Year How long are the patients followed? 1 Year Location of the clinical follow-up examination? In the same clinic? No if yes, which? if not, where?
14. Have results been presented at a scientific congress?
if yes, where?
15. Have results been published in a scientific journal?
if yes, Where?
Demetriou AA et al. Prospective, randomized, multicenter, controlled trial of a vioartificial liver in treating acute liver failure. Ann Sure. 2004 May; 239(5): 660-7
16. Is this human clinical trial performed with governmental and/or institutional oversight and supervision?
If yes, which?
17. Was the trial approved by a public health authorities(ministry of health, governmental agency…)?
if yes, which?
18.Was the trial overseen by a public health authorities(ministry of health, governmental agency…)?
if yes, which?