Cornea| Pig | China
1. Contact address(Person who provides information. This information will be treated confidentially)?
First Name: Wei
Last Name: Chen
Institution: School of Ophthalmology and Optometry, Wenzhou Medical University
2. What is the source of your information about human xenotransplantation practices?
3. What is the therapeutic purpose of this xenotransplantation treatment?
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? Unknown
iii. Is a protocol available? Unknown
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: Yes
- Human cells exposed to xenogeneic Feeder cells: No
- Extracorporeal perfusion: No
- Encapsulation: No
- Other bioartificial isolation device:
Do you have information about transplant recipients?
How are the transplant recipients being monitored for infections? Unknown Which microbial agents have been tested in transplant recipients? Unknown 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 Day 3 and 7; months 1, 3, 6 and 12 How long are the patients followed? 1 years 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?
if yes, where?
15. Have results been published in a scientific journal?
if yes, Where?
Xenotransplantation (manuscript submitted)
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…)?
if yes, which?
Center for Medical Device Evaluation of Chinese Food & Drug Administration (CFDA)
18.Was the trial overseen by a public health authorities(ministry of health, governmental agency…)?
if yes, which?