Cornea| Pig | China

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

First Name: Wei

Last Name: Chen

Address:

Zip:

State: Zhejiang

Country: China

Institution: School of Ophthalmology and Optometry, Wenzhou Medical University

Telephone: 0086-577-88068879

Email: weichenmd@hotmail.com

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

Publication

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

Fungal Keratitis

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

Country: China

Timing: 2013-2014

5. Is this treatment part of a clinical trial?

Yes

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

25

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

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

No

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

Cells:

Tissues: Cornea

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?

Yes

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?

No

if yes, where?

15. Have results been published in a scientific journal?

Yes

if yes, Where?

Xenotransplantation (manuscript submitted)

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

No

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

Yes

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…)?

Unknown

if yes, which?

19. Comment

Tags:

Leave a Reply

Your email address will not be published. Required fields are marked *

*

code