Islets of Langerhans| Pig | China

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

Title: Professor

First Name: Wei

Last Name: Wang

Address:

Zip: 410078

State: Hunan

Country: China

Institution: Cells transplantation and gene therapy institute, The third XiangYa Hospital of Central-South University

Telephone:

Email: wawe01cn@yahoo.com.cn

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

Publication

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

Diabetes

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

Country: China

Timing: 1999-2005

5. Is this treatment part of a clinical trial?

Yes

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

22

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?

Yes

Can you give a list of microbial agents for which source animals have been tested?
Actinamycosis, candidiasis, torulosis, histolasmosis, aspergilosis, mucormycosis, bacterium bugeri, streptococus, aftosavirus, influenzaviruses, cephalitis virus, cytomegalovirus, spirochetes and swine plague
Has this microbiological testing been done by a registered laboratory?
Unknown
if yes, which?
if not, by whom?

What testing methods were used?
Unknown

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

Cells: Islets of Langerhans

Tissues:

Organs:

Others:

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

  • Solid-organ Xenotransplantation: No
  • Cellular Xenotransplantation: Yes
  • Tissue Xenotransplantation: No
  • Human cells exposed to xenogeneic Feeder cells: No
  • Extracorporeal perfusion: No
  • Encapsulation: No
  • Other bioartificial isolation device: Subcutaneous autologous collagen-covered 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?     
Cytomegalovirus, tuberculosis, hepatitis A/B/C, HIV and PERV

Has this microbiological testing been done by a registered laboratory?     
Unknown
if yes, which?
if not, by whom?

What testing methods were used?
PCR/RT-PCR
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       
How long are the patients followed?            4 - 6 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?

Journal of Central South University (Medical Sciences) 2011, 36 (12): 1134-1140

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

Yes

If yes, which?
Ethics and research committees of the Hospital Infantil de México and the Facultad de Medicina of the Nacional Autónoma de México

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

Unknown

if yes, which?

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

Unknown

if yes, which?

19. Comment

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