Islets of Langerhans| Pig | China
1. Contact address(Person who provides information. This information will be treated confidentially)?
First Name: Wei
Last Name: Wang
Institution: Cells transplantation and gene therapy institute, The third XiangYa Hospital of Central-South 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?
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
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
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? 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?
if yes, where?
15. Have results been published in a scientific journal?
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?
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…)?
if yes, which?
18.Was the trial overseen by a public health authorities(ministry of health, governmental agency…)?
if yes, which?