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

Title: MD

First Name: Rafael A

Last Name: Valdés-Gonzales

Address: 4 Piso Edif.Mundet

Zip: 06720

State: México

Country: México

Institution: Laboratorio de xenotransplantes, Hospital Infantil de México

Telephone:

Email: rvaldes@xenomexico.org

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: Mexico

Timing: Approximately in 2001

5. Is this treatment part of a clinical trial?

Yes

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

12

7. What are the inclusion criteria for patient selection?

i. Duration on the waiting list? Unknown

ii. Life-threatening diseases without alternative therapy? No

iii. Is a protocol available? Yes

8. What is the animal source of the xenotransplantation product?

Pig

9.Source Animals
Do you have information about source animals?

Yes

Source animals?
- Geographic origin?    New Zealand 
- Species?    Male 7-10 day old pig 
- Strain?    Unknown
- Where were the source animals kept?     Specific pathogen-free environ 
- Was it a closed facility?    Yes

Under what type of husbandry conditions?
a) Quarantine period.   Unknown
b) Presence of other animals of the same or different species.   Unknown
if yes, which?
c) Sentinel animal program.   Unknown
if yes, which?
d) Veterinary care.   Unknown
if yes, which?
e) Drugs administered    Unknown
if yes, which?
f) Vaccinations    Unknown
if yes, which?   
g) Genetic modification of source: transgenic source animals or knock-out source animals?     Unknown
if yes, which?
Other precautions: 

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?
35 organisms (20 bacteria, 4 fungi, 1 mycoplasm, 1 parasite, 9 viruse. Ref Kumar G. et al Pathology 2002 34 178-184)
Has this microbiological testing been done by a registered laboratory?
Unknown
if yes, which?
if not, by whom?

What testing methods were used?
Immunofluorescent antibody test Polymerase chain reaction

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

Cells: Islets of Langerhans

Tissues:

Organs:

Others: Sertoli cells

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?    
Peripheral blood sample

Which microbial agents have been tested in transplant recipients?     PERV, CMV, rubella, Epstein-Barr virus, toxoplasma gondii, hepa

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

What testing methods were used?
PCR
Serological or culture assay testing ELISA
What samples are taken and how often?
Quaterly
For how long will they be taken?    4 years
For how long will they be store?     Unknown
How often is the patient seen for follow-up       Quaterly for infections and daily for blood glucose 
How long are the patients followed?            4 Years
Location of the clinical follow-up examination?
In the same clinic?
Yes
if yes, which?
Hospital Infantil de México
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?

Valdes-Gonzales RA et al. Xenotransplantation of porcine neonatal islets of Langerhans and Sertoli cells: A 4-year study. Eur J Endocrinol 2005; 153: 419-427

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…)?

Yes

if yes, which?
National Transplant Center, National Bioethics Committee of the Health Ministry

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

Unknown

if yes, which?

19. Comment