Islets of Langerhans – Sertoli cells | Pig | Mexico
1. Contact address(Person who provides information. This information will be treated confidentially)?
First Name: Rafael A
Last Name: Valdés-Gonzales
Address: 4 Piso Edif.Mundet
Institution: Laboratorio de xenotransplantes, Hospital Infantil de México
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?
Timing: Approximately in 2001
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? No
iii. Is a protocol available? Yes
8. What is the animal source of the xenotransplantation product?
Do you have information about source animals?
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?
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
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
Do you have information about transplant recipients?
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?
if yes, where?
15. Have results been published in a scientific journal?
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?
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?
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…)?
if yes, which?