Questionnaire for data collection
Person in charge of human xenotransplantation practice.
Title : MD
First Name: Rafael A
Last name : Valdés-Gonzales
Address : 4 Piso Edif. Mundet
Zip : 06720
State : México
Country : Mexico
Institution : Laboratorio de xenotransplantes, Hospital Infantil de México
Telephone :
Email : rvaldes@xenomexico.org
What is the source of your information about human xenotransplantation practices?
Publication
What is the therapeutic purpose of this xenotransplantation treatment?
Diabetes
Where and when is this human xenotransplantation practice taking place?
Country Mexico
Timing Approximately in 2001
Is this treatment part of a clinical trial?
Yes
How many patients are included in this clinical trial?
12
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
If yes, could you please send a copy?
What is the animal source of the xenotransplantation product?
Pig
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 :
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
What type of cells/tissues/organs was transplanted?
Cells: Islets of Langerhans
Tissues:
Organs:
Others:
Sertoli cells
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 cell: No
Extracorporeal perfusion: No
Encapsulation: No
Other bioartificial isolation device: subcutaneous autologous collagen-covered device
Others:
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?
Unknwon
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 continue to be taken? 4 years
For how long will they be stored? 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?
Have results been presented at a scientific congress?
No
if yes, where?
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
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
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
Was the trial overseen by a public health authorities(ministry of health, governmental agency...)?
Unknown
if yes, which?
Comment