Questionnaire for data collection
1. Contact address(Person who provides information. This information will be treated confidentially)?
Title :
First Name:
Last name :
Address :
Zip :
State :
Country :
Institution :
Telephone 1 :
Telephone 2 :
Email :
2. What is the source of your information about human xenotransplantation practices?
a. Publication
b. Congress
c. Advertisement
d. Others
Could you please send a copy of your source of information to our office located at University Hospital Geneva? (see Contact addresses)
3. What is the therapeutic purpose of this xenotransplantation treatment?
a. Acute liver failure :
b. Other end-stage liver diseases
c. Chronic cardiac failure :
d. Chronic renal failure :
e. Diabetes :
f. Burns :
g. Impotency :
h. Neurological degenerative disorders :
i. Others degenerative disorder :
j. Other treatments :
4. Where and when is this human xenotransplantation practice taking place?
Country
Timing
Comment
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?
ii. Life-threatening diseases without alternative therapy? Yes No
iii. Is a protocol available? Yes No
If yes, could you please send a copy of your protocol to our office located at University Hospital Geneva? (see Contact addresses)
8. What is the animal source of the xenotransplantation product?
i. Pig
ii. Non-human primate
iii. Rat
iv. Mouse
v. Others
9. Source animals Do you have information about source animals?
Source animals?
Geographic origin?
Species?
Strain?
Where were the source animals kept?
Was it a closed facility? Yes No
Under what type of husbandry conditions?
a) Quarantine period Yes No
b) Presence of other animals of the same or different species
Yes No
if yes, which?
c) Sentinel animal program
Yes No
if yes, which?
d) Veterinary care
Yes No
if yes, which?
e) Drugs administered
Yes No
if yes, which?
f) Vaccinations
Yes No
if yes, which?
g) Genetic modification of source: transgenic source animals or knock-out source animals?
Yes No
if yes, which?
Other precautions :
10. Testing of safety : Do you have information about testing of safety?
Yes No
Can you give a list of microbial agents for which source animals have been tested?
Has this microbiological testing been done by a registered laboratory?
Yes No
if yes, which?
if not, by whom?
What testing methods were used?
Complement fixation test
Enzyme-linked immunosorbent
Fluorescent antibody assay neutralization
Hemagglutination inhibition test
Immunofluorescent antibody test
Immunoperoxidase monolayer assay
Polyacrylamide gel electrophoresi
Polymerase chain reaction
Necropsy examination
Examination blood film
Microscopic agglutination test
Feacal examination
Floatation solution preparation
Feacal flotations
Feacal sedimentation
Direct smears
Scotch tape retrieval of pinworm ova
11. What type of cells/tissues/organs was transplanted?
Cells:
Hepatocytes
Islets of langerhans
Fetal islet like cell clusters
Purkinje cells
Neural precursors cells
Embryonic stem cells
Mesenchymal stem cells
Fetal sheep cells
Tissues:
Skin
Cardiac valves
Organs:
Liver
Heart
Kidney
Pancreas
Lung
Small intestine
Cornea
Others
12. What type of exposure to xenogeneic cells was involved?
Yes No
Solid-organ xenotransplantation:
Cellular xenotransplantation:
Tissue xenotransplantation:
Human cells exposed to xenogeneic Feeder cell:
Extracorporeal perfusion:
Encapsulation:
Other bioartificial isolation device:
Others:
13. Transplant recipient Do you have information about transplant recipients?
Yes No
How are the transplant recipients being monitored for infections?
Which microbial agents have been tested in transplant recipients?
Has this microbiological testing been done by a registered laboratory?
Yes No
if yes, which?
if not, by whom?
What testing methods were used?
Serological or culture assay testing
Immunohistopathology
Immunofluorescence
Radioimmunoassay
ELISA
PCR
Others :
What samples are taken and how often?
For how long will they continue to be taken?
For how long will they be stored?
How often is the patient seen for follow-up?
How long are the patients followed?
Location of the clinical follow-up examination:
In the same clinic? Yes No
if yes, which?
if not, where?
14. Have results been presented at a scientific congress?
Yes No
if yes, where?
15. Have results been published in a scientific journal?
Yes No
If yes, where? Could you please give the reference?
16. Is this human clinical trial performed with governmental and/or institutional oversight and supervision?
Yes No
if yes, which?
17. Was the trial approved by a public health authorities(ministry of health, governmental agency...)?
Yes No
if yes, which?
18.Was the trial overseen by a public health authorities(ministry of health, governmental agency...)?
Yes No
if yes, which?
19. Comment