Questionnaire for data collection
Person in charge of human xenotransplantation practice.
Title : MD
First Name: J. Stephen
Last name : Fink
Address :
Zip : 02139 Cambridge
State : Massachussets
Country : USA
Institution : Genzyme Corporation
Telephone :
Email :
What is the source of your information about human xenotransplantation practices?
Publication
What is the therapeutic purpose of this xenotransplantation treatment?
Parkinson and Huntington
Where and when is this human xenotransplantation practice taking place?
Country USA
Timing Not available
Is this treatment part of a clinical trial?
Yes
How many patients are included in this clinical trial?
22
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? No
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? in accordance with Draft Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation
Has this microbiological testing been done by a registered laboratory?
Unknown
if yes, which?
if not, by whom?
What testing methods were used?
What type of cells/tissues/organs was transplanted?
Cells:
Tissues:
Organs:
Others:
Fetal ventral mesencephalic cell
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:
Others:
Transplant Do you have information about transplant recipients? Yes
How are the transplant recipients being monitored for infections? blood samples
Which microbial agents have been tested in transplant recipients? PERV
Has this microbiological testing been done by a registered laboratory?
Unknwon
if yes, which?
if not, by whom?
What testing methods were used?
PCR
What samples are taken and how often? peripheral blood mononuclear cell
For how long will they continue to be taken? 1 year
For how long will they be stored? unknown
How often is the patient seen for follow-up? 4
How long are the patients followed? 1 year
Location of the clinical follow-up examination:
In the same clinic?
Unknown
if yes, which?
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?
Fink JS et al. Cell Transplant 2000, vol 9,pp 273-278
Is this human clinical trial performed with governmental and/or institutional oversight and supervision?
Yes
if yes, which?
US Food and Drug Administration
Was the trial approved by a public health authorities(ministry of health, governmental agency...)?
Yes
if yes, which?
US Food and Drug Administration
Was the trial overseen by a public health authorities(ministry of health, governmental agency...)?
Yes
if yes, which?
US Food and Drug Administration
Comment