Questionnaire for data collection
Person in charge of human xenotransplantation practice.
Title : Mr.
First Name: J.M.
Last name : Schumacher
Address :
Zip :
State : Boston (Massachusetts)
Country : USA
Institution : Lahey Medical Center
Telephone :
Email :
What is the source of your information about human xenotransplantation practices?
Publication
What is the therapeutic purpose of this xenotransplantation treatment?
Parkinson disease
Where and when is this human xenotransplantation practice taking place?
Country USA
Timing 1995
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?
ii. Life-threatening diseases without alternative therapy? Yes
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?
Species? Yorkshire pigs
Strain?
Where were the source animals kept? Isolation room
Was it a closed facility? Yes
Under what type of husbandry conditions?
a) Quarantine period Yes
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
No
if yes, which?
e) Drugs administered
No
if yes, which?
f) Vaccinations
Yes
if yes, which?
erysipela, leptospira, parvovi
g) Genetic modification of source: transgenic source animals or knock-out source animals?
No
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? serology screen included 12 pathogens
Has this microbiological testing been done by a registered laboratory?
Unknown
if yes, which?
if not, by whom?
What testing methods were used?
Enzyme-linked immunosorbent
Polymerase chain reaction
What type of cells/tissues/organs was transplanted?
Cells: Embryonic stem cells
Tissues:
Organs:
Others:
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?
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? blood samples nad monthly
For how long will they continue to be taken? one year
For how long will they be stored?
How often is the patient seen for follow-up? 12 times
How long are the patients followed? one year
Location of the clinical follow-up examination:
In the same clinic?
Yes
if yes, which?
Boston Medical Center
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?
Schumacher JM et al. Transplantation of embryonic porcine mesencephalic tissue in patients with PD. Neurology. 2000 Mar 14; 54(5):1042-50
Is this human clinical trial performed with governmental and/or institutional oversight and supervision?
Yes
if yes, which?
The Food and Drug Administration and institutional review boards of Boston Medical Center and the Lahey Medical Center
Was the trial approved by a public health authorities(ministry of health, governmental agency...)?
Yes
if yes, which?
The Food and Drug Administration and institutional review boards of Boston Medical Center and the Lahey Medical Center
Was the trial overseen by a public health authorities(ministry of health, governmental agency...)?
Unknown
if yes, which?
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