Questionnaire for data collection
Person in charge of human xenotransplantation practice.
Title : MD
First Name: Sean I.
Last name : Savitz
Address :
Zip :
State : Boston (MA)
Country : USA
Institution : Harvard Meducal School
Telephone :
Email :
What is the source of your information about human xenotransplantation practices?
Publication
What is the therapeutic purpose of this xenotransplantation treatment?
Basal ganglia infarcts
Where and when is this human xenotransplantation practice taking place?
Country USA
Timing Published in 2005
Is this treatment part of a clinical trial?
Yes
How many patients are included in this clinical trial?
5
What are the inclusion criteria for patient selection?
i. Duration on the waiting list?
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? No
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 and 10 times
For how long will they continue to be taken? 2 years
For how long will they be stored?
How often is the patient seen for follow-up? 10 times
How long are the patients followed? 2 years
Location of the clinical follow-up examination:
In the same clinic?
Yes
if yes, which?
Beth Israel Deaconess 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?
Savitz S.I. et al. Neurotransplantation of fetal porcine cells in patients with basal ganglia infarcts: a preliminary safety and feasibility study. Cerebrovasc Dis. 2005; 20(2):101-7
Is this human clinical trial performed with governmental and/or institutional oversight and supervision?
Yes
if yes, which?
Federal Drug Administration
Was the trial approved by a public health authorities(ministry of health, governmental agency...)?
Yes
if yes, which?
FDA
Was the trial overseen by a public health authorities(ministry of health, governmental agency...)?
Yes
if yes, which?
Federal Drug Administration
Comment