Questionnaire for data collection
Person in charge of human xenotransplantation practice.
Title : Mr.
First Name: Didier
Last name : Samuel
Address :
Zip :
State : Paris
Country : France
Institution : Hopital Paul Brousse
Telephone :
Email :
What is the source of your information about human xenotransplantation practices?
Publication
What is the therapeutic purpose of this xenotransplantation treatment?
Acute liver failure
Where and when is this human xenotransplantation practice taking place?
Country France
Timing Not available
Is this treatment part of a clinical trial?
No
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: Hepatocytes
Tissues:
Organs:
Others:
What type of exposure to xenogeneic cells was involved?
Solid-organ xenotransplantation: No
Cellular xenotransplantation: No
Tissue xenotransplantation: No
Human cells exposed to xenogeneic Feeder cell: No
Extracorporeal perfusion: Yes
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? peripheral blood and Peripheral blood mononuclear cells
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
Serological or culture assay testing
What samples are taken and how often? peripheral blood and Peripheral blood mononuclear cells
For how long will they continue to be taken? 6 months
For how long will they be stored? unknown
How often is the patient seen for follow-up? unknown
How long are the patients followed? 6 months
Location of the clinical follow-up examination:
In the same clinic?
Yes
if yes, which?
Hopital Paul Brousse
if not, where?
Have results been presented at a scientific congress?
Unknown
if yes, where?
Have results been published in a scientific journal?
Yes
if yes, where?
Samuel D. et al. Neurological improvement during biortificial liver sessions in patients with acute liver failure awaiting transplantation. Transplantation. 37(2):257-264, January 27, 2002
Is this human clinical trial performed with governmental and/or institutional oversight and supervision?
Yes
if yes, which?
Centre Hépatobiliaire and Site Transfusionnel
Was the trial approved by a public health authorities(ministry of health, governmental agency...)?
Yes
if yes, which?
Comité de Protection des Personnes pour la Recherche Biomédicale of Necker Hospital, Paris, and by the microbiological safety committee of the Direction des Hôpitaux.
Was the trial overseen by a public health authorities(ministry of health, governmental agency...)?
No
if yes, which?
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