Questionnaire for data collection
Person in charge of human xenotransplantation practice.
Title : Mr.
First Name: I.E
Last name : Volkov
Address :
Zip :
State : Moscow
Country : Russia
Institution : Institute of Transplantology and Artificial Organs, Ministry of Health
Telephone :
Email :
What is the source of your information about human xenotransplantation practices?
abstract on internet: http://nikrrom.chat.ru/list1_en.htm
What is the therapeutic purpose of this xenotransplantation treatment?
Diabetes
Where and when is this human xenotransplantation practice taking place?
Country Russia
Timing Not available
Is this treatment part of a clinical trial?
Yes
How many patients are included in this clinical trial?
26children
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? No
If yes, could you please send a copy?
What is the animal source of the xenotransplantation product?
Rabbit
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: Islets of Langerhans
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? unknown
Which microbial agents have been tested in transplant recipients? unknown
Has this microbiological testing been done by a registered laboratory?
Unknwon
if yes, which?
if not, by whom?
What testing methods were used?
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? 6-12 months
Location of the clinical follow-up examination:
In the same clinic?
Yes
if yes, which?
Children Clinical Hospital
if not, where?
Have results been presented at a scientific congress?
Unknown
if yes, where?
Have results been published in a scientific journal?
Unknown
if yes, where?
Is this human clinical trial performed with governmental and/or institutional oversight and supervision?
Unknown
if yes, which?
Comment