Questionnaire for data collection
Person in charge of human xenotransplantation practice.
Title : Professor.
First Name: Robert Bartlett
Last name : Elliott
Address : PO Box 23566 Hunters Corner
Zip : 2155
State : Manukau, Auckland
Country : New Zealand
Institution : Living Cell Technologies
Telephone : +61 3 9813 5501
Email : info@lctglobal.com
What is the source of your information about human xenotransplantation practices?
Congress
What is the therapeutic purpose of this xenotransplantation treatment?
Diabetes
Where and when is this human xenotransplantation practice taking place?
Country New zealand
Timing Not available
Is this treatment part of a clinical trial?
Yes
How many patients are included in this clinical trial?
14 patient
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?
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: 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: Yes
Other bioartificial isolation device:
Others:
Transplant Do you have information about transplant recipients? Yes
How are the transplant recipients being monitored for infections? blood plasma and peripheral blood marrow 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
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? 9 years
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?
Yes
if yes, where?
10th Congress of the International Pancreas and Islet Transplantation Association in Geneva 2005. Elliot RB et al. Long term survival of alginate encapsulated piglet islets in a patient with type 1 diabetes (abstract OP-056)
Have results been published in a scientific journal?
Yes
if yes, where?
Elliott RB et al. No evidence of infection with porcine andogenous retrovirus in recipients of encapsulated porcineislet xenografts. Cell Transplant 2000;9:895-901
Is this human clinical trial performed with governmental and/or institutional oversight and supervision?
Unknown
if yes, which?
Comment

Living Cell Technologies have two office: one in australia and the other in New Zealand