1. Contact address(Person who provides information. This information will be treated confidentially)?

Title: MD

First Name: J. Stephen

Last Name: Fink

Zip: 02139 Cambridge

State: Massachussets

Country: USA

Institution: Genzyme Corporation

Telephone:

Email:

2. What is the source of your information about human xenotransplantation practices?

Publication

3. What is the therapeutic purpose of this xenotransplantation treatment?

Parkinson and Huntington

4. Where and when is this human xenotransplantation practice taking place?

Country: USA

Timing: Not available

5. Is this treatment part of a clinical trial?

Yes

6. How many patients are included in this clinical trial?

22

7. 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? Yes

8. What is the animal source of the xenotransplantation product?

Pig

9.Source Animals

Do you have information about source animals?

No

10. 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?

In accordance with Draft Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation

Has this microbiological testing been done by a registered laboratory?

if yes, which?

if not, by whom?

what testing methods were used?

11. What type of cells/tissues/organs was transplanted?

Cells:

Tissues:

Organs:

Others: Fetal ventral / Mesencephalic / cell

12.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 cells: No
• Extracorporeal perfusion: No
• Encapsulation: No
• Other bioartificial isolation device:
• Others:

13. Do you have information about transplant recipients?

Yes

• How are the transplant recipients being monitored for infections? Blood Samples
• Which microbial agents have been tested in transplant recipients? PERV
• Has this microbiological testing been done by a registered laboratory? Unknown
• What testing methods were used? PCR
• What samples are taken and how often? peripheral blood mononuclear cell
• For how long will they continue to be taken? 1 year
• For how long will they be stored? Unknown
• How often is the patient seen for follow-up? 4
• How long are the patients followed? 1 year
• Location of the clinical follow-up examination: In the same clinic? Unknown

14. Have results been presented at a scientific congress?

No

if yes, where?

15. Have results been published in a scientific journal?

Yes

if yes, Where?

Fink JS et al. Cell Transplant 2000, vol 9, pp 273-278

16. Is this human clinical trial performed with governmental and/or institutional oversight and supervision?

Yes

If yes, which?

US Food and Drug Administration

17. Was the trial approved by a public health authorities(ministry of health, governmental agency…)?

Yes

if yes, which?

US Food and Drug Administration

18.Was the trial overseen by a public health authorities(ministry of health, governmental agency…)?

Yes

if yes, which?

US Food and Drug Administration

19. Comment