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

Title: MD

First Name: Sean I.

Last Name: Savitz

Zip:

State: Boston(Massachusetts)

Country: USA

Institution: Harvard Medical School

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?

Basal ganglia infarcts

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

Country: USA

Timing: Published in 2005

5. Is this treatment part of a clinical trial?

Yes

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

5

7. 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

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?

No

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

Cells: Embryonic stem cells

Tissues:

Organs:

Others:

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. 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?     
Unknown
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 be store?    2 years
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?

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?

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

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

Yes

If yes, which?
Federal Drug Administration

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

Yes

if yes, which?
FDA

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

Yes

if yes, which?
Federal Drug Administration

19. Comment