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

Title: Professor

First Name: Patrick

Last Name: Aebischer

State: Lausanne

Country: Switzerland

Institution: Gene Therapy Center and Division of Surgical Research, CHUV

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

Publication

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

Amyotrophic lateral sclerosis

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

Country: Switzerland

Timing: 2000

5. Is this treatment part of a clinical trial?

Yes

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

12

7. What are the inclusion criteria for patient selection?

i. Duration on the waiting list? Unknown

ii. Life-threatening diseases without alternative therapy? Yes

iii. Is a protocol available? Yes

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

Hamster

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:

Tissues:

Organs:

Others: Kidney cells

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: Yes
• Other bioartificial isolation device:
• Others:

13. Do you have information about transplant recipients?

No

14. Have results been published in a scientific journal?

Unknown

if yes, where?

15. Have results been published in a scientific journal?

Yes

If yes, Where?

Zurn AD et al., Evaluation of an intrathecal immune response in amyotrophic lateral sclerosis patients implanted with encapsulated genetically engineered xenogeneic cells. Cell Transplant 2000 Jul-Aug;9(4):471-84

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

Unknown

If yes, which?

17. Comment

They used genetically engineered baby hamster kidney(BHK) cells releasing human ciliary neurotrophic factor