Embryonic stem cells | Pig | USA

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

Title: Mr.

First Name: J.M.

Last Name: Schumacher

Zip:

State: Boston(Massachusetts)

Country: USA

Institution: Lahey Medical Center

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 disease

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

Country: USA

Timing: 1995

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?

ii. Life-threatening diseases without alternative therapy? Yes

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?

Yes

Source animals?
- Geographic origin?    
- Species?    Yorkshire Pigs
- Strain?    
- Where were the source animals kept?     Isolation room
- Was it a closed facility?    Yes

Under what type of husbandry conditions?
a) Quarantine period.   Yes
b) Presence of other animals of the same or different species.   Unknown
if yes, which?
c) Sentinel animal program.   Unknown
if yes, which?
d) Veterinary care.   No
if yes, which?
e) Drugs administered    No
if yes, which?
f) Vaccinations    Yes
if yes, which?   Erysipela, leptospira, parvovirus
g) Genetic modification of source: transgenic source animals or knock-out source animals?     No
if yes, which?
Other precautions: 

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?
Serology screen included 12 pathogens
Has this microbiological testing been done by a registered laboratory?
Unknown
if yes, which?
if not, by whom?

What testing methods were used?
Enzyme-linked immunosorbent Polymerase chain reaction

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: Yes
  • 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 nad monthly
For how long will they be store?
How often is the patient seen for follow-up       12 times
How long are the patients followed?            One Year
Location of the clinical follow-up examination?
In the same clinic?
Yes
if yes, which?
Boston 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?

Schumacher JM et al. Transplantation of embryonic porcine mesencephalic tissue in patients with PD. Neurology. 2000 Mar 14;54(5): 1042-50

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

Yes

If yes, which?
The Food and Drug Administration and institutional review boards of Boston Medical Center and the Lahey Medical Center

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

Yes

if yes, which?
The Food and Drug Administration and institutional review boards of Boston Medical Center and the Lahey Medical Center

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

Unknown

if yes, which?

19. Comment

Tags:

Leave a Reply

Your email address will not be published. Required fields are marked *

*

code