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