Main Reference

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

Title: MD

First Name: Shinichi

Last Name: Matsumoto

Address: 115 Kuguhara, Tateiwa, Muya-cho, Naruto, Tokushima

Zip: 772-8601

State: Tokushima

Country: Japan

Institution: Otsuka Pharmaceutical Factory, Inc.

Telephone:

Email: matsumoto.shinichi@otsuka.jp

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

Publication

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

Diabetes

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

Country: Argentina

Timing: 2011-2012

5. Is this treatment part of a clinical trial?

Yes

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

8

7. What are the inclusion criteria for patient selection?

i. Duration on the waiting list? Unknown

ii. Life-threatening diseases without alternative therapy? Unknown

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? Auckland Island Pig

– Strain?

– Where were the source animals kept? Pathogen-free facility

– Was it a closed facility? Yes

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

10. Testing of safety
Do you have information about testing of safety?

No

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

Cells: Islet of Langerhans

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?

No

How are the transplant recipients being monitored for infections?    
Unknown

Which microbial agents have been tested in transplant recipients?     
PERV (provirus, genomic RNA and antibodies)

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?
For how long will they be taken?    
For how long will they be store?     
How often is the patient seen for follow-up       Weeks 1, 4, 12, 24, 52 and 104
How long are the patients followed?            2 year
Location of the clinical follow-up examination?  
In the same clinic?
if yes, which?
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?

EBioMedicine 12 (2016) 255–262,doi: 10.1016/j.ebiom.2016.08.034.

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

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

Ministry of Health of Buenos Aires Province

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

if yes, which?

19. Comment

ClinicalTrial NCT01739829