Main Reference

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

First Name: Bruno

Last Name: Almeida Costa

Address: Rua Cel. Nunes de Melo 1000 – Rodolfo Teófilo

Zip: 60430-275

State: Ceará

Country: Brazil

Institution: Clinical Pharmacology Unit, Drug Research and Dvelopment Center, Federal University of Ceara (UFC), Fortaleza, Ceara, Brazil

Telephone:

Email: bruno_almeida_costa@hotmail.com

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

Publication

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

Burns

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

Country: Brazil

Timing: 2016-2017

5. Is this treatment part of a clinical trial?

Yes

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

62

7. What are the inclusion criteria for patient selection?

i. Duration on the waiting list? Unknown

ii. Life-threatening diseases without alternative therapy? No

iii. Is a protocol available? Yes

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

Nile tilapia (Oreochromis niloticus)

9.Source Animals
Do you have information about source animals?

No

Source animals?

– Geographic origin? Castanhao dam fish farms

– Species?

– Strain?

– Where were the source animals kept?

– Was it a closed facility?

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

No

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

Cells:

Tissues: Skin

Organs:

Others:

12.What type of exposure to xenogeneic cells was involved?

• Solid-organ Xenotransplantation: No
• Cellular Xenotransplantation: No
• Tissue Xenotransplantation: Yes
• 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?    
Unknown

Which microbial agents have been tested in transplant recipients?     
Unknown

Has this microbiological testing been done by a registered laboratory?     
Unknown
if yes, which?
if not, by whom?

What testing methods were used?
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       Every 48h
How long are the patients followed?            Until healing of the wound, up to 23 days 
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?

J Burn Care Res (doi: 10.1093/jbcr/irz205)

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

Local institutional review board of Fortaleza

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

Yes

if yes, which?
Local institutional review board of Fortaleza

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

Unknown

if yes, which?

19. Comment

ClinicalTrial NCT03592498