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1. (WO2018144099) PROCÉDÉS ET SYSTÈMES D'ÉVALUATION EN TEMPS RÉEL DE CELLULES DANS DES DISPOSITIFS D'ENCAPSULATION AVANT ET APRÈS LA TRANSPLANTATION
Note: Texte fondé sur des processus automatiques de reconnaissance optique de caractères. Seule la version PDF a une valeur juridique

WHAT IS CLAIMED IS:

1. A system for measuring oxygen consumption rate (OCR) of cells, said system comprising:

a. a bioreactor with an inlet and an outlet, wherein a first oxygen sensor is disposed at the inlet and a second oxygen sensor is disposed at the outlet;

b. an encapsulation device comprising a lumen with the cells, and a vascularizing membrane, the encapsulation device is housed in the bioreactor;

c. a heat exchanger for heating liquid media to at least one temperature from 7°C to 27°C and gas exchanger controlling oxygen levels from 0 to 100%; and

d. a pump for pumping liquid media from the heat exchanger to the bioreactor via the inlet and out the outlet;

wherein the oxygen sensors detect oxygen levels of the media for determining oxygen consumption rate of the cells.

2. The system of claim 1 further comprising a sample removal outlet for obtaining a media sample after the outlet of the bioreactor.

3. The system of claim 2, wherein the media sample is for measuring insulin secretion, glucagon, pancreatic polypeptide, c-peptide, a hormone, or a combination thereof.

4. The system of any of claims 1-3, wherein the gas exchanger provides oxygen to the media from 0 to 100%.

5. The system of claim 4, wherein oxygen production in the media can be shut off.

6. A system for measuring oxygen consumption rate (OCR) of cells, said system comprising:

a. a bioreactor with an inlet and an outlet, wherein a first oxygen sensor is disposed at the inlet and a second oxygen sensor is disposed at the outlet;

b. an encapsulation device comprising a lumen with the cells, and a vascularizing membrane, the encapsulation device is housed in the bioreactor;

c. a heat exchanger for heating liquid media to at least one temperature from 7°C to 37°C and gas exchanger controlling oxygen levels from 0 to 100%; and

d. a pump for pumping liquid media from the heat exchanger to the bioreactor via the inlet and out the outlet;

wherein the oxygen sensors detect oxygen levels of the media for determining oxygen consumption rate of the cells.

7. The system of claim 6 further comprising a sample removal outlet for obtaining a media sample after the outlet of the bioreactor.

8. The system of claim 7, wherein the media sample is for measuring insulin secretion.

9. The system of any of claims 6-8, wherein the heat exchanger provides oxygen to the media.

10. The system of claim 9, wherein oxygen production in the media can be shut off.

1 1. A system comprising:

a. a bioreactor with an inlet and an outlet, wherein a first oxygen sensor is disposed at the inlet and a second oxygen sensor is disposed at the outlet;

b. an encapsulation device comprising a lumen with the cells, and a vascularizing membrane, the encapsulation device is housed in the bioreactor;

c. a heat exchanger for heating liquid media to at least one temperature from 7°C to 37°C and gas exchanger controlling oxygen levels from 0 to 100%; and

d. a pump for pumping liquid media from the heat exchanger to the bioreactor via the inlet and out the outlet; and

e. a sample removal outlet for obtaining a media sample after the outlet of the bioreactor;

12. The system of claim 1 1 , wherein the system is for measuring oxygen consumption rate of cells, and the oxygen sensors are for detecting oxygen levels of the media.

13. The system of claim 1 1 , wherein the system is for measuring insulin secretion of cells.

14. The system of any of claims 1 1 -13, wherein the heat exchanger provides oxygen to the media.

15. The system of claim 14, wherein oxygen production in the media can be shut off.

16. The system of any of claims 1-15, wherein the cells are islet cells or stem cell- derived beta cells.

17. The system of any of claims 1 -16 further comprising a glucose sensor, a lactate sensor, a pH sensor, a C02 sensor, or a combination thereof.

18. The system of any of claims 1 -17, wherein the oxygen sensors are operatively connected to a system for regulating an amount of oxygen delivered to the cells.

19. The system of claim 18, wherein the system for regulating an amount of oxygen delivered to the cells can adjust a level of oxygen supplied to the cells based on a command received based on an oxygen level determined by the oxygen sensors.

20. A method of measuring oxygen consumption rate (OCR) of cells, said method comprising: pumping media at a temperature from 7°C to 27°C through a system comprising: a bioreactor with an inlet and an outlet, wherein a first oxygen sensor is disposed at the inlet and a second oxygen sensor is disposed at the outlet; and an encapsulation device comprising a lumen with the cells, and a vascularizing membrane, the encapsulation device is housed in the bioreactor; wherein the oxygen sensors detect oxygen levels of the media for determining oxygen consumption rate of the cells.

21. A method of measuring oxygen consumption rate (OCR) of cells, said method comprising: pumping media at a temperature from 7°C to 27°C through a system according to any of claims 1 -19; wherein the oxygen sensors detect oxygen levels of the media for determining oxygen consumption rate of the cells.

22. A method of measuring viability of cells, said method comprising: in system with an encapsulation device with cells receiving exogenous oxygen, said cells comprising islet cells or stem cell-derived beta cells, discontinuing delivery of exogenous oxygen to the cells; setting the temperature of the cells in the encapsulation device to a temperature from 7°C to 27°C; and measuring oxygen consumption rate (OCR), wherein an certain OCR level is indicative of the presence of viable cells.

23. A method of measuring viability of cells, said method comprising: in a system with an encapsulation device with cells receiving exogenous oxygen, said cells comprising islet cells or stem cell-derived beta cells, discontinuing delivery of exogenous oxygen to the cells; setting the temperature of the cells in the encapsulation device to a temperature from 7°C to 27°C; and measuring oxygen consumption rate (OCR), wherein an certain OCR level is indicative of the presence of enough viable cells for implantation of the encapsulation device.

24. The method of any of claims 20-23 further comprising raising the temperature to 37°C, and measuring glucose-stimulated insulin secretion (GSIS) of the cells.

25. The method of any of claims 20-23 further comprising raising the temperature to 37°C, and measuring glucose-stimulated insulin secretion (GSIS) of the cells, wherein an insulin secretion level within a threshold level or above a threshold level are indicative of the presence of enough viable cells for implantation of the encapsulation device.

26. The method of any of claims 22-25, wherein an oxygen sensor is disposed at both an inlet and an outlet of a bioreactor holding an encapsulation device with the cells.

27. The method of any of claims 22-26, wherein the system further comprises a glucose sensor, a lactate sensor, a pH sensor, a C02 sensor, or a combination thereof.