IP Library Granted Patent US 9,402,603
Granted Patent B2
US 9,402,603 · App. 13/736,132 · Granted Aug 2, 2016

Use of pulmonary surfactants in lung transplantation and methods thereof

Inventors: Federico Bianco (Parma, IT); Roberta Razzetti (Parma, IT); Patrizio Vitulo (Parma, IT); Alessandro Bertani (Parma, IT)
Assignee: CHIESI FARMACEUTICI S.p.A.
A61B17/00A61B16/00A61B5/413A61B2017/00969A61K38/00
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Quick Facts
Patent No.
US 9,402,603
App. No.
13/736,132
Granted
Aug 2, 2016
Kind
B2
Abstract

The present invention concerns a method of treating an advanced lung disease in a patient in need thereof by lung transplantation.

Claims (36)

1. A method of treating an advanced lung disease selected from the group consisting of advanced chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), cystic fibrosis (CF), emphysema due to alpha-1 antitrypsin deficiency, and idiopathic pulmonary arterial hypertension (IPAH) in a patient in need thereof by lung transplantation, said method comprising:

(i) withdrawing a lung with trachea to be implanted from a donor and dissecting it on a backtable;

(ii) administering a therapeutically effective amount of an aqueous suspension of pulmonary surfactant poractant alfa having a concentration of 80 mg/ml based on the total volume of said aqueous suspension directly into the trachea on said back table after withdrawal of said lung;

(iii) preserving said lung until implantation; and

(iv) transplanting said lung into said patient,

wherein said preserving said lung (iii) is carried out by applying a hypothermic (cold) static lung preservation technique.

2. A method according to claim 1 , wherein said cold preservation technique is performed at a temperature of 4° C.

3. A method according to claim 1 , wherein said poractant alfa is administered in an amount of 10 to 200 mg/kg of body weight of said donor.

4. A method according to claim 1 , wherein said poractant alfa is administered in an amount of 25 to 80 mg/kg of body weight of said donor.

5. A method according to claim 1 , wherein said poractant alfa is administered in an amount of 30 mg/kg of body weight of said donor.

6. A method according to claim 1 , wherein said poractant alfa is administered into the trachea with a bronchoscope.

7. A method according to claim 1 , wherein said poractant alfa is administered into the trachea without a bronchoscope.

8. A method according to claim 1 , wherein said advanced lung disease is advanced chronic obstructive pulmonary disease (COPD).

9. A method according to claim 1 , wherein said advanced lung disease is idiopathic pulmonary fibrosis (IPF).

10. A method according to claim 1 , wherein said advanced lung disease is cystic fibrosis (CF).

11. A method according to claim 1 , wherein said advanced lung disease is emphysema due to alpha-1 antitrypsin deficiency.

12. A method according to claim 1 , wherein said advanced lung disease is idiopathic pulmonary arterial hypertension (IPAH).

13. A method according to claim 1 , wherein said cold preservation technique is performed at a temperature of 4° C. or 10° C.

14. A method of treating an advanced lung disease selected from the group consisting of advanced chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), cystic fibrosis (CF), emphysema due to alpha-1 antitrypsin deficiency, and idiopathic pulmonary arterial hypertension (IPAH) in a patient in need thereof by lung transplantation, said method comprising:

(i) withdrawing a lung with trachea to be implanted from a donor and dissecting it on a backtable;

(ii) administering a therapeutically effective amount of an aqueous suspension of pulmonary surfactant poractant alfa having a concentration of 80 mg/ml based on the total volume of said aqueous suspension directly into the trachea on said back table after withdrawal of said lung;

(iii) preserving said lung until implantation; and

(iv) transplanting said lung into said patient,

wherein said preserving said lung (iii) is carried out by applying a hypothermic (cold) static lung preservation technique without continuous perfusion and ventilation.

15. A method according to claim 14 , wherein said cold preservation technique is performed at a temperature of 4° C.

16. A method according to claim 14 , wherein said poractant alfa is administered in an amount of 10 to 200 mg/kg of body weight of said donor.

17. A method according to claim 14 , wherein said poractant alfa is administered in an amount of 25 to 80 mg/kg of body weight of said donor.

18. A method according to claim 14 , wherein said poractant alfa is administered in an amount of 30 mg/kg of body weight of said donor.

19. A method according to claim 14 , wherein said poractant alfa is administered into the trachea with a bronchoscope.

20. A method according to claim 14 , wherein said poractant alfa is administered into the trachea without a bronchoscope.

21. A method according to claim 14 , wherein said advanced lung disease is advanced chronic obstructive pulmonary disease (COPD).

22. A method according to claim 14 , wherein said advanced lung disease is idiopathic pulmonary fibrosis (IPF).

23. A method according to claim 14 , wherein said advanced lung disease is cystic fibrosis (CF).

24. A method according to claim 14 , wherein said advanced lung disease is emphysema due to alpha-1 antitrypsin deficiency.

25. A method according to claim 14 , wherein said advanced lung disease is idiopathic pulmonary arterial hypertension (IPAH).

26. A method according to claim 14 , wherein said cold preservation technique is performed at a temperature of 4° C. or 10° C.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 2, 2014
From: BIANCO, FEDERICO; RAZZETTI, ROBERTA; VITULO, PATRIZIO; BERTANI, ALESSANDRO
To: CHIESI FARMACEUTICI S.P.A.
Reel/Frame 031878/0739 →
Continuity (2)
Provisional Application 61722984 · Nov 6, 2012
Related Publication 20140128846A1 · May 8, 2014