US2009155227A1PendingUtilityA1

Combination growth factor therapy and cell therapy for treatment of acute and chronic heart disease

59
Individually held — no corporate assignee on recordPriority: Apr 6, 2000Filed: Jan 16, 2009Published: Jun 18, 2009
Est. expiryApr 6, 2020(expired)· nominal 20-yr term from priority
Inventors:Wayne P. Franco
G01N 2800/325A61K 35/28A61P 9/00A61K 38/1825G01N 33/6893G01N 2800/324A61K 38/1866G01N 2800/32
59
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Claims

Abstract

Acute and chronic heart disease is treated using a rational, multi-tier approach. A patient is pretreated with growth factor proteins or gene therapy, followed by the administration of adult stem cells. The progress of treatment is continuously monitored by echo-cardiogram with growth factor treatment and/or stem cell administration adjusted according to the results of the echo-cardiogram or clinical status of the patient. Heart disease is also treated by a method that comprises administration of a therapeutically effective amount of a growth factor protein by oral inhalation therapy.

Claims

exact text as granted — not AI-modified
1 - 36 . (canceled) 
     
     
         37 . A method for the systemic, multi-tiered treatment of acute or chronic cardiomyopathy by delivering a formulation comprising one or more therapeutic growth factor proteins together with adult stem cells, the method comprising the steps of:
 a) selecting a patient displaying symptoms of acute or chronic cardiomyopathy;   b) administering at least one dose of an effective amount of a first therapeutic growth factor protein formulation into the endocardium via a catheter comprising:
 1) a growth factor protein selected from the group consisting of FGF-1 and FGF-2, and mixtures thereof; and 
 2) a growth factor protein selected from the group consisting of VEGF, VEGF-A, VEGF-B, VEGF-165, and PIGF, and mixtures thereof; 
   c) following said administration of a first therapeutic growth factor protein formulation, administrating of at least one dose of an effective amount of adult stem cells into the endocardium via a catheter;   d) monitoring the effectiveness of administration of adult stem cells by echo-cardiogram and/or other clinical indicators;   e) determining, based on monitoring the effectiveness of stem cell treatment by echo-cardiogram and/or other clinical indicators, whether an additional dose of stem cells is indicated or whether an additional dose of growth factor protein is indicated;   f) depending on the results of the step e), administering a second dose of an effective amount of adult stem cells and/or growth factor proteins via a catheter into the endocardium; and
 if indicated, repeating steps b) through e) until there is a clinical indication of amelioration of the symptoms of acute or chronic heart disease in the patient, or until there is contraindication to continued treatment. 
   
     
     
         38 . The method of  claim 37 , wherein the symptoms of acute coronary artery disease are brought on by a condition selected from the group consisting of myocardial infarct, unstable angina, an acute anginal attack, and reperfusion injury. 
     
     
         39 . The method of  claim 38 , wherein the reperfusion injury is induced by a procedure selected from the group consisting of thrombolytic therapy, bypass surgery and angioplasty. 
     
     
         40 . The method of  claim 37 , wherein the stem cells have been isolated from the patient. 
     
     
         41 . The method of  claim 37 , wherein the stem cells have been isolated from an HLA-matched individual. 
     
     
         42 . The method of  claim 37 , wherein the stem cells are peripheral blood stem cells. 
     
     
         43 . The method of  claim 37 , wherein the stem cells are bone marrow stem cells. 
     
     
         44 . The method of  claim 37 , wherein the stem cells are purified by fluorescence-activated cell sorting. 
     
     
         45 . The method of  claim 37 , wherein the stem cells are purified by density gradient centrifugation. 
     
     
         46 . The method of  claim 37 , wherein step e) further includes monitoring the effectiveness of administration of adult stem cells by stress echo-cardiogram. 
     
     
         47 . A method for the systemic, multi-tiered treatment of acute or chronic cardiomyopathy by delivering a formulation comprising one or more therapeutic growth factor proteins together with adult stem cells, the method comprising the steps of:
 a) selecting a patient displaying symptoms of acute or chronic cardiomyopathy;   b) administering at least one dose of an effective amount of a first therapeutic growth factor protein formulation into the myocardium via a catheter comprising:
 1) a growth factor protein selected from the group consisting of FGF-1 and FGF-2, and mixtures thereof; and 
 2) a growth factor protein selected from the group consisting of VEGF, VEGF-A, VEGF-B, VEGF-165, and PIGF, and mixtures thereof; 
   c) following said administration of a first therapeutic growth factor protein formulation, administrating of at least one dose of an effective amount of adult stem cells into the myocardium via a catheter;   d) monitoring the effectiveness of administration of adult stem cells by echo-cardiogram and/or other clinical indicators;   e) determining, based on monitoring the effectiveness of stem cell treatment by echo-cardiogram and/or other clinical indicators, whether an additional dose of stem cells is indicated or whether an additional dose of growth factor protein is indicated;   f) depending on the results of the step e), administering a second dose of an effective amount of adult stem cells and/or growth factor proteins via a catheter into the myocardium; and
 if indicated, repeating steps b) through e) until there is a clinical indication of amelioration of the symptoms of acute or chronic heart disease in the patient, or until there is contraindication to continued treatment. 
   
     
     
         48 . The method of  claim 47 , wherein the symptoms of acute coronary artery disease are brought on by a condition selected from the group consisting of myocardial infarct, unstable angina, an acute anginal attack, and reperfusion injury. 
     
     
         49 . The method of  claim 48 , wherein the reperfusion injury is induced by a procedure selected from the group consisting of thrombolytic therapy, bypass surgery and angioplasty. 
     
     
         50 . The method of  claim 47 , wherein the stem cells have been isolated from the patient. 
     
     
         51 . The method of  claim 47 , wherein the stem cells have been isolated from an HLA-matched individual. 
     
     
         52 . The method of  claim 47 , wherein the stem cells are peripheral blood stem cells. 
     
     
         53 . The method of  claim 47 , wherein the stem cells are bone marrow stem cells. 
     
     
         54 . The method of  claim 47 , wherein the stem cells are purified by fluorescence-activated cell sorting. 
     
     
         55 . The method of  claim 47 , wherein the stem cells are purified by density gradient centrifugation. 
     
     
         56 . The method of  claim 47 , wherein step e) further includes monitoring the effectiveness of administration of adult stem cells by stress echo-cardiogram. 
     
     
         57 . A method for the systemic, multi-tiered treatment of acute or chronic cardiomyopathy by delivering a formulation comprising one or more therapeutic growth factor proteins together with adult stem cells, the method comprising the steps of:
 a) selecting a patient displaying symptoms of acute or chronic cardiomyopathy;   b) administering at least one dose of an effective amount of a first therapeutic growth factor protein formulation into the coronary arteries via a catheter comprising:
 1) a growth factor protein selected from the group consisting of FGF-1 and FGF-2, and mixtures thereof; and 
 2) a growth factor protein selected from the group consisting of VEGF, VEGF-A, VEGF-B, VEGF-165, and PIGF, and mixtures thereof; 
   c) following said administration of a first therapeutic growth factor protein formulation, administrating of at least one dose of an effective amount of adult stem cells into the coronary arteries via a catheter;   d) monitoring the effectiveness of administration of adult stem cells by echo-cardiogram and/or other clinical indicators;   e) determining, based on monitoring the effectiveness of stem cell treatment by echo-cardiogram and/or other clinical indicators, whether an additional dose of stem cells is indicated or whether an additional dose of growth factor protein is indicated;   f) depending on the results of the step e), administering a second dose of an effective amount of adult stem cells and/or growth factor proteins via a catheter into the coronary arteries; and
 if indicated, repeating steps b) through e) until there is a clinical indication of amelioration of the symptoms of acute or chronic heart disease in the patient, or until there is contraindication to continued treatment. 
   
     
     
         58 . The method of  claim 57 , wherein the symptoms of acute coronary artery disease are brought on by a condition selected from the group consisting of myocardial infarct, unstable angina, an acute anginal attack, and reperfusion injury. 
     
     
         59 . The method of  claim 58 , wherein the reperfusion injury is induced by a procedure selected from the group consisting of thrombolytic therapy, bypass surgery and angioplasty. 
     
     
         60 . The method of  claim 57 , wherein the stem cells have been isolated from the patient. 
     
     
         61 . The method of  claim 57 , wherein the stem cells have been isolated from an HLA-matched individual. 
     
     
         62 . The method of  claim 57 , wherein the stem cells are peripheral blood stem cells. 
     
     
         63 . The method of  claim 57 , wherein the stem cells are bone marrow stem cells. 
     
     
         64 . The method of  claim 57 , wherein the stem cells are purified by fluorescence-activated cell sorting. 
     
     
         65 . The method of  claim 57 , wherein the stem cells are purified by density gradient centrifugation. 
     
     
         66 . The method of  claim 57 , wherein step e) further includes monitoring the effectiveness of administration of adult stem cells by stress echo-cardiogram.

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