Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
SUSPENDED
Clinical Phase
PHASE2
Total Enrollment
13 participants
Study Classification
INTERVENTIONAL
Study Start Date
2007-05-31
Study Completion Date
2018-12-31
Brief Summary
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A randomized study to assess the safety, feasibility and effectiveness of direct intramyocardial percutaneous delivery of autologous bone marrow-derived total mononuclear cells or selected CD34+ cells in patients with refractory angina pectoris.
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Detailed Description
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Primary Endpoint: Incidence of major adverse cardiac events (MACE) at 30 days. MACE is defined as a combined endpoint of death, acute MI (Q-wave and non-Q wave), revascularization procedures (percutaneous or surgical), and peri-procedural complications (that is, left ventricular perforation with hemodynamic consequences requiring pericardiocentesis, and stroke).
Incidence of MACE at 3, 6 and 12 months
Secondary Endpoints:
* Change in Canadian Cardiovascular Society (CCS) angina classification score from baseline to 12 months
* Changes in the quality of life, as assessed according to the Seattle Angina Questionnaire
* Change in exercise duration and exercise tolerance using standardized treadmill exercise testing from baseline, to 6 months and to 12 months
* Cumulative number of hospitalizations for coronary ischemia and congestive heart failure at 12 months following treatment.
* SPECT-chances in global and regional radionuclide perfusion at rest, peak stress, and redistribution for baseline to 1, 6 and 12 months
* Change in angiographic collateral score at 6 months
* Change in global and regional myocardial contractility (assessed by echocardiography) at baseline, 6 and 12 months.
Incidence of MACE at 3, 6 and 12 months
Secondary Endpoints:
* Change in Canadian Cardiovascular Society (CCS) angina classification score from baseline to 12 months
* Changes in the quality of life, as assessed according to the Seattle Angina Questionnaire
* Change in exercise duration and exercise tolerance using standardized treadmill exercise testing from baseline, to 6 months and to 12 months
* Cumulative number of hospitalizations for coronary ischemia and congestive heart failure at 12 months following treatment.
* SPECT-chances in global and regional radionuclide perfusion at rest, peak stress, and redistribution for baseline to 1, 6 and 12 months
* Change in angiographic collateral score at 6 months
* Change in global and regional myocardial contractility (assessed by echocardiography) at baseline, 6 and 12 months.
Conditions
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Refractory Angina
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Mononuclear bone marrow derived cells
Intramyocardial injection of total mononuclear bone marrow derived cells
Group Type
EXPERIMENTAL
Mononuclear bone marrow derived cells
Intervention Type
PROCEDURE
Direct intramyocardial percutaneous delivery of autologous bone marrow-derived total mononuclear cells or selected CD34+ cells
Selected CD34+ bone marrow derived cells
Intramyocardial injection of selected CD34+ bone marrow derived cells
Group Type
EXPERIMENTAL
Mononuclear bone marrow derived cells
Intervention Type
PROCEDURE
Direct intramyocardial percutaneous delivery of autologous bone marrow-derived total mononuclear cells or selected CD34+ cells
Interventions
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Mononuclear bone marrow derived cells
Direct intramyocardial percutaneous delivery of autologous bone marrow-derived total mononuclear cells or selected CD34+ cells
Intervention Type
PROCEDURE
Other Intervention Names
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Selected CD34+ bone marrow derived cells
Eligibility Criteria
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Inclusion Criteria
1. Subjects \>21 years old;
2. Subjects with functional class (CCS) III or IV angina;
3. Subjects with left ventricular (LV) ejection fraction ³ 30%
4. Attempted "best" tolerated medical therapy
5. Clinical signs and symptoms of myocardial ischemia with reversible ischemia on perfusion imaging;
6. Patient deemed to be a poor candidate or at high surgical risk;
7. Subject must be able to complete a minimum of 2 minutes but no more than 10 minutes exercise test (Bruce Protocol);
8. Subject (or their legal guardian) understands the nature of the procedure and provides written consent prior to the procedure;
9. Subject is willing to comply with specified follow-up evaluations;
10. Patient must develop angina and a horizontal or down-sloping ST-segment depression of ³ 1 mm during exercise, compared to pre-exercise ST segment, 80 ms from the J point or moderate angina with or without the above ST segment changes.
1. Severe obstruction (lumen diameter stenosis \> 70%) in a coronary or surgical conduit felt to be solely or partially responsible for angina and myocardial ischemia;
2. There must be at least one coronary or surgical conduit with \< 70% diameter stenosis
3. Poor candidate for percutaneous coronary intervention of treatment zone
4. Poor candidates for surgical revascularization procedures, such as inadequate target coronary anatomy or lack of potential surgical conduits.
2. Subjects with functional class (CCS) III or IV angina;
3. Subjects with left ventricular (LV) ejection fraction ³ 30%
4. Attempted "best" tolerated medical therapy
5. Clinical signs and symptoms of myocardial ischemia with reversible ischemia on perfusion imaging;
6. Patient deemed to be a poor candidate or at high surgical risk;
7. Subject must be able to complete a minimum of 2 minutes but no more than 10 minutes exercise test (Bruce Protocol);
8. Subject (or their legal guardian) understands the nature of the procedure and provides written consent prior to the procedure;
9. Subject is willing to comply with specified follow-up evaluations;
10. Patient must develop angina and a horizontal or down-sloping ST-segment depression of ³ 1 mm during exercise, compared to pre-exercise ST segment, 80 ms from the J point or moderate angina with or without the above ST segment changes.
1. Severe obstruction (lumen diameter stenosis \> 70%) in a coronary or surgical conduit felt to be solely or partially responsible for angina and myocardial ischemia;
2. There must be at least one coronary or surgical conduit with \< 70% diameter stenosis
3. Poor candidate for percutaneous coronary intervention of treatment zone
4. Poor candidates for surgical revascularization procedures, such as inadequate target coronary anatomy or lack of potential surgical conduits.
Exclusion Criteria
1. Pregnant women;
2. Left ventricular ejection fraction \<30% as assessed by either echocardiography or left ventriculography;
3. Severe cardiac heart failure with NYHA functional class III-IV symptoms;
4. Chronic atrial fibrillation;
5. Prosthetic aortic valve;
6. Severe (grade III-IV) mitral or aortic insufficiency;
7. Wall thickness of \<8 mm (defined by echocardiography) of the proposed target region of myocardium;
8. Severe co-morbidity associated with a reduction in life expectancy of \<1 year, such as chronic medical illnesses
9. Braunwald class II unstable angina
10. Severe peripheral (or aortic) vascular disease which might increase the risk of vascular complications (perforation, dissection or embolization);
11. Significant aortic valve pathologic sclerosis or stenosis
12. LV thrombus (mobile or mural-based) seen on echocardiography;
13. Recent (within 4 weeks) documented myocardial infarction (Q and/or non-Q wave) defined as CK-MB \>3times upper normal level;
14. Currently enrolled in another investigational device or drug trial that has not completed the required follow-up period;
15. Thrombocytopenia or history of heparin-induced thrombocytopenia or thrombocytosis
16. Leukopenia
17. Leukocytosis
18. Anemia or erythrocytosis
19. Active peptic ulcer or active gastrointestinal bleeding;
20. Chronic renal failure requiring dialysis;
21. Prior or current malignancy
22. Other conditions that can significantly affect the bone-marrow
23. Evidence of concurrent infection (WBC \>12.000 mm3, temperature \>38.5° C);
24. Serological of clinical evidence of HIV
25. Immunotherapy
26. Abnormal bone-marrow morphology as evident in bone-marrow smear prior to the intervention
1. LV thrombus (mobile or mural-based) seen on left ventriculography;
2. Coronary lesions suitable for percutaneous coronary interventions;
3. Unprotected left main coronary artery disease
2. Left ventricular ejection fraction \<30% as assessed by either echocardiography or left ventriculography;
3. Severe cardiac heart failure with NYHA functional class III-IV symptoms;
4. Chronic atrial fibrillation;
5. Prosthetic aortic valve;
6. Severe (grade III-IV) mitral or aortic insufficiency;
7. Wall thickness of \<8 mm (defined by echocardiography) of the proposed target region of myocardium;
8. Severe co-morbidity associated with a reduction in life expectancy of \<1 year, such as chronic medical illnesses
9. Braunwald class II unstable angina
10. Severe peripheral (or aortic) vascular disease which might increase the risk of vascular complications (perforation, dissection or embolization);
11. Significant aortic valve pathologic sclerosis or stenosis
12. LV thrombus (mobile or mural-based) seen on echocardiography;
13. Recent (within 4 weeks) documented myocardial infarction (Q and/or non-Q wave) defined as CK-MB \>3times upper normal level;
14. Currently enrolled in another investigational device or drug trial that has not completed the required follow-up period;
15. Thrombocytopenia or history of heparin-induced thrombocytopenia or thrombocytosis
16. Leukopenia
17. Leukocytosis
18. Anemia or erythrocytosis
19. Active peptic ulcer or active gastrointestinal bleeding;
20. Chronic renal failure requiring dialysis;
21. Prior or current malignancy
22. Other conditions that can significantly affect the bone-marrow
23. Evidence of concurrent infection (WBC \>12.000 mm3, temperature \>38.5° C);
24. Serological of clinical evidence of HIV
25. Immunotherapy
26. Abnormal bone-marrow morphology as evident in bone-marrow smear prior to the intervention
1. LV thrombus (mobile or mural-based) seen on left ventriculography;
2. Coronary lesions suitable for percutaneous coronary interventions;
3. Unprotected left main coronary artery disease
Minimum Eligible Age
21 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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IRCCS San Raffaele
OTHER
Sponsor Role
lead
Responsible Party
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Antonio Colombo
Director of Invasive Cardiology Unit
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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IRCCS S. Raffaele
Milan, , Italy
Site Status
Countries
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Italy
References
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Losordo DW, Vale PR, Isner JM. Gene therapy for myocardial angiogenesis. Am Heart J. 1999 Aug;138(2 Pt 2):S132-41. doi: 10.1016/s0002-8703(99)70333-9.
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Vale PR, Losordo DW, Milliken CE, McDonald MC, Gravelin LM, Curry CM, Esakof DD, Maysky M, Symes JF, Isner JM. Randomized, single-blind, placebo-controlled pilot study of catheter-based myocardial gene transfer for therapeutic angiogenesis using left ventricular electromechanical mapping in patients with chronic myocardial ischemia. Circulation. 2001 May 1;103(17):2138-43. doi: 10.1161/01.cir.103.17.2138.
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BACKGROUND
Asahara T, Masuda H, Takahashi T, Kalka C, Pastore C, Silver M, Kearne M, Magner M, Isner JM. Bone marrow origin of endothelial progenitor cells responsible for postnatal vasculogenesis in physiological and pathological neovascularization. Circ Res. 1999 Aug 6;85(3):221-8. doi: 10.1161/01.res.85.3.221.
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Tomita S, Mickle DA, Weisel RD, Jia ZQ, Tumiati LC, Allidina Y, Liu P, Li RK. Improved heart function with myogenesis and angiogenesis after autologous porcine bone marrow stromal cell transplantation. J Thorac Cardiovasc Surg. 2002 Jun;123(6):1132-40. doi: 10.1067/mtc.2002.120716.
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Shintani S, Murohara T, Ikeda H, Ueno T, Sasaki K, Duan J, Imaizumi T. Augmentation of postnatal neovascularization with autologous bone marrow transplantation. Circulation. 2001 Feb 13;103(6):897-903. doi: 10.1161/01.cir.103.6.897.
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Fuchs S, Baffour R, Zhou YF, Shou M, Pierre A, Tio FO, Weissman NJ, Leon MB, Epstein SE, Kornowski R. Transendocardial delivery of autologous bone marrow enhances collateral perfusion and regional function in pigs with chronic experimental myocardial ischemia. J Am Coll Cardiol. 2001 May;37(6):1726-32. doi: 10.1016/s0735-1097(01)01200-1.
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Tse HF, Kwong YL, Chan JK, Lo G, Ho CL, Lau CP. Angiogenesis in ischaemic myocardium by intramyocardial autologous bone marrow mononuclear cell implantation. Lancet. 2003 Jan 4;361(9351):47-9. doi: 10.1016/S0140-6736(03)12111-3.
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Orlic D, Kajstura J, Chimenti S, Jakoniuk I, Anderson SM, Li B, Pickel J, McKay R, Nadal-Ginard B, Bodine DM, Leri A, Anversa P. Bone marrow cells regenerate infarcted myocardium. Nature. 2001 Apr 5;410(6829):701-5. doi: 10.1038/35070587.
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Kamihata H, Matsubara H, Nishiue T, Fujiyama S, Amano K, Iba O, Imada T, Iwasaka T. Improvement of collateral perfusion and regional function by implantation of peripheral blood mononuclear cells into ischemic hibernating myocardium. Arterioscler Thromb Vasc Biol. 2002 Nov 1;22(11):1804-10. doi: 10.1161/01.atv.0000039168.95670.b9.
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Kawamoto A, Tkebuchava T, Yamaguchi J, Nishimura H, Yoon YS, Milliken C, Uchida S, Masuo O, Iwaguro H, Ma H, Hanley A, Silver M, Kearney M, Losordo DW, Isner JM, Asahara T. Intramyocardial transplantation of autologous endothelial progenitor cells for therapeutic neovascularization of myocardial ischemia. Circulation. 2003 Jan 28;107(3):461-8. doi: 10.1161/01.cir.0000046450.89986.50.
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Vale PR, Losordo DW, Tkebuchava T, Chen D, Milliken CE, Isner JM. Catheter-based myocardial gene transfer utilizing nonfluoroscopic electromechanical left ventricular mapping. J Am Coll Cardiol. 1999 Jul;34(1):246-54. doi: 10.1016/s0735-1097(99)00143-6.
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Kornowski R, Hong MK, Leon MB. Comparison between left ventricular electromechanical mapping and radionuclide perfusion imaging for detection of myocardial viability. Circulation. 1998 Nov 3;98(18):1837-41. doi: 10.1161/01.cir.98.18.1837.
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Hamano K, Nishida M, Hirata K, Mikamo A, Li TS, Harada M, Miura T, Matsuzaki M, Esato K. Local implantation of autologous bone marrow cells for therapeutic angiogenesis in patients with ischemic heart disease: clinical trial and preliminary results. Jpn Circ J. 2001 Sep;65(9):845-7. doi: 10.1253/jcj.65.845.
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Reference Type
RESULT
Other Identifiers
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TVICPR-003
Identifier Type: -
Identifier Source: org_study_id
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