c-kit Stem Cell Therapy of Ischemic Cardiomyopathy

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1 American Heart Association Scientific Sessions American Heart Association Scientific Sessions c-kit Stem Cell Therapy of Ischemic Cardiomyopathy Roberto Bolli, M.D. Institute of Molecular Cardiology University of Louisville Los Angeles, CA

2 Presenter Disclosure information Roberto Bolli, M.D. c-kit Stem Cell Therapy of Ischemic Cardiomyopathy FINANCIAL DISCLOSURE: None UNLABELED/UNAPPROVED USES DISCLOSURE: None

3 Publius Cornelius Scipio Africanus ( BC) SCIPIO (Study of Cardiac Stem Cells Infusion in Patients with Ischemic CardiOmyopathy) Phase I, open-label, randomized trial Single center 20 treated and 13 control patients

4 SCIPIO (Study of Cardiac Stem Cells Infusion in Patients with Ischemic CardiOmyopathy) Institute of Molecular Cardiology Brigham and Women s Hospital John Loughran Brandon Elmore Marcus Stoddard Garth Beache Atul Chugh Sohail Ikram Steve Wagner Piero Anversa Annarosa Leri Jan Kajstura Domenico D Amario

5 SCIPIO: Objectives The overall goal is to translate the discovery of CSCs into clinically useful therapies. Primary Objective 1. To assess the feasibility and safety of infusing autologous c-kit pos CSCs in patients with ischemic heart failure. Secondary Objective 2. To obtain preliminary evidence for or against the efficacy of CSCs in augmenting LV function, improving functional status, and promoting myocardial regeneration.

6 SCIPIO: Time Line A result of many years of preclinical work: FDA contacted in October 2004 FDA approval on August 8, 2008 First patient enrolled on March 13, 2009 Last Patient Enrolled May 17, IND application submitted on January 2006 Trial opened to enrollment in February 2009 First CSC infusion July 17, 2009

7 November 14, 2011

8 SCIPIO Inclusion Criteria LVEF 40% A history of Q-wave MI with a residual scar (as evidenced by ECG, cardiac MRI, low-dose dobutamine stress echo, and/or rest perfusion images on a sestamibi SPECT study) Patient scheduled for CABG within 2 weeks of the initial screening.

9 SCIPIO: Protocol < 2 Weeks Enrollment CABG & Tissue Harvesting At the time of CABG, the right atrial appendage is resected and prepared for CSC isolation CSC isolation and expansion

10 SCIPIO: Protocol < 2 Weeks 4 ± 1 Months 2 Years Enrollment CABG & Tissue Harvesting CSC Infusion Follow-Up Cardiac MRI 2-D & 3-D Echo ECG, Physical Exam BMP, LFTs, CBC, and BNP Minnesota Heart Questionnaire and NYHA class assessment

11 SCIPIO: Protocol 2-D & 3-D Echo 24-h Holter monitor ECG BMP & LFTs CBC, & cardiac enzymes Physical Exam 2-D & 3-D Echo Cardiac MRI ECG, Physical Exam BMP, LFTs, CBC, and BNP Minnesota Heart Questionnaire and NYHA class assessment CSC Rx Follow-up 24h Week 1 Week 2 Week 4 Month 4 ECG x 3 BMP, LFTs CBC Cardiac enzymes x 3 Physical exam ECG BMP, LFTs CBC Cardiac enzymes Physical exam 2-D & 3-D Echo 24-h Holter monitor ECG BMP & LFTs CBC, & cardiac enzymes Physical Exam

12 SCIPIO: Protocol 2-D & 3-D Echo Cardiac MRI ECG, Physical Exam BMP, LFTs, CBC, and BNP Minnesota Heart Questionnaire and NYHA class assessment CSC Rx Follow-up Month 8 Year 1 Year 2 ECG BMP, LFTs CBC 2-D & 3-D Echo Cardiac MRI ECG, Physical Exam BMP, LFTs, CBC, and BNP Minnesota Heart Questionnaire and NYHA class assessment

13 SCIPIO Phenotype of CSCs

14 SCIPIO: Phenotype of CSCs

15 SCIPIO: Phenotype of CSCs

16 SCIPIO Phenotype of CSCs

17 SCIPIO: Phenotype of CSCs

18 SCIPIO: Phenotype of CSCs

19 SCIPIO: Phenotype of CSCs

20 SCIPIO: Phenotype of CSCs Telomere Length

21 Absolute EF Units SCIPIO: Results Ejection Fraction at 4 Months After CSCs 60 P= ± ± ± ± Baseline 4 months Controls (n=7) Pre-CSC 4 months CSC-treated (n=14)

22 Absolute EF Units SCIPIO: Results Change in Ejection Fraction After CSC Treatment n=14 n= P= ±2.0 P< ± months 12 months

23 Absolute EF units SCIPIO: MRI Results Ejection Fraction (MRI) After CSC Therapy n=8 n=8 n=5 Pre-CSC P=0.004 P= months 12 months 41.2

24 ΔEF (absolute EF units) SCIPIO: MRI Results Change in Ejection Fraction (MRI) After CSC Therapy 25 n=8 n=5 Baseline EF: 27.5% 20 P= ± P= ± months 12 months

25 Absolute EF units ΔEF (absolute EF units) SCIPIO: MRI Results Regional Ejection Fraction in Infarct-Related Segments After CSC Therapy 80 n=8 n=8 n=5 40 n=8 n= P= ±3.9 P= ± Pre-CSC 4 months 12 months 4 months 12 months

26 Absolute EF units SCIPIO: MRI Results Regional Ejection Fraction (MRI) in Infarct- Related Segments After CSC Therapy 40 P=0.008 n=8 50 P=0.085 n= ± ± ± ± Pre-CSC 4 months Pre-CSC 12 months

27 Absolute EF units ΔEF (absolute EF units) SCIPIO: MRI Results Regional Ejection Fraction in Dyskinetic Segments After CSC Therapy 40 n=7 n=7 n=4 80 n=7 n= P= ±7.1 P= ± Pre-CSC 4 months 12 months 4 months 12 months

28 Absolute EF units ΔEF (absolute EF units) SCIPIO: MRI Results Regional Ejection Fraction in the Least Functional Segment After CSC Therapy n=8 n=8 n= n=8 P= ±8.5 n=5 P= ± Pre-CSC 4 months 12 months 0 4 months 12 months

29 SCIPIO: Results Global Wall Motion Score Index 4 Months After CSC Treatment 3.0 P= Baseline 4 months Controls (n=7) Pre-CSC 4 months CSC-treated (n=14)

30 SCIPIO: Results Global WMSI After CSC Treatment in Patients Who Have Completed 12 Month Follow-up 5 n=8 4 P= ±0.08 P= ± ± Pre-CSC 4 months 12 months

31 SCIPIO: Infarct Regression Before CSCs 24 months after CSCs

32 Mass (g) Change in mass (g) SCIPIO: MRI Results Change in Infarct Size by CMR Using a Semiautomated (FWHM) Method After CSC Treatment 50 n=9 n=9 n= Pre-CSC months 12 months P< ± % n=9 P= ± % n=6 4 months 12 months

33 Mass (g) Change in mass (g) SCIPIO: MRI Results Change in Non-Viable Tissue by CMR After CSC Treatment n=9 n=9 n= Pre-CSC months 12 months ±2.5 P= % -14.8±3.9 P= % n=9 n=6 4 months 12 months

34 Mass (g) Change in mass (g) SCIPIO: MRI Results Change in Viable Tissue by CMR After CSC Treatment n=9 n=9 n= n=9 n=6 7.6% 11.6±5.2 P= % 31.5±11.0 P= Pre-CSC 4 months 12 months 0 4 months 12 months

35 SCIPIO: Results 4 New York Heart Association Score 4 Months After CSC Treatment 3 P=0.172 P= ± ± ± ± Baseline 4 months Controls (n=7) Pre-CSC 4 months CSC-treated (n=16)

36 SCIPIO: Results NYHA Score After CSC Treatment in Patients Who Have Completed 12 Month Follow-up 6 5 P=0.004 n=10 4 P= ± ± ± Pre-CSC 4 months 12 months

37 SCIPIO: Results MLHFQ Score 4 Months After CSC Treatment ± ± ±5.2 P< ± Baseline 4 months Pre-CSC 4 months Controls (n=7) CSC-treated (n=16)

38 SCIPIO: Results MLHFQ After CSC Treatment in Patients Who Have Completed 12 Month Follow-up ±7.5 P<0.001 P=0.007 n= ± ± Pre-CSC 4 months 12 months

39 SCIPIO: Summary i) Feasibility and safety The initial results of SCIPIO indicate that, in patients with ischemic cardiomyopathy: 1. Isolation, expansion, and infusion of a highly pure population of c-kit pos CSCs are feasible in virtually all cases. 2. It is possible to obtain viable CSCs with high telomerase activity and telomeres >7 kbp. 3. Intracoronary infusion of autologous CSCs is not associated with appreciable adverse effects.

40 SCIPIO: Summary ii) Efficacy The initial results of SCIPIO indicate that: 4. Infusion of CSCs results, 4 months later, in a reduction in infarct size, an increase in viable myocardium, and a marked improvement in LV EF, NYHA functional class, and quality of life (MLHFQ). 5. These effects persist and are even more pronounced at 1 year.

41 SCIPIO: Conclusions The initial results of SCIPIO suggest that administration of autologous c-kit pos CSCs is feasible and safe and produces a sustained increase in viable myocardium, LV systolic function, and functional capacity in patients with ischemic cardiomyopathy. Larger, Phase II studies are warranted.

42 Acknowledgments Xian-Liang Tang Yiru Guo Gregg Rokosh Qianghong Li Institute of Molecular Cardiology Atul Chugh John Loughran Sohail Ikram Marcus Stoddard Steve Wagner Garth Beache Mark Slaughter Boston group Piero Anversa Annarosa Leri Jan Kajstura

43 Thank You

Domenico D Amario MD, PhD Università Cattolica del Sacro Cuore Rome:

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