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The Precise Trial 6 Month Preliminary Results

The Precise Trial 6 Month Preliminary Results. Francisco F. Aviles, MD, PhD Hospital General Universitario (PI) Gregorio Marañon Madrid, Spain Emerson C. Perin, MD, PhD Texas Heart Institute (Co-PI) Houston, TX, USA. Sponsor: Cytori Therapeutics.

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The Precise Trial 6 Month Preliminary Results

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  1. The Precise Trial 6 Month Preliminary Results Francisco F. Aviles, MD, PhD Hospital General Universitario (PI) Gregorio Marañon Madrid, Spain Emerson C. Perin, MD, PhD Texas Heart Institute (Co-PI) Houston, TX, USA Sponsor: Cytori Therapeutics

  2. Study Sites and Investigators Madrid, Spain (22) Francisco Fernandez Aviles, MD, PhD Pedro Luis Sanchez, MD, PhD Ricardo Sanz, MD Rotterdam, Netherlands (3) H.J. (Eric) Duckers, MD, PhD Copenhagen, Denmark (1) Jens Kastrup, MD Utrecht, Netherlands (1) Steven Chameleau, MD, PhD

  3. Liposuction 300ml 2 hrs cell processing Treatment Group ADRCs 21 pts Control Group Placebo 6 pts 27 pts 3:1 randomization Double blind Study Design LVA/ NOGA Cell Injection/ Placebo Injection Early Assessments Core lab analysis: - Echo - SPECT - MRI - Holter - NOGA 6 Month Assessment - CCS - SPECT - NHYA - Echo - MRI - MVO2 12 Month Assessment 18 Month Assessment Long term follow up to 36 mo.

  4. Inclusion Criteria • CCS II-IV and/or NYHA II-III • LVEF  45% (Echo) • Presence of reversibility by SPECT • CAD not amenable to surgical or percutaneous revascularization • Hemodynamic stability • Ability to walk on a treadmill • Ability to undergo liposuction • Signed informed consent

  5. Exclusion Criteria • Age <20 or >75 years • Presence of Atrial Fibrillation • Presence of LV thrombus • Presence of severe valvular heart disease • Bleeding diathesis • History of malignancy in the last 5 years

  6. Exclusion Criteria • Presence of ACS or MI in the past 30 days • LV wall thickness <8 mm at the target area for cell injection • History of sudden cardiac death or sustained VT and/or VF unless (1) within 24 hrs of an acute MI; or, (2) the Subject has an AICD

  7. Targeting the Area for Stem Cell Injection Anatomical(angiogram) • Perfusion (SPECT) • Viability/ hibernation (EMM)

  8. Transendocardial Injections • Total of 15 injections • Volume of 0.2 cc • Targeted to ischemic myocardium • Injection Criteria: • Unipolar voltage 6.9mV • Loop Stability 4 • PVC upon needle insertion UniV LLS

  9. Demographics and Baseline Characteristics

  10. Safety Data Control (n=6) Treatment (n=21) Liposuction related complications 0 0 LV Mapping-induced VT 0 0 Holter: Atrial arrhythmias 0 0 Sustained VT 0 0 Pericardial Effusion 0 0 Cerebrovascular event: TIA 0 1 CVA 0 0 Angina Exacerbation 1 2 Myocardial Infarction: STEMI 0 0 NSTEMI 0 1 Heart Failure Exacerbation 0 1

  11. Safety DataDeaths Control Treatment Cardiac Deaths: < 30 d 0 0 > 30 d < 180 d 0 1 > 180 d 2 0 Non-Cardiac Deaths: < 30 d 0 0 > 30 d < 180 d 0 1 > 180 d 0 1 Total Deaths: 2 3

  12. SymptomsNYHA and CCS Class

  13. 2D Echocardiography Data6 Months

  14. LV Ejection Fraction2D Echo

  15. Magnetic Resonance Imaging6 Months LVEF Infarct Size

  16. Magnetic Resonance ImagingChange in Infarct Size at 6 Months Delayed Hyperenhancement

  17. SPECT6 Months * No statistical significant difference between groups and within each group.

  18. NOGA Injection 6 Months Unipolar Voltage (viable/scar) Linear Local Shortening (mechanical dysfunction)

  19. NOGA Injection 6 Months Unipolar Voltage (viable/scar) Linear Local Shortening (mechanical dysfunction)

  20. Metabolic Equivalents (METS)6 Months

  21. Clinical Application of VO2 Max VO2 Max reflects the degree of the impairment in: • Ventricular function (pumping capacity), • Vascular function (O2 delivery), • Skeletal muscle metabolic capacity (O2 utilization). Pts with VO2 Max ≤ 14 ml kg-1 min-1 had a 1 year survival rate of only 47%. Mancini et al, Circulation 1991

  22. Improvement in Peak VO2 is Associated with Improved Prognosis • Baseline peak VO2 of 18 ml/kg/min. • Follow-up for 17 months • Better survival in patients with improvement in MVO2. • LVEF improvement did not predict prognosis. Even in patients with moderate functional compromise MVO2 was a better prognostic marker Florea et al, Eur Heart J, 2000

  23. Peak Oxygen Consumption (VO2 Max)6 Months

  24. VO2 MaxPreliminary 18 Month Data

  25. Conclusions This is the first in man transendocardial injection of autologous adipose derived stem cells (ADRCs) in patients with chronic ischemic heart disease. Autologous ADRCs harvesting and injection was safe in these severely compromised patients. There were no peri-procedural complications and there was no evidence of cell therapy related adverse events (arrhythmia, MACCE). Improvement in functional capacity as demonstrated by METS and VO2 Max and a decrease of Infarct size as measured by MRI in ADRCs treated patients suggest potential efficacy which should be explored in a larger trial.

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