Clinical aspects for cell-based therapies for cardiac repair Pieter A. Doevendans UMC Utrecht The Netherlands Medical manager Division Heart and Lungs Representing the ESC within CAT Presented by: Name Surname CAT-DGTI-GSCN Workshop, 11 September 2014, Dresden An agency of the European Union
Efficacy of Stem cell applications? What we learned from clinical trials today! - Not clear when, what, how and how much. - Much debate on efficacy and reliability of the data reported. - No standardization of products and assessments in vitro and in vivo . 1 CAT-DGTI-GSCN Workshop, Dresden, 11 September 2014
2 CAT-DGTI-GSCN Workshop, Dresden, 11 September 2014
3 CAT-DGTI-GSCN Workshop, Dresden, 11 September 2014
Recommendations on imaging modalities in cardiac repair: Any method chosen to estimate LVEF must be used both for baseline as well as follow up Any method chosen for a trial should be the one used on all patients enrolled Change in infarct size should be evaluated by CT or MR. 256+ CT will probably be the modality of choice in the future but CMR is currently the gold standard 4 CAT-DGTI-GSCN Workshop, Dresden, 11 September 2014
5 CAT-DGTI-GSCN Workshop, Dresden, 11 September 2014
6 CAT-DGTI-GSCN Workshop, Dresden, 11 September 2014
7 CAT-DGTI-GSCN Workshop, Dresden, 11 September 2014
Infarct size 8 CAT-DGTI-GSCN Workshop, Dresden, 11 September 2014
9 CAT-DGTI-GSCN Workshop, Dresden, 11 September 2014
10 CAT-DGTI-GSCN Workshop, Dresden, 11 September 2014
Diagnosis of myocardial infarction BAMI protocol Primary Angioplasty <12 hours Days 3-5 Echocardiogram EF<45% 3000 patient outcome study End–point = 25 % reduction in death (all cause at 2 years) BM Aspiration 100mls STANDARDISATION of cell Days 5-8 Repeat processing technique Standard care Angiography BMMNC infusion 2 years Study end-point - mortality
Over 1700 pts in 33 trials 13 CAT-DGTI-GSCN Workshop, Dresden, 11 September 2014
Discrepancies vs functional outcome 14 CAT-DGTI-GSCN Workshop, Dresden, 11 September 2014
Effect vs discrepancies 15 CAT-DGTI-GSCN Workshop, Dresden, 11 September 2014
Conclusions With unselected and selected BMMNC: significant but very limited effect on Left Ventricular volumes and infarct size. Very limited effect on mortality reduction; Outcome BAMI trial? Not enough data on other cell sources yet to make firm statements. Lack of standardization: product, dosage; application mode; assessment of efficacy clinical and preclinical 16 CAT-DGTI-GSCN Workshop, Dresden, 11 September 2014
17 CAT-DGTI-GSCN Workshop, Dresden, 11 September 2014
Morphology: Infarct size MRI LGE Caduceus: cardiospheres Scipio: cardiac stem cells
Recommend Documents
Cell-based therapies for cardiac repair NON-CLINICAL ASPECTS Presented by:
Unproven cell-based therapies: a risk to public health and to the development
Quality aspects for cell-based products for cardiac repair CAT-DGTI Workshop
Clinical Development and Innovation in Engineered T Cell Therapies Bruce
Standards Coordinating Body For Cellular/Gene and Regenerative Therapies and
Regulation of cell and tissue therapies and clinical research in Australia
Reflection paper on stem cell based medicinal products - introduction
Breakthrough Stem Cell Therapies for SCI Dr. Kim Anderson-Erisman
Overview of Regulation of Stem Cell-Based Products by the U.S. FDA EMA Stem
Care of cardiac and non cardiac patients Niall Herity MD Consultant
Medical Tourism: Some Lessons for Countries that Seek Entrance to the Global
02 RJR 02 2011.qxd:Interior 4/26/11 11:57 AM Page 85 Romanian Journal of
Highlights of Cardiology Research At Genesis Nicolas W Shammas, MD, MS, FACC
2/19/2020 HEMODYNAMIC SUPPORT IN ACUTE CARDIOGENIC SHOCK Catherine T.
MEDICAL DEVICE REW a clinicians perspective INTERNATIONAL MEDICAL DEVICE
Annual Media Conference 2016 financial year Yves Serra 28.02.2017 GF
DEFUSE and DEFUSE 2 Patients with Target mismatch profile have a powerful
Do Adjuncts Improve Durability of POSE? Robert Fisher LiVES Royal Liverpool
PREGNANCY: THE KIDNEY MARATHON A training guide for women with diabetes
Hypertension Peripheral artery disease (PAD) D.L.Clement, Ghent, Belgium
Novel Evaluation With QGC001 in Hypertensive Overweight Patients of Multiple
A Leader Redefining How Kidney Disease is Treated Investor Presentation July