Table Of Content

Stem Cell Surgery Trials in Heart Failure and Diabetes A Concise Guide Jeff rey N. Weiss 123 Stem Cell Surgery Trials in Heart Failure and Diabetes Jeffrey N. Weiss Author Stem Cell Surgery Trials in Heart Failure and Diabetes A Concise Guide Jeffrey N. Weiss Parkland, FL, USA ISBN 978-3-030-78009-8 ISBN 978-3-030-78010-4 (eBook) https://doi.org/10.1007/978-3-030-78010-4 © The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2022 This work is subject to copyright. All rights are solely and exclusively licensed by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, expressed or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. This Springer imprint is published by the registered company Springer Nature Switzerland AG The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland Preface Parts I–IV of this book identify and summarize the current worldwide stem cell tri- als for heart failure. Only studies using non-expanded stem cells and not being used in conjunction with a proprietary or non-proprietary treatment are included. All studies are Institutional Review Board (IRB) approved and registered with clinical- trials.gov. The studies are grouped by the type of stem cells utilized and divided between US and non-US studies. Only “recruiting”; “not yet recruiting”; “active, not recruit- ing”; and “enrolling by invitation” studies are included. Studies that were listed as “suspended,” “terminated,” “completed,” “withdrawn,” or “unknown status” were not included. Each submission was individually reviewed, and errors were corrected. Parts V–XV identify and summarize the current worldwide stem cell trials in patients with diabetes mellitus. All studies are Institutional Review Board (IRB) approved and registered with clinicaltrials.gov. The studies are grouped by the type 1 or type 2 diabetes diagnosis and the geo- graphic location of the study. Only “recruiting”; “not yet recruiting”; “active, not recruiting”; and “enrolling by invitation” studies are included. Studies that were listed as “suspended,” “terminated,” “completed,” “withdrawn,” or “unknown sta- tus” were not included. Each submission was individually reviewed, only pertinent studies were included, and errors were corrected. Having a listing and description of studies pertaining to the use of stem cells in the treatment of heart failure and in diabetes provides the physician with a handy knowledge of IRB-approved studies in these fields. Parkland, FL, USA Jeffrey N. Weiss v Contents Part I Heart Failure (United States) 1 Bone Marrow-Derived Mesenchymal Stem Cells in Improving Heart Function in Patients with Heart Failure Caused by Anthracyclines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 2 Donor Bone Marrow-Derived Mesenchymal Stem Cells in Controlling Heart Failure in Patients with Cardiomyopathy Caused by Anthracyclines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 3 The Transendocardial Autologous Cells (hMSC) or (hMSC) and (hCSC) in Ischemic Heart Failure Trial . . . . . . . . . . . . . . . . . . . . 13 4 Regression of Fibrosis and Reversal of Diastolic Dysfunction in HFPEF Patients Treated with Allogeneic CDCs . . . . . . . . . . . . . . . 21 5 Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure . . . . . . . 25 Part II H eart Failure (Europe) 6 Allogeneic Stem Cell Therapy in Heart Failure . . . . . . . . . . . . . . . . . . 33 7 Stem Cell Therapy in Advanced Heart Failure . . . . . . . . . . . . . . . . . . 37 8 Stem Cell Therapy in Ischemic Non- treatable Cardiac Disease . . . . . 39 9 Infusion Intracoronary of Mononuclear Autologous Adult Non Expanded Stem Cells of Bone Marrow on Functional Recovery in Patients with Idiopathic Dilated Cardiomyopathy and Heart Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 vii viii Contents 10 Cell Therapy in HFpEF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 11 Compare the Effects of Single Versus Repeated Intracoronary Application of Autologous Bone Marrow-Derived Mononuclear Cells on Mortality in Patients with Chronic Post-infarction Heart Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 12 Impact of Intracoronary Injection of Autologous BMMC for LV Contractility and Remodeling in Patients with STEMI . . . . . 55 13 Stem Cell Therapy in Non-ischemic, Non- treatable Dilated Cardiomyopathies II: A Pilot Study . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Part III H eart Failure (Iran) 14 IMMNC-HF: IntraMyocardial Injection of Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients . . . . . . . . . . . . . . . 67 15 ICMNC-HF: IntraCoronary Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71 Part IV H eart Failure (China) 16 Treating Heart Failure with hPSC-CMs . . . . . . . . . . . . . . . . . . . . . . . . 77 Part V Diabetes Mellitus: Type 1 Diabetes (United States) 17 Cellular Therapy for Type 1 Diabetes Using Mesenchymal Stem Cells . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85 18 A Pilot Study of the Therapeutic Potential of Stem Cell Educator Therapy in Type 1 Diabetes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 19 Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 20 Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease . . . 97 Part VI D iabetes Mellitus: Type 1 Diabetes (China) 21 Stem Cell Educator Therapy in Diabetes . . . . . . . . . . . . . . . . . . . . . . . 103 22 Reversal of Type 1 Diabetes in Children by Stem Cell Educator Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107 Part VII Diabetes Mellitus: Type 1 Diabetes (China/Spain) 23 Stem Cell Educator Therapy in Type 1 Diabetes . . . . . . . . . . . . . . . . . 113 Contents ix Part VIII Diabetes Mellitus: Type 1 Diabetes (South America) 24 Mesenchymal Stem Cells in Patients with Type 1 Diabetes Mellitus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119 Part IX D iabetes Mellitus: Type 1 Diabetes (Canada) 25 Stem Cell Mobilization (Plerixafor) and Immunologic Reset in Type 1 Diabetes (T1DM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125 Part X Diabetes Mellitus: Type 1 Diabetes (Middle East) 26 Mesenchymal Stem Cell Transplantation in Newly Diagnosed Type 1 Diabetes Patients (MSCTXT1DM) . . . . . . . . . . . . . . . . . . . . . . 133 27 Use of Stem Cells in Diabetes Mellitus Type 1 . . . . . . . . . . . . . . . . . . . 139 Part XI D iabetes Mellitus: Type 1 Diabetes (Sweden) 28 Wharton’s Jelly-Derived Mesenchymal Stromal Cell-Repeated Treatment of Adult Patients Diagnosed with Type I Diabetes . . . . . . 145 Part XII Diabetes Mellitus: Type 2 Diabetes (United States) 29 Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial Dysfunction in Diabetic Subjects (ACESO) . . . . . . . . 151 30 Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease . . . 157 Part XIII Diabetes Mellitus: Type 2 Diabetes (China) 31 Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cell Transplantation in Patients with Type 2 Diabetes Mellitus . . . . . . . . 163 32 Stem Cell Educator Therapy in Diabetes . . . . . . . . . . . . . . . . . . . . . . . 167 33 Clinical Study of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Type 2 Diabetic Nephropathy . . . . . . . . . . . . . . . . 171 Part XIV Diabetes Mellitus: Type 2 Diabetes (Near East) 34 BM-MNC and UCMSC for Type 2 Diabetes Mellitus Patients . . . . . 175 Part XV Diabetes Mellitus: Type 2 Diabetes (Vietnam) 35 BM-MNC and UC-MSC Infusion for Type 2 Diabetes Mellitus Patients (T2DM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181 x Contents Part XVI Other Thoughts 36 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188 Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191 Part I Heart Failure (United States)

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by  Jeffrey N. Weiss
#Medicine #Diabetes
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Stem Cell Surgery Trials in Heart Failure and Diabetes A Concise Guide Jeff rey N. Weiss 123 Stem Cell Surgery Trials in Heart Failure and Diabetes Jeffrey N. Weiss Author Stem Cell Surgery Trials in Heart Failure and Diabetes A Concise Guide Jeffrey N. Weiss Parkland, FL, USA ISBN 978-3-030-78009-8 ISBN 978-3-030-78010-4 (eBook) https://doi.org/10.1007/978-3-030-78010-4 © The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2022 This work is subject to copyright. All rights are solely and exclusively licensed by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, expressed or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. This Springer imprint is published by the registered company Springer Nature Switzerland AG The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland Preface Parts I–IV of this book identify and summarize the current worldwide stem cell tri- als for heart failure. Only studies using non-expanded stem cells and not being used in conjunction with a proprietary or non-proprietary treatment are included. All studies are Institutional Review Board (IRB) approved and registered with clinical- trials.gov. The studies are grouped by the type of stem cells utilized and divided between US and non-US studies. Only “recruiting”; “not yet recruiting”; “active, not recruit- ing”; and “enrolling by invitation” studies are included. Studies that were listed as “suspended,” “terminated,” “completed,” “withdrawn,” or “unknown status” were not included. Each submission was individually reviewed, and errors were corrected. Parts V–XV identify and summarize the current worldwide stem cell trials in patients with diabetes mellitus. All studies are Institutional Review Board (IRB) approved and registered with clinicaltrials.gov. The studies are grouped by the type 1 or type 2 diabetes diagnosis and the geo- graphic location of the study. Only “recruiting”; “not yet recruiting”; “active, not recruiting”; and “enrolling by invitation” studies are included. Studies that were listed as “suspended,” “terminated,” “completed,” “withdrawn,” or “unknown sta- tus” were not included. Each submission was individually reviewed, only pertinent studies were included, and errors were corrected. Having a listing and description of studies pertaining to the use of stem cells in the treatment of heart failure and in diabetes provides the physician with a handy knowledge of IRB-approved studies in these fields. Parkland, FL, USA Jeffrey N. Weiss v Contents Part I Heart Failure (United States) 1 Bone Marrow-Derived Mesenchymal Stem Cells in Improving Heart Function in Patients with Heart Failure Caused by Anthracyclines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 2 Donor Bone Marrow-Derived Mesenchymal Stem Cells in Controlling Heart Failure in Patients with Cardiomyopathy Caused by Anthracyclines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 3 The Transendocardial Autologous Cells (hMSC) or (hMSC) and (hCSC) in Ischemic Heart Failure Trial . . . . . . . . . . . . . . . . . . . . 13 4 Regression of Fibrosis and Reversal of Diastolic Dysfunction in HFPEF Patients Treated with Allogeneic CDCs . . . . . . . . . . . . . . . 21 5 Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure . . . . . . . 25 Part II H eart Failure (Europe) 6 Allogeneic Stem Cell Therapy in Heart Failure . . . . . . . . . . . . . . . . . . 33 7 Stem Cell Therapy in Advanced Heart Failure . . . . . . . . . . . . . . . . . . 37 8 Stem Cell Therapy in Ischemic Non- treatable Cardiac Disease . . . . . 39 9 Infusion Intracoronary of Mononuclear Autologous Adult Non Expanded Stem Cells of Bone Marrow on Functional Recovery in Patients with Idiopathic Dilated Cardiomyopathy and Heart Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 vii viii Contents 10 Cell Therapy in HFpEF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 11 Compare the Effects of Single Versus Repeated Intracoronary Application of Autologous Bone Marrow-Derived Mononuclear Cells on Mortality in Patients with Chronic Post-infarction Heart Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 12 Impact of Intracoronary Injection of Autologous BMMC for LV Contractility and Remodeling in Patients with STEMI . . . . . 55 13 Stem Cell Therapy in Non-ischemic, Non- treatable Dilated Cardiomyopathies II: A Pilot Study . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Part III H eart Failure (Iran) 14 IMMNC-HF: IntraMyocardial Injection of Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients . . . . . . . . . . . . . . . 67 15 ICMNC-HF: IntraCoronary Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71 Part IV H eart Failure (China) 16 Treating Heart Failure with hPSC-CMs . . . . . . . . . . . . . . . . . . . . . . . . 77 Part V Diabetes Mellitus: Type 1 Diabetes (United States) 17 Cellular Therapy for Type 1 Diabetes Using Mesenchymal Stem Cells . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85 18 A Pilot Study of the Therapeutic Potential of Stem Cell Educator Therapy in Type 1 Diabetes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 19 Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 20 Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease . . . 97 Part VI D iabetes Mellitus: Type 1 Diabetes (China) 21 Stem Cell Educator Therapy in Diabetes . . . . . . . . . . . . . . . . . . . . . . . 103 22 Reversal of Type 1 Diabetes in Children by Stem Cell Educator Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107 Part VII Diabetes Mellitus: Type 1 Diabetes (China/Spain) 23 Stem Cell Educator Therapy in Type 1 Diabetes . . . . . . . . . . . . . . . . . 113 Contents ix Part VIII Diabetes Mellitus: Type 1 Diabetes (South America) 24 Mesenchymal Stem Cells in Patients with Type 1 Diabetes Mellitus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119 Part IX D iabetes Mellitus: Type 1 Diabetes (Canada) 25 Stem Cell Mobilization (Plerixafor) and Immunologic Reset in Type 1 Diabetes (T1DM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125 Part X Diabetes Mellitus: Type 1 Diabetes (Middle East) 26 Mesenchymal Stem Cell Transplantation in Newly Diagnosed Type 1 Diabetes Patients (MSCTXT1DM) . . . . . . . . . . . . . . . . . . . . . . 133 27 Use of Stem Cells in Diabetes Mellitus Type 1 . . . . . . . . . . . . . . . . . . . 139 Part XI D iabetes Mellitus: Type 1 Diabetes (Sweden) 28 Wharton’s Jelly-Derived Mesenchymal Stromal Cell-Repeated Treatment of Adult Patients Diagnosed with Type I Diabetes . . . . . . 145 Part XII Diabetes Mellitus: Type 2 Diabetes (United States) 29 Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial Dysfunction in Diabetic Subjects (ACESO) . . . . . . . . 151 30 Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease . . . 157 Part XIII Diabetes Mellitus: Type 2 Diabetes (China) 31 Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cell Transplantation in Patients with Type 2 Diabetes Mellitus . . . . . . . . 163 32 Stem Cell Educator Therapy in Diabetes . . . . . . . . . . . . . . . . . . . . . . . 167 33 Clinical Study of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Type 2 Diabetic Nephropathy . . . . . . . . . . . . . . . . 171 Part XIV Diabetes Mellitus: Type 2 Diabetes (Near East) 34 BM-MNC and UCMSC for Type 2 Diabetes Mellitus Patients . . . . . 175 Part XV Diabetes Mellitus: Type 2 Diabetes (Vietnam) 35 BM-MNC and UC-MSC Infusion for Type 2 Diabetes Mellitus Patients (T2DM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181 x Contents Part XVI Other Thoughts 36 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188 Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191 Part I Heart Failure (United States)

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