Therapeutic Potential of Cells Derived from Gestational Tissues: A coming of age. Dr Roisin Deane Cell Care Australia Pty Ltd

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1 Therapeutic Potential of Cells Derived from Gestational Tissues: A coming of age Dr Roisin Deane Cell Care Australia Pty Ltd

2 What are Gestational Stem Cells? Stem cells isolated from the gestational tissues at birth HSC MSC Undifferentiated Stem Cells Endothelial progenitors Very Small Embryonic-Like cells? Neural stem cells? Regenerative Medicine Not only Stem cells. Regulatory T-cells Dendritic cells Monocytes Immune therapies

3 Therapeutic Potential of Gestational Cells

4 Cord Blood As a source of Haemopoietic Stem Cells (that can be used now) For neurological conditions (potential in future) Immune modulation (potential in future) Cord Tissue As a source of Mesenchymal Stem Cells

5 Autologous Cord Blood HSCT Non-haemopoietic tumours (eg neuroblastoma) Aplastic anaemia Controversy over use in leukaemia contamination argument flawed predisposition argument impossible to confirm or deny Autologous HSCT used in adult leukaemia s Basecke J et al. Transcription of AML1/ETO in bone marrow and cord blood of individuals without acute myelogenous leukemia. Blood (2002) 100:2267- Wiemels 2268 JL et al. In utero origin of t(8;21) AML1-ETO translocations in childhood Future acute use (eg myeloid as adults) leukemia. much more Blood likely (2002) 99: Estimated 1 in out of 22 (27%) normal adult bone marrow samples and 63 out of 156 (40%) 35% normal of Guthrie cord blood spot samples samples tested from children were positive with AML1/ETO for the same positive transcript AML positive Depends for on the HSC transcript expansion technologies A number of technologies under development Phase 2 and 3 trials underway

6 Cord Blood Neurological Conditions Animal studies Positive results in spinal cord injury, stroke, hypoxic brain injury Mechanism(s) unknown neural progenitors? stem cell plasticity? anti-inflammatory? immune modulation? endogenous stem cell recruitment?

7 Over the past few years, accumulating data is suggesting that hucb cell transplantation has an enormous potential in treatment of neurological diseases. Rosenkranz and Meier, 2011 K. Rosenkranz, C. Meier / Annals of Anatomy 193 (2011)

8 Neurological trials using Cord Blood Cord Blood Keep it. Donate it. Just don t throw it away! Title Institution ID A Randomized Study of Autologous Umbilical Cord Blood Reinfusion in Children With Cerebral Palsy Safety and Effectiveness of Cord Blood Stem Cell Infusion for the Treatment of Cerebral Palsy in Children Duke University Georgia Health Sciences University NCT NCT Cord Blood for Neonatal Hypoxic-ischemic Encephalopathy Duke University NCT Safety Study of Umbilical Cord Blood To Treat Pediatric Traumatic Brian Injury The University of Texas Health Science Center, Houston NCT Autologous Umbilical Cord Blood Transfusion for Preterm Neonates Ain Shams University NCT Safety and Feasibility of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord Characterization of the Cord Blood Stem Cell in Situation of Neonatal Asphyxia (NEOCORD) Allogenic Umbilical Cord Blood and Erythropoietin Combination Therapy for Cerebral Palsy Umbilical Cord Blood Mononuclear Cell Transplant to Treat Chronic Spinal Cord Injury China Spinal Cord Injury Network Assistance Publique Hopitaux De Marseille Sung Kwang Medical Foundation China Spinal Cord Injury Network NCT NCT NCT NCT

9 96 children Control group (32 children) rehabilitation only EPO group (33 children) rehabilitation plus EPO UCB group (31 children) rehabilitation plus EPO plus allo UCB EPO only no effect EPO + UCB improved on all functional, structural and metabolic measures No adverse events

10 UCB Improved all outcome measures

11 HLA match is important Cord Blood Keep it. Donate it. Just don t throw it away! As many outcome scales present favorable responses when HLAs are matched, immunity is a considerable factor in allogeneic cell therapy. This finding also suggests great potential for autologous UCB treatment in patients with CP.

12 UCB in Cerebral Palsy But How? Cord Blood Keep it. Donate it. Just don t throw it away! In animal models Positive results with UCB Don t appear to cross blood-brain barrier Don t contribute to new neurones Recent studies in a sheep model show that ischaemic lambs brains have same number of neurones but fail to mature Mechanism of Action? Induction of maturation/differentiation? Increased number of dendritic arbor and synapse connections? Perhaps explains apparent speed of effect

13 Cord Blood Immune Modulation Rich source of potent regulatory T-cells Easier to isolate, more extensive capacity for expansion (4-10 x adult PB) Animal studies show suppression of autoimmune processes using autologous neonatal cells Prevent development of T1D in NOD mice Potential therapeutic application in autoimmune diseases such as Type 1 Diabetes

14 Tregs and Diabetes Type 1 Diabetes is caused by dysregulation of self tolerance, leading to destruction of pancreatic b cells Treatment of diabetes using autologous Cord Blood to restore self tolerance Florida University 23 children Initially lower insulin requirements (some to nil) Benefits not sustained Australian pilot trial to test feasibility of treating earlier in the course of autoimmunity Planned multicentre RCT to follow

15 CHW/Cell Care trial Florida trial

16 Autologous blood in T1D Mother, father or sib with T1D 6% risk of T1D in children Collect UCB Monitor for Autoantibodies Multiple Autoantibodies present 50% risk of T1D within 2 years Randomise Reinfuse UCB Monitor for abnormal glucose tolerance Monitor for abnormal glucose tolerance Reinfuse UCB

17 Immune Clinical Trials using Cord Blood Cord Blood Keep it. Donate it. Just don t throw it away! Title Infusion of Expanded Cord Blood T Cells Infusion of Allogeneic Umbilical Cord Blood-Derived CD19-Specific T Cells T-Regulatory Cell Infusion Post Umbilical Cord Blood Transplant in Patients With Advanced Hematologic Cancer Umbilical Cord Blood T-Regulatory Cell Infusion Followed by Donor Umbilical Cord Blood Transplant in Treating Patients With High-Risk Leukemia or Other Hematologic Diseases Umbilical Cord Blood Infusion to Treat Type 1 Diabetes Cord Blood Infusion for Type 1 Diabetes Mellitus (T1DM) Cord Blood Plus Vitamin D and Omega 3s in T1D Institution M.D. Anderson Cancer Center M.D. Anderson Cancer Center Masonic Cancer Center, University of Minnesota Masonic Cancer Center, University of Minnesota University of Florida Technische Universität München University of Florida

18 Gestational tissue MSC s Can be obtained from cord (Wharton s jelly) or placenta Properties similar to MSC s from other tissues Same advantages as other gestational tissues Early trials being undertaken Most immune modulation Future potential for bone and cartilage treatments

19 Clinical Trials using MSC Cord Blood Keep it. Donate it. Just don t throw it away! Title Institution ID Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Myelodysplastic Syndromes Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Severe Aplastic Anemia Shandong University Shandong University NCT NCT Umbilical Cord Mesenchymal Stem Cells for Patients With Liver Cirrhosis Beijing 302 Hospital NCT Mesenchymal Stem Cells for the Treatment of MS Safety and Efficacy Study of Umbilical Cord Blood-Derived Mesenchymal Stem Cells to Promote Engraftment of Unrelated Hematopoietic Stem Cell Transplantation Hadassah Medical Organization Medipost Co Ltd NCT NCT Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis Qingdao University NCT Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes Mellitus Qingdao University NCT Umbilical Cord Mesenchymal Stem Cells Infusion Via Hepatic Artery in Cirrhosis Patients Qingdao University NCT Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot Qingdao University NCT Treatment of Patients With Newly Onset of Type 1 Diabetes With Mesenchymal Stem Cells Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Hereditary Ataxia Mesenchymal Stem Cells in Critical Limb Ischemia Intraarterial Infusion of Autologous Mesenchymal Stem Cells From Adipose Tissue in Diabetic Patients With Chronic Critical Limb Ischemia Uppsala University Hospital Shenzhen Beike Bio- Technology Co., Ltd. Stempeutics Research Pvt Ltd Fundacion Progreso y Salud, Spain NCT NCT NCT NCT

20 Conclusions Paradigm shift in Regenerative Medicine Replace damaged cells Support endogenous repair Reduce inflammation, apoptosis Immune modulation Recruit endogenous stem cells UCB Are UCB cells primed for repair?

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