Cell Therapy Trials for Stroke: How to Evaluate Safety and Efficacy. Rosalia Mendez-Otero Universidade Federal do Rio de Janeiro Brazil
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1 Cell Therapy Trials for Stroke: How to Evaluate Safety and Efficacy Rosalia Mendez-Otero Universidade Federal do Rio de Janeiro Brazil
2 Stroke: Epidemiology 2 nd leading cause of death in the world (5,47 million, 2002) 1 st cause of disability worldwide Only treatment: tpa (tissue plasminogen activator) <4.5h
3 Therapeutical windows
4 Oclusão da artéria cerebral média: isquemia focal 2009 Centro da lesão Penumbra
5
6
7 DAPI / ED1 BMMC modulate microglia activation 7 days after ischemia A B B
8 There is a therapeutic window for treatment of cortical ischemia with bone marrow-derived cells in rats Functional Evaluation of Forelimb: Cylinder test de Vasconcelos dos Santos,Brain Research 1306 (2010)
9 Mechanism of action of BMSC PARACRINE EFFECT MICROGLIA ANGIOGENESIS TRANSDIFERENTIATION NEUROGENESIS (NEURONAL STEM CELLS) FUSION
10 Conclusion Cell therapy in stroke- Animal models In adult rats subjected to MCA occlusion, different types of Stem Cells administered IV or IA decreased the penumbra area and increased functional recovery Bone marrow derived stem cells (mesenchymal or mononuclear cell fraction) have a beneficial effect in animal models of ischemia (Giraldi-Guimarães et al., Brain Research, 2009; devasconcelos dos Santos A. et l., Brain Research, 2010)
11 Safety and feasibility of autologous bone marrow cell transplantation in patients with ischemic stroke Gabriel R. de Freitas Maria Lucia Mendonça Charles Andre Mauricio Friedrich Approved by CONEP ClinicalTrials.gov NCT
12 Study design Ischemic stroke MCA Acute <10 days IA N=26 Subacute <90 days IA N=6 Subacute <90 days EV N=5 Hospital Procardiaco, Rio de Janeiro Hospital Universitario/UFRJ, Rio de Janeiro Hospital São Lucas/PUC, Porto Alegre
13 Methods Inclusion criteria: Age between 18 and 75 Ischemic stroke involving the MCA territory (CT/ MRI) NIHSS between 4 and 30 Spontaneous recanalization of the MCA by TCD and/or MRI
14 SAFETY AND FEASIBILITY OF BMMNC TRANSPLANTATION IN ACUTE ISCHEMIC STROKE Inclusion criteria: Age 18 to 75; Acute ischemic stroke ( 10days) in the MCA; NIHSS 4 to 30; x 10 6 cells/kg IA N=26
15 Periprocedural Evaluation Continuous EEG monitoring left left MCA right MCA right Continuous TCD monitoring
16 NIHSS Results Patient Follow-up (days) Friedrich et al., Cell Transplantation, 2012
17 Migration an homing of BMMNC in acute stroke 10% of the BMMNCs labeled with 99m-Tc
18 Intra-arterial Injected Autologous Bone Marrow Mononuclear Cell Distribution by Radioactive Labeling in Acute Ischemic Stroke (D 7) a b c d 10 % BMMC labeled with 99mTc Correa et al., 2007, Clinical Nuclear Medicine Volume 32, Number 11, November 2007 p
19 Conclusion I Intra-arterial injection of autologous BMMC in the MCA is feasible and safe in acute stroke In acute patients BMMCs labeled with Tc migrate to the lesion site Phase II/III studies will be required to evaluate the efficacy of BMMC transplantation in acute stroke
20 Study design Ischemic stroke MCA Acute <10 days IA N=26 Subacute <90 days IA N=6 Subacute <90 days EV N=5 Hospital Procardiaco, Rio de Janeiro Hospital Universitario/UFRJ, Rio de Janeiro Hospital São Lucas/PUC, Porto Alegre
21 SAFETY AND FEASIBILITY OF BMMNC TRANSPLANTATION IN ISCHEMIC STROKE Inclusion criteria: Age 18 to 75; Acute ischemic stroke ( 90days) in the MCA; NIHSS 4 to 30; x 10 6 cells/kg IA /EV
22 99mTc-BMMC migrate to the ipsilesional hemisphere in subacute patients P1 P2 P1 67 days after stroke P2 82 days after stroke
23
24 Conclusions IA or EV injection of autologous BMMC is feasible and safe in acute and subacute stroke. In both acute and subacute patients BMMC migrate to the lesion site and can be traced for at least 24 hs Phase II/III studies to assess the efficacy of BMMCs in acute stroke Approved and funded by PROBITEC (Brazil- Argentina) Coordinators: Gabriel R de Freitas- BRAZIL Sebastian Ameriso - ARGENTINA
25 Main investigators-clinical Trials Gabriel R. de Freitas MD, PhD Maria L Mendonça MD Mauricio Friedrich MD, PhD Charles Andre MD, PhD Valeria Battistella MD Lea B. Fonseca MD, PhD Bianca Gutfilen PhD Eduardo Wajnberg MD, PhD Emerson Gaspareto Md, PhD Regina Goldenberg PhD Funding Ministry of Health and Ministry of Science and Technology/Brazil - Grant MS/MCT /2005-7
26 THANK YOU
Stroke is responsible for *11.1% of all deaths, and is the
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