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[{"orgOrder":0,"company":"Stemedica Cell Technologies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"First COVID-19 Patient Treated Using Stemedica Ischemia-Tolerant Allogeneic Mesenchymal Bone Marrow Cells","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Undisclosed","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Undisclosed"},{"orgOrder":0,"company":"Stemedica Cell Technologies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Grants IND Approval for Phase II Clinical Trial Using Stemedica's itMSC Therapy for COVID-19 Patients","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"IND Enabling"},{"orgOrder":0,"company":"Stemedica Cell Technologies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Stemedica Initiating Phase IIb\/III Clinical Trial for Patients with Chronic Ischemic Stroke","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Phase I\/ Phase II"}]

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            Details:

            Stemedica plans to initiate a Phase IIb/III, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and tolerability of a single intravenous injection of allogeneic adult mesenchymal bone marrow stem cell to subjects with ischemic stroke.

            Lead Product(s): Allogeneic Adult Mesenchymal Bone Marrow Stem Cell

            Therapeutic Area: Neurology Product Name: Undisclosed

            Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 19, 2023

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            Prior to submission of an IND, fourteen critically ill COVID-19 patients were treated on Emergency Use and Expanded Use INDs. The stem cell treatment resulted in an improved clinical course for the patients within 24-48 hours of receiving the therapy.

            Lead Product(s): Ischemic-tolerant mesenchymal stem cells

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 27, 2020

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            This IND application for emergency use was supported by pre-clinical data in an acute respiratory distress syndrome (ARDS) model.

            Lead Product(s): Ischemic-tolerant mesenchymal stem cells

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Undisclosed Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 20, 2020

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