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10 results on '"Vidro-Casiano, Mayra"'

3. Dose Comparison Study of Allogeneic Mesenchymal Stem Cells in Patients With Ischemic Cardiomyopathy (The TRIDENT Study)

Author

Florea, Victoria, Rieger, Angela C., DiFede, Darcy L., El-Khorazaty, Jill, Natsumeda, Makoto, Banerjee, Monisha N., Tompkins, Bryon A., Khan, Aisha, Schulman, Ivonne H., Landin, Ana Marie, Mushtaq, Muzammil, Golpanian, Samuel, Lowery, Maureen H., Byrnes, John J., Hendel, Robert C., Cohen, Mauricio G., Valasaki, Krystalenia, Pujol, Marietsy V., Ghersin, Eduard, Miki, Roberto, Delgado, Cindy, Abuzeid, Fouad, Vidro-Casiano, Mayra, Saltzman, Russell G., DaFonseca, Daniel, Caceres, Lina V., Ramdas, Kevin N., Mendizabal, Adam, Heldman, Alan W., Mitrani, Raul D., and Hare, Joshua M.

Published
2017
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4. Allogeneic Human Mesenchymal Stem Cell Infusions for Aging Frailty

Author

Golpanian, Samuel, DiFede, Darcy L, Khan, Aisha, Schulman, Ivonne Hernandez, Landin, Ana Marie, Tompkins, Bryon A, Heldman, Alan W, Miki, Roberto, Goldstein, Bradley J, Mushtaq, Muzammil, Levis-Dusseau, Silvina, Byrnes, John J, Lowery, Maureen, Natsumeda, Makoto, Delgado, Cindy, Saltzman, Russell, Vidro-Casiano, Mayra, Pujol, Marietsy V, Da Fonseca, Moisaniel, Oliva, Anthony A, Jr, Green, Geoff, Premer, Courtney, Medina, Audrey, Valasaki, Krystalenia, Florea, Victoria, Anderson, Erica, El-Khorazaty, Jill, Mendizabal, Adam, Goldschmidt-Clermont, Pascal J, and Hare, Joshua M

Published
2017
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5. Allogeneic Mesenchymal Stem Cells Ameliorate Aging Frailty: A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Author

Tompkins, Bryon A, DiFede, Darcy L, Khan, Aisha, Landin, Ana Marie, Schulman, Ivonne Hernandez, Pujol, Marietsy V, Heldman, Alan W, Miki, Roberto, Goldschmidt-Clermont, Pascal J, Goldstein, Bradley J, Mushtaq, Muzammil, Levis-Dusseau, Silvina, Byrnes, John J, Lowery, Maureen, Natsumeda, Makoto, Delgado, Cindy, Saltzman, Russell, Vidro-Casiano, Mayra, Da Fonseca, Moisaniel, Golpanian, Samuel, Premer, Courtney, Medina, Audrey, Valasaki, Krystalenia, Florea, Victoria, Anderson, Erica, El-Khorazaty, Jill, Mendizabal, Adam, Green, Geoff, Oliva, Anthony A, and Hare, Joshua M

Published
2017
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6. Abstract 9813: A Randomized, Double Blind, Clinical Trial to Evaluate Safety and Efficacy of Allogeneic Mesenchymal Human Stem Cells Infusion Therapy for Endothelial Dysfunction in Diabetic Subjects (ACESO)

Author

Saltzman, Russell G, primary, Schulman, Ivonne H, additional, Hurwitz, Barry E, additional, Li, Hua, additional, caceres, lina V, additional, Vidro-Casiano, Mayra, additional, Tovar, Jairo A, additional, Desire, Yvenie, additional, Porras, Valeria, additional, Soto, Jeanette, additional, Khan, Aisha, additional, Jayaweera, Dushyantha, additional, and Hare, Joshua M, additional

Published
2021
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7. Genetic determinants of responsiveness to mesenchymal stem cell injections in non-ischemic dilated cardiomyopathy

Author

Rieger, Angela C., primary, Myerburg, Robert J., additional, Florea, Victoria, additional, Tompkins, Bryon A., additional, Natsumeda, Makoto, additional, Premer, Courtney, additional, Khan, Aisha, additional, Schulman, Ivonne H., additional, Vidro-Casiano, Mayra, additional, DiFede, Darcy L., additional, Heldman, Alan W., additional, Mitrani, Raul, additional, and Hare, Joshua M., additional

Published
2019
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8. Unique Aspects of the Design of Phase I/II Clinical Trials of Stem Cell Therapy

Author

Schulman, Ivonne H., Balkan, Wayne, Saltzman, Russell, DaFonseca, Daniel, Caceres, Lina V., Delgado, Cindy, Pujol, Marietsy V., Ramdas, Kevin N., Tovar, Jairo, Vidro-Casiano, Mayra, Hare, Joshua M., Schulman, Ivonne H., Balkan, Wayne, Saltzman, Russell, DaFonseca, Daniel, Caceres, Lina V., Delgado, Cindy, Pujol, Marietsy V., Ramdas, Kevin N., Tovar, Jairo, Vidro-Casiano, Mayra, and Hare, Joshua M.

Abstract

This chapter will review the unique aspects and limitations of the design of phase I/II (safety and efficacy) clinical trials of stem cell therapy. Although the classical pharmacologic principles applicable to drugs are not applicable to biologic (live cell) therapeutic agents, an important stage in the development of any new therapeutic agent is the establishment of an optimal dosage and delivery route. This can be particularly challenging when the treatment is a biologic agent, such as stem cells, that may exert its therapeutic effects via complex or poorly understood mechanisms. To date, clinical studies have shown inconsistent findings regarding the relationship between cell dose and clinical outcomes. This can be at least partially attributed to variations in donor cell type, source, characteristics, dosing/concentration, delivery route, underlying mechanisms of action, and efficacy endpoints tested. The current recommendations will be reviewed herein to give new investigators a general understanding of the unique issues that need to be considered and addressed when designing a stem cell therapy phase I/II clinical trial.

Published
2018
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9. Randomized Comparison of Allogeneic Vs. Autologous Mesenchymal Stem Cells for Non-lschemic Dilated Cardiomyopathy: POSEIDON-DCM Trial

Author

Hare, Joshua M., DiFede, Darcy L., Castellanos, Angela M., Florea, Victoria, Landin, Ana M., El-Khorazaty, Jill, Khan, Aisha, Mushtaq, Muzammil, Lowery, Maureen H., Byrnes, John J., Hendel, Robert C., Cohen, Mauricio G., Alfonso, Carlos E., Valasaki, Krystalenia, Pujol, Marietsy V., Golpanian, Samuel, Ghersin, Eduard, Fishman, Joel E., Pattany, Pradip, Gomes, Samirah A., Delgado, Cindy, Miki, Roberto, Abuzeid, Fouad, Vidro-Casiano, Mayra, Premer, Courtney, Medina, Audrey, Porras, Valeria, Hatzistergos, Konstantinos E., Anderson, Erica, Mendizabal, Adam, Mitrani, Raul, and Heldman, Alan W.

Subjects
Cardiology and Cardiovascular Medicine
Published
2016
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10. Randomized Comparison of Allogeneic Versus Autologous Mesenchymal Stem Cells for Nonischemic Dilated Cardiomyopathy

Author

Hare, Joshua M., primary, DiFede, Darcy L., additional, Rieger, Angela C., additional, Florea, Victoria, additional, Landin, Ana M., additional, El-Khorazaty, Jill, additional, Khan, Aisha, additional, Mushtaq, Muzammil, additional, Lowery, Maureen H., additional, Byrnes, John J., additional, Hendel, Robert C., additional, Cohen, Mauricio G., additional, Alfonso, Carlos E., additional, Valasaki, Krystalenia, additional, Pujol, Marietsy V., additional, Golpanian, Samuel, additional, Ghersin, Eduard, additional, Fishman, Joel E., additional, Pattany, Pradip, additional, Gomes, Samirah A., additional, Delgado, Cindy, additional, Miki, Roberto, additional, Abuzeid, Fouad, additional, Vidro-Casiano, Mayra, additional, Premer, Courtney, additional, Medina, Audrey, additional, Porras, Valeria, additional, Hatzistergos, Konstantinos E., additional, Anderson, Erica, additional, Mendizabal, Adam, additional, Mitrani, Raul, additional, and Heldman, Alan W., additional

Published
2017
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