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6 results on '"Grespi V."'

1. Phase I clinical trial of intracerebroventricular transplantation of allogeneic neural stem cells in people with progressive multiple sclerosis

Author

Leone, M, Gelati, M, Profico, D, Gobbi, C, Pravata, E, Copetti, M, Conti, C, Abate, L, Amoruso, L, Apollo, F, Balzano, R, Bicchi, I, Carella, M, Ciampini, A, Colosimo, C, Crociani, P, D'Aloisio, G, Di Viesti, P, Ferrari, D, Fogli, D, Fontana, A, Frondizi, D, Grespi, V, Kuhle, J, Laborante, A, Lombardi, I, Muzi, G, Paci, F, Placentino, G, Popolizio, T, Ricciolini, C, Sabatini, S, Silveri, G, Spera, C, Stephenson, D, Stipa, G, Tinella, E, Zarrelli, M, Zecca, C, Ventura, Y, D'Alessandro, A, Peruzzotti-Jametti, L, Pluchino, S, Vescovi, A, Leone M. A., Gelati M., Profico D. C., Gobbi C., Pravata E., Copetti M., Conti C., Abate L., Amoruso L., Apollo F., Balzano R. F., Bicchi I., Carella M., Ciampini A., Colosimo C., Crociani P., D'Aloisio G., Di Viesti P., Ferrari D., Fogli D., Fontana A., Frondizi D., Grespi V., Kuhle J., Laborante A., Lombardi I., Muzi G., Paci F., Placentino G., Popolizio T., Ricciolini C., Sabatini S., Silveri G., Spera C., Stephenson D., Stipa G., Tinella E., Zarrelli M., Zecca C., Ventura Y., D'Alessandro A., Peruzzotti-Jametti L., Pluchino S., Vescovi A. L., Leone, M, Gelati, M, Profico, D, Gobbi, C, Pravata, E, Copetti, M, Conti, C, Abate, L, Amoruso, L, Apollo, F, Balzano, R, Bicchi, I, Carella, M, Ciampini, A, Colosimo, C, Crociani, P, D'Aloisio, G, Di Viesti, P, Ferrari, D, Fogli, D, Fontana, A, Frondizi, D, Grespi, V, Kuhle, J, Laborante, A, Lombardi, I, Muzi, G, Paci, F, Placentino, G, Popolizio, T, Ricciolini, C, Sabatini, S, Silveri, G, Spera, C, Stephenson, D, Stipa, G, Tinella, E, Zarrelli, M, Zecca, C, Ventura, Y, D'Alessandro, A, Peruzzotti-Jametti, L, Pluchino, S, Vescovi, A, Leone M. A., Gelati M., Profico D. C., Gobbi C., Pravata E., Copetti M., Conti C., Abate L., Amoruso L., Apollo F., Balzano R. F., Bicchi I., Carella M., Ciampini A., Colosimo C., Crociani P., D'Aloisio G., Di Viesti P., Ferrari D., Fogli D., Fontana A., Frondizi D., Grespi V., Kuhle J., Laborante A., Lombardi I., Muzi G., Paci F., Placentino G., Popolizio T., Ricciolini C., Sabatini S., Silveri G., Spera C., Stephenson D., Stipa G., Tinella E., Zarrelli M., Zecca C., Ventura Y., D'Alessandro A., Peruzzotti-Jametti L., Pluchino S., and Vescovi A. L.

Abstract

We report the analysis of 1 year of data from the first cohort of 15 patients enrolled in an open-label, first-in-human, dose-escalation phase I study (ClinicalTrials.gov: NCT03282760, EudraCT2015-004855-37) to determine the feasibility, safety, and tolerability of the transplantation of allogeneic human neural stem/progenitor cells (hNSCs) for the treatment of secondary progressive multiple sclerosis. Participants were treated with hNSCs delivered via intracerebroventricular injection in combination with an immunosuppressive regimen. No treatment-related deaths nor serious adverse events (AEs) were observed. All participants displayed stability of clinical and laboratory outcomes, as well as lesion load and brain activity (MRI), compared with the study entry. Longitudinal metabolomics and lipidomics of biological fluids identified time- and dose-dependent responses with increased levels of acyl-carnitines and fatty acids in the cerebrospinal fluid (CSF). The absence of AEs and the stability of functional and structural outcomes are reassuring and represent a milestone for the safe translation of stem cells into regenerative medicines.

Published
2023

2. Human neural stem cells drug product: Microsatellite instability analysis

Author

Grespi, V, Caprera, C, Ricciolini, C, Bicchi, I, Muzi, G, Corsi, M, Ascani, S, Vescovi, A, Gelati, M, Grespi V., Caprera C., Ricciolini C., Bicchi I., Muzi G., Corsi M., Ascani S., Vescovi A. L., Gelati M., Grespi, V, Caprera, C, Ricciolini, C, Bicchi, I, Muzi, G, Corsi, M, Ascani, S, Vescovi, A, Gelati, M, Grespi V., Caprera C., Ricciolini C., Bicchi I., Muzi G., Corsi M., Ascani S., Vescovi A. L., and Gelati M.

Abstract

Introduction In central nervous system neurodegenerative disorders, stem cell-based therapies should be considered as a promising therapeutic approach. The safe use of human Neural Stem Cells (hNSCs) for the treatment of several neurological diseases is currently under evaluation of phase I/II clinical trials. Clinical application of hNSCs require the development of GMP standardized protocols capable of generating high quantities of reproducible and well characterized stem cells bearing stable functional and genetic properties. Aim The aim of this study was to evaluate possible instabilities or modifications of the microsatellite loci in different culture passages because high culture passages represent an in vitro replicative stress leading to senescence. Experimental method: The hNSCs were characterized at different culture time points, from passage 2 to passage 25, by genetic typing at ten microsatellite loci. Conclusion We showed that genetic stability at microsatellite loci is maintained by the cells even at high passages adding a further demonstration of the safety of our hNSCs GMP culture method.

Published
2022

4. Human neural stem cells drug product: Microsatellite instability analysis

Author

Valentina Grespi, Cecilia Caprera, Claudia Ricciolini, Ilaria Bicchi, Gianmarco Muzi, Matteo Corsi, Stefano Ascani, Angelo Luigi Vescovi, Maurizio Gelati, Grespi, V, Caprera, C, Ricciolini, C, Bicchi, I, Muzi, G, Corsi, M, Ascani, S, Vescovi, A, and Gelati, M

Subjects
Multidisciplinary, Neural Stem Cells, Humans, Neural Stem Cell, Cell Differentiation, Microsatellite Instability, Human, Stem Cell Transplantation
Abstract

Introduction In central nervous system neurodegenerative disorders, stem cell-based therapies should be considered as a promising therapeutic approach. The safe use of human Neural Stem Cells (hNSCs) for the treatment of several neurological diseases is currently under evaluation of phase I/II clinical trials. Clinical application of hNSCs require the development of GMP standardized protocols capable of generating high quantities of reproducible and well characterized stem cells bearing stable functional and genetic properties. Aim The aim of this study was to evaluate possible instabilities or modifications of the microsatellite loci in different culture passages because high culture passages represent an in vitro replicative stress leading to senescence. Experimental method: The hNSCs were characterized at different culture time points, from passage 2 to passage 25, by genetic typing at ten microsatellite loci. Conclusion We showed that genetic stability at microsatellite loci is maintained by the cells even at high passages adding a further demonstration of the safety of our hNSCs GMP culture method.

Published
2022
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5. Phase I clinical trial of intracerebroventricular transplantation of allogeneic neural stem cells in people with progressive multiple sclerosis.

Author

Leone MA, Gelati M, Profico DC, Gobbi C, Pravatà E, Copetti M, Conti C, Abate L, Amoruso L, Apollo F, Balzano RF, Bicchi I, Carella M, Ciampini A, Colosimo C, Crociani P, D'Aloisio G, Di Viesti P, Ferrari D, Fogli D, Fontana A, Frondizi D, Grespi V, Kuhle J, Laborante A, Lombardi I, Muzi G, Paci F, Placentino G, Popolizio T, Ricciolini C, Sabatini S, Silveri G, Spera C, Stephenson D, Stipa G, Tinella E, Zarrelli M, Zecca C, Ventura Y, D'Alessandro A, Peruzzotti-Jametti L, Pluchino S, and Vescovi AL

Subjects
Humans, Transplantation, Autologous, Multiple Sclerosis, Chronic Progressive drug therapy, Multiple Sclerosis therapy, Neural Stem Cells, Hematopoietic Stem Cell Transplantation
Abstract

We report the analysis of 1 year of data from the first cohort of 15 patients enrolled in an open-label, first-in-human, dose-escalation phase I study (ClinicalTrials.gov: NCT03282760, EudraCT2015-004855-37) to determine the feasibility, safety, and tolerability of the transplantation of allogeneic human neural stem/progenitor cells (hNSCs) for the treatment of secondary progressive multiple sclerosis. Participants were treated with hNSCs delivered via intracerebroventricular injection in combination with an immunosuppressive regimen. No treatment-related deaths nor serious adverse events (AEs) were observed. All participants displayed stability of clinical and laboratory outcomes, as well as lesion load and brain activity (MRI), compared with the study entry. Longitudinal metabolomics and lipidomics of biological fluids identified time- and dose-dependent responses with increased levels of acyl-carnitines and fatty acids in the cerebrospinal fluid (CSF). The absence of AEs and the stability of functional and structural outcomes are reassuring and represent a milestone for the safe translation of stem cells into regenerative medicines., Competing Interests: Declaration of interests S.P. is founder, CSO, and shareholder (>5%) of CITC Ltd. and Chair of the Scientific Advisory Board at ReNeuron plc., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Published
2023
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6. Human neural stem cells drug product: Microsatellite instability analysis.

Author

Grespi V, Caprera C, Ricciolini C, Bicchi I, Muzi G, Corsi M, Ascani S, Vescovi AL, and Gelati M

Subjects
Cell Differentiation, Humans, Stem Cell Transplantation, Microsatellite Instability, Neural Stem Cells
Abstract

Introduction: In central nervous system neurodegenerative disorders, stem cell-based therapies should be considered as a promising therapeutic approach. The safe use of human Neural Stem Cells (hNSCs) for the treatment of several neurological diseases is currently under evaluation of phase I/II clinical trials. Clinical application of hNSCs require the development of GMP standardized protocols capable of generating high quantities of reproducible and well characterized stem cells bearing stable functional and genetic properties., Aim: The aim of this study was to evaluate possible instabilities or modifications of the microsatellite loci in different culture passages because high culture passages represent an in vitro replicative stress leading to senescence. Experimental method: The hNSCs were characterized at different culture time points, from passage 2 to passage 25, by genetic typing at ten microsatellite loci., Conclusion: We showed that genetic stability at microsatellite loci is maintained by the cells even at high passages adding a further demonstration of the safety of our hNSCs GMP culture method., Competing Interests: The authors have declared that no competing interests exist.

Published
2022
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