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Your search keyword '"Projetti Pensi, M"' showing total 3 results
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3 results on '"Projetti Pensi, M"'

1. Human Neural Stem Cell-Based Drug Product: Clinical and Nonclinical Characterization

Author

Profico, D, Gelati, M, Ferrari, D, Sgaravizzi, G, Ricciolini, C, Projetti Pensi, M, Muzi, G, Cajola, L, Copetti, M, Ciusani, E, Pugliese, R, Gelain, F, Vescovi, A, Profico D. C., Gelati M., Ferrari D., Sgaravizzi G., Ricciolini C., Projetti Pensi M., Muzi G., Cajola L., Copetti M., Ciusani E., Pugliese R., Gelain F., Vescovi A. L., Profico, D, Gelati, M, Ferrari, D, Sgaravizzi, G, Ricciolini, C, Projetti Pensi, M, Muzi, G, Cajola, L, Copetti, M, Ciusani, E, Pugliese, R, Gelain, F, Vescovi, A, Profico D. C., Gelati M., Ferrari D., Sgaravizzi G., Ricciolini C., Projetti Pensi M., Muzi G., Cajola L., Copetti M., Ciusani E., Pugliese R., Gelain F., and Vescovi A. L.

Abstract

Translation of cell therapies into clinical practice requires the adoption of robust production protocols in order to optimize and standardize the manufacture and cryopreservation of cells, in compliance with good manufacturing practice regulations. Between 2012 and 2020, we conducted two phase I clinical trials (EudraCT 2009-014484-39, EudraCT 2015-004855-37) on amyotrophic lateral sclerosis secondary progressive multiple sclerosis patients, respectively, treating them with human neural stem cells. Our production process of a hNSC-based medicinal product is the first to use brain tissue samples extracted from fetuses that died in spontaneous abortion or miscarriage. It consists of selection, isolation and expansion of hNSCs and ends with the final pharmaceutical formulation tailored to a specific patient, in compliance with the approved clinical protocol. The cells used in these clinical trials were analyzed in order to confirm their microbiological safety; each batch was also tested to assess identity, potency and safety through morphological and functional assays. Preclinical, clinical and in vitro nonclinical data have proved that our cells are safe and stable, and that the production process can provide a high level of reproducibility of the cultures. Here, we describe the quality control strategy for the characterization of the hNSCs used in the above-mentioned clinical trials.

Published
2022

2. Human Neural Stem Cell-Based Drug Product: Clinical and Nonclinical Characterization

Author

Daniela Celeste Profico, Maurizio Gelati, Daniela Ferrari, Giada Sgaravizzi, Claudia Ricciolini, Massimo Projetti Pensi, Gianmarco Muzi, Laura Cajola, Massimiliano Copetti, Emilio Ciusani, Raffaele Pugliese, Fabrizio Gelain, Angelo Luigi Vescovi, Profico, D, Gelati, M, Ferrari, D, Sgaravizzi, G, Ricciolini, C, Projetti Pensi, M, Muzi, G, Cajola, L, Copetti, M, Ciusani, E, Pugliese, R, Gelain, F, and Vescovi, A

Subjects
Cryopreservation, standardization, GMP, Organic Chemistry, Amyotrophic Lateral Sclerosis, Reproducibility of Results, General Medicine, Catalysis, Computer Science Applications, Inorganic Chemistry, neural stem cell, Neural Stem Cells, ATMP production, Humans, Physical and Theoretical Chemistry, quality control, Molecular Biology, Spectroscopy
Abstract

Translation of cell therapies into clinical practice requires the adoption of robust production protocols in order to optimize and standardize the manufacture and cryopreservation of cells, in compliance with good manufacturing practice regulations. Between 2012 and 2020, we conducted two phase I clinical trials (EudraCT 2009-014484-39, EudraCT 2015-004855-37) on amyotrophic lateral sclerosis secondary progressive multiple sclerosis patients, respectively, treating them with human neural stem cells. Our production process of a hNSC-based medicinal product is the first to use brain tissue samples extracted from fetuses that died in spontaneous abortion or miscarriage. It consists of selection, isolation and expansion of hNSCs and ends with the final pharmaceutical formulation tailored to a specific patient, in compliance with the approved clinical protocol. The cells used in these clinical trials were analyzed in order to confirm their microbiological safety; each batch was also tested to assess identity, potency and safety through morphological and functional assays. Preclinical, clinical and in vitro nonclinical data have proved that our cells are safe and stable, and that the production process can provide a high level of reproducibility of the cultures. Here, we describe the quality control strategy for the characterization of the hNSCs used in the above-mentioned clinical trials.

Published
2022

3. Human Neural Stem Cell-Based Drug Product: Clinical and Nonclinical Characterization.

Author

Profico DC, Gelati M, Ferrari D, Sgaravizzi G, Ricciolini C, Projetti Pensi M, Muzi G, Cajola L, Copetti M, Ciusani E, Pugliese R, Gelain F, and Vescovi AL

Subjects
Humans, Reproducibility of Results, Cryopreservation, Quality Control, Neural Stem Cells, Amyotrophic Lateral Sclerosis drug therapy
Abstract

Translation of cell therapies into clinical practice requires the adoption of robust production protocols in order to optimize and standardize the manufacture and cryopreservation of cells, in compliance with good manufacturing practice regulations. Between 2012 and 2020, we conducted two phase I clinical trials (EudraCT 2009-014484-39, EudraCT 2015-004855-37) on amyotrophic lateral sclerosis secondary progressive multiple sclerosis patients, respectively, treating them with human neural stem cells. Our production process of a hNSC-based medicinal product is the first to use brain tissue samples extracted from fetuses that died in spontaneous abortion or miscarriage. It consists of selection, isolation and expansion of hNSCs and ends with the final pharmaceutical formulation tailored to a specific patient, in compliance with the approved clinical protocol. The cells used in these clinical trials were analyzed in order to confirm their microbiological safety; each batch was also tested to assess identity, potency and safety through morphological and functional assays. Preclinical, clinical and in vitro nonclinical data have proved that our cells are safe and stable, and that the production process can provide a high level of reproducibility of the cultures. Here, we describe the quality control strategy for the characterization of the hNSCs used in the above-mentioned clinical trials.

Published
2022
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