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A protocol for cell therapy infusion in neonates
Cell therapies for neonatal morbidities are progressing to early phase clinical trials. However, protocols for intravenous (IV) delivery of cell therapies to infants have not been evaluated. It has been assumed the cell dose prescribed is the dose delivered. Early in our clinical trial of human amni...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley & Sons, Inc.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8046110/ https://www.ncbi.nlm.nih.gov/pubmed/33405397 http://dx.doi.org/10.1002/sctm.20-0281 |
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author | Baker, Elizabeth K. Wallace, Euan M. Davis, Peter G. Malhotra, Atul Jacobs, Susan E. Hooper, Stuart B. Lim, Rebecca |
author_facet | Baker, Elizabeth K. Wallace, Euan M. Davis, Peter G. Malhotra, Atul Jacobs, Susan E. Hooper, Stuart B. Lim, Rebecca |
author_sort | Baker, Elizabeth K. |
collection | PubMed |
description | Cell therapies for neonatal morbidities are progressing to early phase clinical trials. However, protocols for intravenous (IV) delivery of cell therapies to infants have not been evaluated. It has been assumed the cell dose prescribed is the dose delivered. Early in our clinical trial of human amnion epithelial cells (hAECs), we observed cells settling in the syringe and IV tubing used to deliver the suspension. The effect on dose delivery was unknown. We aimed to quantify this observation and determine an optimal protocol for IV delivery of hAECs to extremely preterm infants. A standard pediatric infusion protocol was modeled in the laboratory. A syringe pump delivered the hAEC suspension over 60 minutes via a pediatric blood transfusion set (200‐μm filter and 2.2 mL IV line). The infusion protocol was varied by agitation methods, IV‐line volumes (0.2‐2.2 mL), albumin concentrations (2% vs 4%), and syringe orientations (horizontal vs vertical) to assess whether these variables influenced the dose delivered. The influence of flow rate (3‐15 mL/h) was assessed after other variables were optimized. The standard infusion protocol delivered 17.6% ± 9% of the intended hAEC dose. Increasing albumin concentration to 4%, positioning the syringe and IV line vertically, and decreasing IV‐line volume to 0.6 mL delivered 99.7% ± 13% of the intended hAEC dose. Flow rate did not affect dose delivery. Cell therapy infusion protocols must be considered. We describe the refinement of a cell infusion protocol that delivers intended cell doses and could form the basis of future neonatal cell delivery protocols. |
format | Online Article Text |
id | pubmed-8046110 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley & Sons, Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-80461102021-04-16 A protocol for cell therapy infusion in neonates Baker, Elizabeth K. Wallace, Euan M. Davis, Peter G. Malhotra, Atul Jacobs, Susan E. Hooper, Stuart B. Lim, Rebecca Stem Cells Transl Med Standards, Protocols, Policies, and Regulations for Cell‐based Therapies Cell therapies for neonatal morbidities are progressing to early phase clinical trials. However, protocols for intravenous (IV) delivery of cell therapies to infants have not been evaluated. It has been assumed the cell dose prescribed is the dose delivered. Early in our clinical trial of human amnion epithelial cells (hAECs), we observed cells settling in the syringe and IV tubing used to deliver the suspension. The effect on dose delivery was unknown. We aimed to quantify this observation and determine an optimal protocol for IV delivery of hAECs to extremely preterm infants. A standard pediatric infusion protocol was modeled in the laboratory. A syringe pump delivered the hAEC suspension over 60 minutes via a pediatric blood transfusion set (200‐μm filter and 2.2 mL IV line). The infusion protocol was varied by agitation methods, IV‐line volumes (0.2‐2.2 mL), albumin concentrations (2% vs 4%), and syringe orientations (horizontal vs vertical) to assess whether these variables influenced the dose delivered. The influence of flow rate (3‐15 mL/h) was assessed after other variables were optimized. The standard infusion protocol delivered 17.6% ± 9% of the intended hAEC dose. Increasing albumin concentration to 4%, positioning the syringe and IV line vertically, and decreasing IV‐line volume to 0.6 mL delivered 99.7% ± 13% of the intended hAEC dose. Flow rate did not affect dose delivery. Cell therapy infusion protocols must be considered. We describe the refinement of a cell infusion protocol that delivers intended cell doses and could form the basis of future neonatal cell delivery protocols. John Wiley & Sons, Inc. 2021-01-06 /pmc/articles/PMC8046110/ /pubmed/33405397 http://dx.doi.org/10.1002/sctm.20-0281 Text en © 2020 The Authors. stem cells translational medicine published by Wiley Periodicals LLC on behalf of AlphaMed Press https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Standards, Protocols, Policies, and Regulations for Cell‐based Therapies Baker, Elizabeth K. Wallace, Euan M. Davis, Peter G. Malhotra, Atul Jacobs, Susan E. Hooper, Stuart B. Lim, Rebecca A protocol for cell therapy infusion in neonates |
title | A protocol for cell therapy infusion in neonates |
title_full | A protocol for cell therapy infusion in neonates |
title_fullStr | A protocol for cell therapy infusion in neonates |
title_full_unstemmed | A protocol for cell therapy infusion in neonates |
title_short | A protocol for cell therapy infusion in neonates |
title_sort | protocol for cell therapy infusion in neonates |
topic | Standards, Protocols, Policies, and Regulations for Cell‐based Therapies |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8046110/ https://www.ncbi.nlm.nih.gov/pubmed/33405397 http://dx.doi.org/10.1002/sctm.20-0281 |
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