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The establishment of a bank of stored clinical bone marrow stromal cell products
BACKGROUND: Bone marrow stromal cells (BMSCs) are being used to treat a variety of conditions. For many applications a supply of cryopreserved products that can be used for acute therapy is needed. The establishment of a bank of BMSC products from healthy third party donors is described. METHODS: Th...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2012
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3309931/ https://www.ncbi.nlm.nih.gov/pubmed/22309358 http://dx.doi.org/10.1186/1479-5876-10-23 |
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author | Sabatino, Marianna Ren, Jiaqiang David-Ocampo, Virginia England, Lee McGann, Michael Tran, Minh Kuznetsov, Sergei A Khuu, Hanh Balakumaran, Arun Klein, Harvey G Robey, Pamela G Stroncek, David F |
author_facet | Sabatino, Marianna Ren, Jiaqiang David-Ocampo, Virginia England, Lee McGann, Michael Tran, Minh Kuznetsov, Sergei A Khuu, Hanh Balakumaran, Arun Klein, Harvey G Robey, Pamela G Stroncek, David F |
author_sort | Sabatino, Marianna |
collection | PubMed |
description | BACKGROUND: Bone marrow stromal cells (BMSCs) are being used to treat a variety of conditions. For many applications a supply of cryopreserved products that can be used for acute therapy is needed. The establishment of a bank of BMSC products from healthy third party donors is described. METHODS: The recruitment of healthy subjects willing to donate marrow for BMSC production and the Good Manufacturing Practices (GMP) used for assessing potential donors, collecting marrow, culturing BMSCs and BMSC cryopreservation are described. RESULTS: Seventeen subjects were enrolled in our marrow collection protocol for BMSC production. Six of the 17 subjects were found to be ineligible during the donor screening process and one became ill and their donation was cancelled. Approximately 12 ml of marrow was aspirated from one posterior iliac crest of 10 donors; one donor donated twice. The BMSCs were initially cultured in T-75 flasks and then expanded for three passages in multilayer cell factories. The final BMSC product was packaged into units of 100 × 10(6 )viable cells, cryopreserved and stored in a vapor phase liquid nitrogen tank under continuous monitoring. BMSC products meeting all lot release criteria were obtained from 8 of the 11 marrow collections. The rate of growth of the primary cultures was similar for all products except those generated from the two oldest donors. One lot did not meet the criteria for final release; its CD34 antigen expression was greater than the cut off set at 5%. The mean number of BMSC units obtained from each donor was 17 and ranged from 3 to 40. CONCLUSIONS: The production of large numbers of BMSCs from bone marrow aspirates of healthy donors is feasible, but is limited by the high number of donors that did not meet eligibility criteria and products that did not meet lot release criteria. |
format | Online Article Text |
id | pubmed-3309931 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2012 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-33099312012-03-23 The establishment of a bank of stored clinical bone marrow stromal cell products Sabatino, Marianna Ren, Jiaqiang David-Ocampo, Virginia England, Lee McGann, Michael Tran, Minh Kuznetsov, Sergei A Khuu, Hanh Balakumaran, Arun Klein, Harvey G Robey, Pamela G Stroncek, David F J Transl Med Methodology BACKGROUND: Bone marrow stromal cells (BMSCs) are being used to treat a variety of conditions. For many applications a supply of cryopreserved products that can be used for acute therapy is needed. The establishment of a bank of BMSC products from healthy third party donors is described. METHODS: The recruitment of healthy subjects willing to donate marrow for BMSC production and the Good Manufacturing Practices (GMP) used for assessing potential donors, collecting marrow, culturing BMSCs and BMSC cryopreservation are described. RESULTS: Seventeen subjects were enrolled in our marrow collection protocol for BMSC production. Six of the 17 subjects were found to be ineligible during the donor screening process and one became ill and their donation was cancelled. Approximately 12 ml of marrow was aspirated from one posterior iliac crest of 10 donors; one donor donated twice. The BMSCs were initially cultured in T-75 flasks and then expanded for three passages in multilayer cell factories. The final BMSC product was packaged into units of 100 × 10(6 )viable cells, cryopreserved and stored in a vapor phase liquid nitrogen tank under continuous monitoring. BMSC products meeting all lot release criteria were obtained from 8 of the 11 marrow collections. The rate of growth of the primary cultures was similar for all products except those generated from the two oldest donors. One lot did not meet the criteria for final release; its CD34 antigen expression was greater than the cut off set at 5%. The mean number of BMSC units obtained from each donor was 17 and ranged from 3 to 40. CONCLUSIONS: The production of large numbers of BMSCs from bone marrow aspirates of healthy donors is feasible, but is limited by the high number of donors that did not meet eligibility criteria and products that did not meet lot release criteria. BioMed Central 2012-02-06 /pmc/articles/PMC3309931/ /pubmed/22309358 http://dx.doi.org/10.1186/1479-5876-10-23 Text en Copyright ©2012 Sabatino et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Methodology Sabatino, Marianna Ren, Jiaqiang David-Ocampo, Virginia England, Lee McGann, Michael Tran, Minh Kuznetsov, Sergei A Khuu, Hanh Balakumaran, Arun Klein, Harvey G Robey, Pamela G Stroncek, David F The establishment of a bank of stored clinical bone marrow stromal cell products |
title | The establishment of a bank of stored clinical bone marrow stromal cell products |
title_full | The establishment of a bank of stored clinical bone marrow stromal cell products |
title_fullStr | The establishment of a bank of stored clinical bone marrow stromal cell products |
title_full_unstemmed | The establishment of a bank of stored clinical bone marrow stromal cell products |
title_short | The establishment of a bank of stored clinical bone marrow stromal cell products |
title_sort | establishment of a bank of stored clinical bone marrow stromal cell products |
topic | Methodology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3309931/ https://www.ncbi.nlm.nih.gov/pubmed/22309358 http://dx.doi.org/10.1186/1479-5876-10-23 |
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