The establishment of a bank of stored clinical bone marrow stromal cell products

Marianna Sabatino, Jiaqiang Ren, Virginia David-Ocampo, Lee England, Michael McGann, Minh Tran, Sergei A. Kuznetsov, Hanh Khuu, Arun Balakumaran, Harvey G. Klein, Pamela G. Robey, David F. Stroncek

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Article number23
JournalJournal of Translational Medicine
Volume10
Issue number1
DOIs
StatePublished - Feb 6 2012
Externally publishedYes

Fingerprint

Mesenchymal Stromal Cells
Bone
Tissue Donors
Bone Marrow
CD34 Antigens
Donor Selection
Cryopreservation
Liquid nitrogen
Healthy Volunteers
Industrial plants
Nitrogen
Screening
Multilayers
Vapors

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)
  • Medicine(all)

Cite this

Sabatino, M., Ren, J., David-Ocampo, V., England, L., McGann, M., Tran, M., ... Stroncek, D. F. (2012). The establishment of a bank of stored clinical bone marrow stromal cell products. Journal of Translational Medicine, 10(1), [23]. https://doi.org/10.1186/1479-5876-10-23

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.

In: Journal of Translational Medicine, Vol. 10, No. 1, 23, 06.02.2012.

Research output: Contribution to journalArticle

Sabatino, M, Ren, J, David-Ocampo, V, England, L, McGann, M, Tran, M, Kuznetsov, SA, Khuu, H, Balakumaran, A, Klein, HG, Robey, PG & Stroncek, DF 2012, 'The establishment of a bank of stored clinical bone marrow stromal cell products', Journal of Translational Medicine, vol. 10, no. 1, 23. https://doi.org/10.1186/1479-5876-10-23
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. In: Journal of Translational Medicine. 2012 ; Vol. 10, No. 1.
@article{e031ef6f1de94b1b9ac640ffd94683bf,
title = "The establishment of a bank of stored clinical bone marrow stromal cell products",
abstract = "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.",
author = "Marianna Sabatino and Jiaqiang Ren and Virginia David-Ocampo and Lee England and Michael McGann and Minh Tran and Kuznetsov, {Sergei A.} and Hanh Khuu and Arun Balakumaran and Klein, {Harvey G.} and Robey, {Pamela G.} and Stroncek, {David F.}",
year = "2012",
month = "2",
day = "6",
doi = "10.1186/1479-5876-10-23",
language = "English (US)",
volume = "10",
journal = "Journal of Translational Medicine",
issn = "1479-5876",
publisher = "BioMed Central",
number = "1",

}

TY - JOUR

T1 - The establishment of a bank of stored clinical bone marrow stromal cell products

AU - Sabatino, Marianna

AU - Ren, Jiaqiang

AU - David-Ocampo, Virginia

AU - England, Lee

AU - McGann, Michael

AU - Tran, Minh

AU - Kuznetsov, Sergei A.

AU - Khuu, Hanh

AU - Balakumaran, Arun

AU - Klein, Harvey G.

AU - Robey, Pamela G.

AU - Stroncek, David F.

PY - 2012/2/6

Y1 - 2012/2/6

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84856584184&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84856584184&partnerID=8YFLogxK

U2 - 10.1186/1479-5876-10-23

DO - 10.1186/1479-5876-10-23

M3 - Article

C2 - 22309358

AN - SCOPUS:84856584184

VL - 10

JO - Journal of Translational Medicine

JF - Journal of Translational Medicine

SN - 1479-5876

IS - 1

M1 - 23

ER -