Manufacturing mesenchymal stromal cells for phase i clinical trials

Patrick J. Hanley; Zhuyong Mei; Maria Da Graca Cabreira-Hansen; Mariola Klis; Wei Li; Yali Zhao; April G. Durett; Xingwu Zheng; Yongping Wang; Adrian P. Gee; Edwin M. Horwitz

doi:10.1016/j.jcyt.2012.09.007

Manufacturing mesenchymal stromal cells for phase i clinical trials

Patrick J. Hanley
, Zhuyong Mei
, Maria Da Graca Cabreira-Hansen
, Mariola Klis
, Wei Li
, Yali Zhao
, April G. Durett
, Xingwu Zheng
, Yongping Wang
, Adrian P. Gee
, Edwin M. Horwitz

Research output: Contribution to journal › Article › peer-review

54 Scopus citations

Abstract

Mesenchymal stromal cells (MSCs) are multipotent progenitor cells capable of differentiating into adipocytes, osteoblasts and chondroblasts as well as secreting a vast array of soluble mediators. This potentially makes MSCs important mediators of a variety of therapeutic applications. They are actively under evaluation for immunomodulatory purposes such as graft-versus-host disease and Crohn's disease as well as regenerative applications such as stroke and congestive heart failure. We report our method of generating clinical-grade MSCs together with suggestions gathered from manufacturing experience in our Good Manufacturing Practices facility.

Original language	English
Pages (from-to)	416-422
Number of pages	7
Journal	Cytotherapy
Volume	15
Issue number	4
DOIs	https://doi.org/10.1016/j.jcyt.2012.09.007
State	Published - Apr 2013

Keywords

Good Manufacturing Practices
clinical trials
mesenchymal stromal cells
phase I trials

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10.1016/j.jcyt.2012.09.007

Cite this

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title = "Manufacturing mesenchymal stromal cells for phase i clinical trials",

abstract = "Mesenchymal stromal cells (MSCs) are multipotent progenitor cells capable of differentiating into adipocytes, osteoblasts and chondroblasts as well as secreting a vast array of soluble mediators. This potentially makes MSCs important mediators of a variety of therapeutic applications. They are actively under evaluation for immunomodulatory purposes such as graft-versus-host disease and Crohn's disease as well as regenerative applications such as stroke and congestive heart failure. We report our method of generating clinical-grade MSCs together with suggestions gathered from manufacturing experience in our Good Manufacturing Practices facility.",

keywords = "Good Manufacturing Practices, clinical trials, mesenchymal stromal cells, phase I trials",

author = "Hanley, \{Patrick J.\} and Zhuyong Mei and \{Da Graca Cabreira-Hansen\}, Maria and Mariola Klis and Wei Li and Yali Zhao and Durett, \{April G.\} and Xingwu Zheng and Yongping Wang and Gee, \{Adrian P.\} and Horwitz, \{Edwin M.\}",

note = "Funding Information: This project is supported by the National Heart, Lung and Blood Institute–National Institutes of Health Production Assistance for Cellular Therapy (PACT) program, contract No. HHSN268201000007C . The authors also thank Keli Sharpe for her technical expertise in flow cytometry, Sara Richman for her meticulous reading of the manuscript and Drs Catherine Bollard, Malcolm Brenner and Helen Heslop for their support and guidance. ",

year = "2013",

month = apr,

doi = "10.1016/j.jcyt.2012.09.007",

language = "English",

volume = "15",

pages = "416--422",

journal = "Cytotherapy",

issn = "1465-3249",

number = "4",

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TY - JOUR

T1 - Manufacturing mesenchymal stromal cells for phase i clinical trials

AU - Hanley, Patrick J.

AU - Mei, Zhuyong

AU - Da Graca Cabreira-Hansen, Maria

AU - Klis, Mariola

AU - Li, Wei

AU - Zhao, Yali

AU - Durett, April G.

AU - Zheng, Xingwu

AU - Wang, Yongping

AU - Gee, Adrian P.

AU - Horwitz, Edwin M.

N1 - Funding Information: This project is supported by the National Heart, Lung and Blood Institute–National Institutes of Health Production Assistance for Cellular Therapy (PACT) program, contract No. HHSN268201000007C . The authors also thank Keli Sharpe for her technical expertise in flow cytometry, Sara Richman for her meticulous reading of the manuscript and Drs Catherine Bollard, Malcolm Brenner and Helen Heslop for their support and guidance.

PY - 2013/4

Y1 - 2013/4

N2 - Mesenchymal stromal cells (MSCs) are multipotent progenitor cells capable of differentiating into adipocytes, osteoblasts and chondroblasts as well as secreting a vast array of soluble mediators. This potentially makes MSCs important mediators of a variety of therapeutic applications. They are actively under evaluation for immunomodulatory purposes such as graft-versus-host disease and Crohn's disease as well as regenerative applications such as stroke and congestive heart failure. We report our method of generating clinical-grade MSCs together with suggestions gathered from manufacturing experience in our Good Manufacturing Practices facility.

AB - Mesenchymal stromal cells (MSCs) are multipotent progenitor cells capable of differentiating into adipocytes, osteoblasts and chondroblasts as well as secreting a vast array of soluble mediators. This potentially makes MSCs important mediators of a variety of therapeutic applications. They are actively under evaluation for immunomodulatory purposes such as graft-versus-host disease and Crohn's disease as well as regenerative applications such as stroke and congestive heart failure. We report our method of generating clinical-grade MSCs together with suggestions gathered from manufacturing experience in our Good Manufacturing Practices facility.

KW - Good Manufacturing Practices

KW - clinical trials

KW - mesenchymal stromal cells

KW - phase I trials

UR - https://www.scopus.com/pages/publications/84875719380

U2 - 10.1016/j.jcyt.2012.09.007

DO - 10.1016/j.jcyt.2012.09.007

M3 - Article

C2 - 23480951

AN - SCOPUS:84875719380

SN - 1465-3249

VL - 15

SP - 416

EP - 422

JO - Cytotherapy

JF - Cytotherapy

IS - 4

ER -

Manufacturing mesenchymal stromal cells for phase i clinical trials

Abstract

Keywords

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