Large‐Scale Production of Adult Stem Cells for Clinical Use

Goltry, Kristin L.; Hampson, Brian; Venturi, Naia A.; Bartel, Ronnda L.

doi:10.1002/9780470454923.ch9

Cited by 5 publications

(1 citation statement)

References 24 publications

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“…Ixmyelocel-T is shipped overnight to the treatment site using a qualified gel-packed shipping container that maintains the product at hypothermic temperature; in this container the product has a 72-hour shelf life. Components of the manufacturing system are pictured in Figure 1[8]. …”

Section: Manufacturingmentioning

confidence: 99%

The Aastrom experience

et al. 2012

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Aastrom Biosciences has developed a proprietary cell-processing technology that enables the manufacture of ixmyelocel-T, a patient-specific multicellular therapy expanded from a small sample of a patient's own bone marrow. Ixmyelocel-T is produced under current good manufacturing practices (cGMP) in a fully closed, automated system that expands mesenchymal stem cells (MSCs) and macrophages. While the cell types in ixmyelocel-T are the same as those found in the bone marrow, the numbers of MSCs and alternative macrophages are greater in ixmyelocel-T. We propose that the mixture of expanded MSCs and alternatively activated macrophages promote long-term tissue repair of ischemic tissue. The multiple cell types in ixmyelocel-T have a range of biological activities that are likely to contribute to a complex mechanism of action. Clinical trial data collected to date support the potential for ixmyelocel-T as an efficacious and safe treatment for ischemic cardiovascular indications, including critical limb ischemia (CLI) and a severe form of heart failure, dilated cardiomyopathy (DCM). The CLI clinical program has completed phase 2 and has reached concurrence with the Food and Drug Administration (FDA) on a phase 3 study (REVIVE) through the Special Protocol Assessment (SPA) process. The phase 3 study began screening patients in February 2012. The DCM clinical program will initiate phase 2b in 2012.

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Section: Manufacturingmentioning

confidence: 99%

The Aastrom experience

et al. 2012

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Bioreactors in Tissue Engineering

Obregón

Ramón‐Azcón

Ahadian

2017

Tissue Engineering for Artificial Organs

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Bioreactor design for clinical‐grade expansion of stem cells

Santos

Andrade

Silva

et al. 2013

Biotechnology Journal

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The many clinical trials currently in progress will likely lead to the widespread use of stem cell-based therapies for an extensive variety of diseases, either in autologous or allogeneic settings. With the current pace of progress, in a few years' time, the field of stem cell-based therapy should be able to respond to the market demand for safe, robust and clinically efficient stem cell-based therapeutics. Due to the limited number of stem cells that can be obtained from a single donor, one of the major challenges on the roadmap for regulatory approval of such medicinal products is the expansion of stem cells using Good Manufacturing Practices (GMP)-compliant culture systems. In fact, manufacturing costs, which include production and quality control procedures, may be the main hurdle for developing cost-effective stem cell therapies. Bioreactors provide a viable alternative to the traditional static culture systems in that bioreactors provide the required scalability, incorporate monitoring and control tools, and possess the operational flexibility to be adapted to the differing requirements imposed by various clinical applications. Bioreactor systems face a number of issues when incorporated into stem cell expansion protocols, both during development at the research level and when bioreactors are used in on-going clinical trials. This review provides an overview of the issues that must be confronted during the development of GMP-compliant bioreactors systems used to support the various clinical applications employing stem cells.

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Large‐Scale Production of Adult Stem Cells for Clinical Use

Cited by 5 publications

References 24 publications

The Aastrom experience

The Aastrom experience

Bioreactors in Tissue Engineering

Bioreactor design for clinical‐grade expansion of stem cells

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