Good manufacturing practice-compliant validation and preparation of BM cells for the therapy of acute myocardial infarction

Griesel, C; Hg, Heuft; Herrmann, David N.; Franke, Astrid; Ladas, Dimitrios S; Stiehler, N; Stucki, Andreas; Braun, Maike; Wollert, KC; Meyer, Geerd J.; Drexler, Helmut; Hertenstein, Bernd; Ganser, Arnold; Rüdinger, W; Arseniev, Lubomir

doi:10.1080/14653240601052734

Cited by 15 publications

(7 citation statements)

References 24 publications

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“…In humans, several studies indicate improvement in cardiac function when autologous bone marrow or peripheral stem cell is administered directly into damaged myocardium. But these studies did not explain whether improved outcomes were result from generation of HSC derived myocytes or were secondary effects or due to paracrine signaling [145-149]. Apart from the major organ regeneration potential, it was also found that HSC could be transdifferentiated into endothelial and epithelial cell lineages after HSCT [150].…”

Section: Non-hematopoietic Differentiation Of Hscmentioning

confidence: 99%

Plasticity and Maintenance of Hematopoietic Stem Cells During Development

Sugita

Pompili²,

Das

2011

BIOT

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Maintenance of hematopoietic stem cells (HSCs) pool depends on fine balance between self-renewal and differentiation of HSCs. HSCs normally reside within the bone marrow niche of an adult mammal. The embryonic development of HSCs is a complex process that involves the migration of developing HSCs in multiple anatomical sites. Throughout the process, developing HSCs receive internal (transcriptional program) and external (HSC niche) signals, which direct them to maintain balance between self-renewal and differentiation, also to generate a pool of HSCs. In physiological condition HSCs differentiate into all mature cell types present in the blood. However, in pathological condition they may differentiate into non-hematological cells according to the need of the body. It was shown that HSCs can transdifferentiate into cell types that do not belong to the hematopoietic system suggests a complete paradigm shift of the hierarchical hematopoietic tree. This review describes the developmental origins and regulation of HSCs focusing on developmental signals that induce the adult hematopoietic stem cell program, as these informations are very critical for manipulating conditions for expansion of HSCs in ex vivo condition. This review also states clinical application and related patents using HSC.

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Section: Non-hematopoietic Differentiation Of Hscmentioning

confidence: 99%

Plasticity and Maintenance of Hematopoietic Stem Cells During Development

Sugita

Pompili²,

Das

2011

BIOT

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“…In addition, the discrepancies in the results of the different trials may be partially ascribed to variations in the variables in each trial, such as the number of cells injected, the cell preparations, the delivery procedures, and even the baseline extent of LV dysfunction and geometry of the patients. Therefore, a good manufacturing practice (GMP) process is indispensable to warrant the production of a quality-controlled cell product and prevent contaminations of the end product [ 73 ]. With regard to safety, autologous BMCs are still the most frequently used cell type for the treatment of acute MI because among all the clinical trials that have been conducted there have been no observations of carcinogenesis, arrhythmias, or any other adverse effects [ 74 ].…”

Section: Types Of Stem Cells For Cardiac Cell Therapymentioning

confidence: 99%

Cell Therapies in Cardiomyopathy: Current Status of Clinical Trials

Hao

Wang

2017

Analytical Cellular Pathology

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Because the human heart has limited potential for regeneration, the loss of cardiomyocytes during cardiac myopathy and ischaemic injury can result in heart failure and death. Stem cell therapy has emerged as a promising strategy for the treatment of dead myocardium, directly or indirectly, and seems to offer functional benefits to patients. The ideal candidate donor cell for myocardial reconstitution is a stem-like cell that can be easily obtained, has a robust proliferation capacity and a low risk of tumour formation and immune rejection, differentiates into functionally normal cardiomyocytes, and is suitable for minimally invasive clinical transplantation. The ultimate goal of cardiac repair is to regenerate functionally viable myocardium after myocardial infarction (MI) to prevent or heal heart failure. This review provides a comprehensive overview of treatment with stem-like cells in preclinical and clinical studies to assess the feasibility and efficacy of this novel therapeutic strategy in ischaemic cardiomyopathy.

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“…The hiBMC group was designed to match the BMC group in BOOST. Nucleated BMCs were prepared by gelatine-polysuccinate density gradient sedimentation using the original protocol from the BOOST trial. 6,22 To prepare irradiated BMCs, the bone marrow sample was c-irradiated prior to the sedimentation process. The placebo product was prepared from a peripheral blood sample and designed as a pure red blood cell suspension that was indistinguishable from the BMC products in terms of Intracoronary autologous bone marrow cell transfer after myocardial infarction…”

Section: Methodsmentioning

confidence: 99%