Randomized clinical trials for hematopoietic stem cell transplantation: lessons to be learned from the European experience

Kuthiala, S S; Lyman, Gary H.; Ballester, Oscar F.

doi:10.1038/sj.bmt.1705230

Cited by 4 publications

(3 citation statements)

References 18 publications

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“…They have been used in several pre-clinical models of disease (1–3) and are currently being used in phase I–III clinical trials (4–7). Neural stem cells (NSCs) can differentiate into neuronal or glial cells and express trophic factors to rescue dysfunctional brain tissue (8–12).…”

Section: Introductionmentioning

confidence: 99%

Magnetic Resonance Imaging Detects Differences in Migration Between Primary and Immortalized Neural Stem Cells

et al. 2008

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Rationale and Objectives-The study was performed to evaluate the effect of MRI contrast agent (super paramagnetic iron oxide (SPIO)) on differentiation and migration of primary murine neural stem cells (NSCs) in comparison to a neural stem cell line (C17.2). Since detection of labeled cells depends on the concentration of SPIO particles per imaging voxel, the study was performed at various concentrations of SPIO particles to determine the concentration that could be used for in vivo detection of small clusters of grafted cells.Materials and Methods-Murine primary NSCs or C17.2 cells were labeled with different concentrations of SPIO particles (0, 25, 100 and 250 μg Fe/ml) and in vitro assays were performed to assess cell differentiation. In vivo MRI was performed seven weeks after neonatal transplantation of labeled cells to evaluate the difference in migration capability of the two cell populations.Results-Both the primary NSC's and the C17.2 cells differentiated to similar number of neurons (Map2ab positive cells). Similar patterns of engraftment of C17. 2 cells were seen in transplanted mice regardless of the SPIO concentration used. In vivo MRI detection of grafted primary and C17.2 cells was only possible when cells were incubated with 100 μg/ml or higher concentration of SPIO. Extensive migration of C17.2 cells throughout the brain was observed, while the migration of the primary NSCs was more restricted.Conclusion-Engraftment of primary NSC's can be detected non-invasively by in vivo MRI and the presence of SPIO particles do not affect the viability, differentiation or engraftment pattern of the donor cells.

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Section: Introductionmentioning

confidence: 99%

Magnetic Resonance Imaging Detects Differences in Migration Between Primary and Immortalized Neural Stem Cells

et al. 2008

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“…Indeed, the American Society for Blood and Marrow Transplantation recognized the paucity of RCTs addressing aspects of allogeneic HSCT and established the Clinical Trials Network in 2001 (www.bmtctn.net) and have initiated 32 clinical trials since its inception (Christopher N. Bredeson, personal communication). Kuthiala et al [20] hypothesized that RCTs in allogeneic HSCT may be limited by the significant reliance on the pharmaceutical industry to sponsor clinical research on interventional strategies. Many aspects of care in allogeneic HSCT may be less amenable to strategies that will lead to new drug approval, limiting interest from industry partners.…”

Section: Discussionmentioning

confidence: 99%

Current Trends in Clinical Studies of Allogeneic Hematopoietic Stem Cell Transplantation

Pilon

Jedrysiak

Sheppard

et al. 2015

Biology of Blood and Marrow Transplantation

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Allogeneic hematopoietic stem cell transplantation (HSCT) is a specialized intervention performed at select centers worldwide. The extent to which specific aspects of care in allogeneic HSCT have been studied and the types of studies performed for different aspects of care remains incompletely documented. Studies in allogeneic HSCT were systematically identified from selected high-profile transplant journals between July 2010 and June 2011 and previously reported in a study addressing the definition of clinical outcomes in HSCT. All articles were retrieved and assessed for study characteristics and categorized by specific aspects of care related to allogeneic HSCT. One hundred sixteen articles were retrieved and reviewed in detail by 2 investigators. The most studied aspect of care was conditioning regimens. Transfusion practices were the most understudied aspect of care. Interestingly, most studies included both adult and pediatric patients. Studies involving all hematological malignancies were encountered more often than disease-specific studies. Geographically, most patients described in the published reports were treated only in North America or only in Europe. Most studies were retrospective (78), and 25 reported on multicenter registry data. Of the 38 prospective studies, 8 were randomized controlled trials (RCTs) and predominantly focused on prevention and treatment of graft-versus-host disease (GVHD) and infections. Median follow-up was longer in retrospective registry studies (54 months) and shortest in RCTs (32 months). The proportion of positive outcomes in retrospective and prospective studies was remarkably high (>80% for all categories) and not significantly different across all aspects of care (P > .05). When comparing RCTs and registry data studies, this proportion was similar and high (95% and 100%, respectively, P > .05). Our study highlights the established and important role of retrospective registry studies for many aspects of care and suggests RCTs may be most relevant for studies on infectious complications and GVHD.

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“…Stem cells have been used in several pre-clinical models of disease [47]- [49], and are currently applied in clinical trials of phase I-III [50]- [53]. For example, neuronal stem cells (NSC) can differentiate into neuronal or glial cells and also express trophic factors, which may be used to rescue dysfunction brain tissue [54]- [58].…”

Section: Discussionmentioning

confidence: 99%

A Preliminary Study on Magnetic Fields Effects on Stem Cell Differentiation

Miskon

Uslama

2011

IFMBE Proceedings

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Abstract-The objective of this paper is to provide the fundamental mathematical formula to predict the effect of magnetic fields (MF) on stem cell differentiation. The data were reviewed from journals related to the effects of magnetic fields on stem cell differentiation. These data were given a value for differentiation which is related to their MF strength with these conditions; MF strength that does not affect the stem cell differentiation given the value of zero, MF strength that results in stem cells death given the value of 1, and the MF strength that affects stem cells The differentiation given the value between 0.1 and 0.9. graph was plotted according to these data and the mathematical equation is designed from the graph. From this review, we suggest that the intensity of MF that can affect the stem cell differentiation is between 600µT and 9.4T in which the cell differentiation will not occur with intensity of less than 10µT and intensity of more than 12T will cause the death of stem cells. We also suggest that the limit of MF effects on stem cell differentiation lies between 10 µT and 600 µT, and the limit of MF strength that can lead to the death of stem cells lies between 9.4 T and 12 T. It can be concluded that the exposure of MF on stem cell differentiation depends not only on the MF intensity, but also on the period of exposure.

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Randomized clinical trials for hematopoietic stem cell transplantation: lessons to be learned from the European experience

Cited by 4 publications

References 18 publications

Magnetic Resonance Imaging Detects Differences in Migration Between Primary and Immortalized Neural Stem Cells

Magnetic Resonance Imaging Detects Differences in Migration Between Primary and Immortalized Neural Stem Cells

Current Trends in Clinical Studies of Allogeneic Hematopoietic Stem Cell Transplantation

A Preliminary Study on Magnetic Fields Effects on Stem Cell Differentiation

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