Quality compliance in the shift from cell transplantation to cell therapy in non-pharma environments

Vives, Joaquim; Oliver-Vila, Irene; Pla, Arnau

doi:10.1016/j.jcyt.2015.02.002

Cited by 37 publications

(23 citation statements)

References 19 publications

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“…Currently, there are 38 clinical trials registered, with 9 in Phase 1, 16 in joint-Phase 1/2, and 8 in Phase 2. Not surprisingly, more than 18 % of studies have published results on the safety and efficacy of MSCs for OA treatment [42–46, 94]. Overall, these studies demonstrate quite positive results regarding improvement in symptomatology—including pain—and joint repair as seen by cartilage regeneration.…”

Section: State Of Msc Clinical Research In Specific Immune-/inflammatmentioning

confidence: 99%

“…The majority of trials are still ongoing, with less than 7 % of trials with published results; these published reports have been for clinical trials on MS [38], GVHD [39–41], OA [42–46], inflammatory bowel disease (IBD) [47, 48] and various pulmonary inflammatory diseases [49–51]. In this review, therefore, we will discuss the possible mechanisms and clinical efficacy of MSC treatment for these particular indications (Fig.…”

Section: Clinical Status Of Msc Therapy For Immune-/inflammation-medimentioning

confidence: 99%

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Human mesenchymal stem cells (MSCs) for treatment towards immune- and inflammation-mediated diseases: review of current clinical trials

et al. 2016

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Human mesenchymal stem cells (MSCs) are multilineage somatic progenitor/stem cells that have been shown to possess immunomodulatory properties in recent years. Initially met with much skepticism, MSC immunomodulation has now been well reproduced across tissue sources and species to be clinically relevant. This has opened up the use of these versatile cells for application as 3rd party/allogeneic use in cell replacement/tissue regeneration, as well as for immune- and inflammation-mediated disease entities. Most surprisingly, use of MSCs for in immune-/inflammation-mediated diseases appears to yield more efficacy than for regenerative medicine, since engraftment of the exogenous cell does not appear necessary. In this review, we focus on this non-traditional clinical use of a tissue-specific stem cell, and highlight important findings and trends in this exciting area of stem cell therapy.

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Section: State Of Msc Clinical Research In Specific Immune-/inflammatmentioning

confidence: 99%

Section: Clinical Status Of Msc Therapy For Immune-/inflammation-medimentioning

confidence: 99%

Human mesenchymal stem cells (MSCs) for treatment towards immune- and inflammation-mediated diseases: review of current clinical trials

et al. 2016

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“…In any case, cryopreservation will likely be required to ensure that the required tests are able to be carried out . Finally, any significant changes to the process will require these safety and efficacy tests to be repeated, and may require “upstream” testing, such as pharmacodynamic studies in large animal models of disease or pharmacokinetic dose‐optimization studies and tumor monitoring in immunodeficient mice .…”

Section: Clinical Studies Of Msc Therapymentioning

confidence: 99%

Concise Review: Mesenchymal Stem Cell Therapy for Pediatric Disease: Perspectives on Success and Potential Improvements

Nitkin

Bonfield

2016

Stem Cells Translational Medicine

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Mesenchymal stem cells (MSCs) represent a potentially revolutionary therapy for a wide variety of pediatric diseases, but the optimal cell‐based therapeutics for such diversity have not yet been specified. The published clinical trials for pediatric pulmonary, cardiac, orthopedic, endocrine, neurologic, and hematologic diseases provide evidence that MSCs are indeed efficacious, but the significant heterogeneity in therapeutic approaches between studies raises new questions. The purpose of this review is to stimulate new preclinical and clinical trials to investigate these factors. First, we discuss recent clinical trials for pediatric diseases studying MSCs obtained from bone marrow, umbilical cord and umbilical cord blood, placenta, amniotic fluid, and adipose tissue. We then identify factors, some unique to pediatrics, which must be examined to optimize therapeutic efficacy, including route of administration, dose, timing of administration, the role of ex vivo differentiation, cell culture techniques, donor factors, host factors, and the immunologic implications of allogeneic therapy. Finally, we discuss some of the practicalities of bringing cell‐based therapy into the clinic, including regulatory and manufacturing considerations. The aim of this review is to inform future studies seeking to maximize therapeutic efficacy for each disease and for each patient. Stem Cells Translational Medicine 2017;6:539–565

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“…Very often, the translation of preclinical academic research into GMP procedures has been facilitated from being conducted in blood, cell and/or tissue banks due to the availability of abundant source materials and to the familiarity with cell and tissue clinical-grade manipulation procedures, thus easily filling the gap 'from the bench to the bedside' [26]. Nevertheless, the economic effect of building and maintaining a GMP facility is significant even when ATMPs are manufactured inside a public hospital.…”

mentioning

confidence: 99%

Challenges of Running a GMP Facility for Regenerative Medicine in a Public Hospital

2017

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Advanced therapy medicinal products represent a new generation of medicinal products for regenerative medicine. Since the implementation of the EU regulation for this innovative class of drugs, the academic and hospital institutions have played a central role in their development and manufacture. For these institutions that are not familiar with the industrial context, being in compliance with the pharmaceutical standards is extremely challenging. This report describes how we dealt with some specific issues during our hospital-based GMP experience. Furthermore, we identify as a future perspective the consistent stimulating contribution that a public entity can ensure for advanced therapy medicinal product development and licensing.

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Quality compliance in the shift from cell transplantation to cell therapy in non-pharma environments

Cited by 37 publications

References 19 publications

Human mesenchymal stem cells (MSCs) for treatment towards immune- and inflammation-mediated diseases: review of current clinical trials

Human mesenchymal stem cells (MSCs) for treatment towards immune- and inflammation-mediated diseases: review of current clinical trials

Concise Review: Mesenchymal Stem Cell Therapy for Pediatric Disease: Perspectives on Success and Potential Improvements

Challenges of Running a GMP Facility for Regenerative Medicine in a Public Hospital

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