First Approval of Regenerative Medical Products under the PMD Act in Japan

Konishi, Akihide; Sakushima, Ken; Isobe, Soichiro; Sato, Daisaku

doi:10.1016/j.stem.2016.03.011

Cited by 37 publications

(27 citation statements)

References 4 publications

(4 reference statements)

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“…Indeed, one of the main and critical obstacles is the final costs of these products. Several facilitating strategies have been recently developed in different European and non-European countries to facilitate access to the market (such as the adaptive framework for the approval of regenerative medical products under the Pharmaceuticals, Medical Devices and Other Therapeutic Products Act in Japan, the conditional marketing authorization in Europe, and the US FDA-accelerated approval in the USA) [31][32][33][34][35]. However, these approaches have no yet direct effect on academic facilities that still rely on the acquisition of public and private funds on a competitive basis.…”

Section: To Spin Offmentioning

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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Section: To Spin Offmentioning

confidence: 99%

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

2017

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“…Now, several countries are using Prochymal TM to manage GVHD (Chen et al, 2014;Kurtzberg et al, 2014;Prasad et al, 2011). Recently, another form of MSCs was approved in Japan for GVHD (Konishi et al, 2016).…”

Section: Introductionmentioning

confidence: 99%

Umbilical cord-derived stem cells (ModulatistTM) show strong immunomodulation capacity compared to adipose tissue-derived or bone marrow-derived mesenchymal stem cells

Pham¹,

Vu²,

Phan³

2016

Biomed Res Ther

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Abstract-Introduction:Mesenchymal stem cells (MSCs) show great promise in regenerative medicine. Clinical applications of MSCs have recently increased significantly, especially for immune diseases. Autologous transplantation is considered a safe therapy. However, its main disadvantages are poor stability and quality of MSCs from patient to patient, and labor-intensive and time-consuming culture procedures. Therefore, allogeneic MSC transplantation has recently emerged as a potential replacement for autologous transplantation. "Off the shelf" MSC products, or socalled "stem cell drugs", have rapidly developed; these products have already been approved in various countries, including Canada, Korea and Japan. This study aims to evaluate a new stem cell product or "drug", termed Modulatist TM , derived from umbilical cord mesenchymal stem cells (UCMSCs), which have strong immunomodulatory properties, compared to bone marrow-derived MSCs (BMMSCs) or adipose tissue-derived stem cells (ADSCs). Methods: Modulatist TM was produced from MSCs derived from whole umbilical cord (UC) tissue (which includes Wharton's jelly and UC), according to GMP compliant procedures. Bone marrow-and adipose tissue-derived MSCs were isolated and proliferated in standard conditions, according to GMP compliant procedures. Immunomodulation mediated by MSCs was assessed by allogenic T cell suppression and cytokine release; role of prostaglandin E2 in the immunomodulation was also evaluated. Results: The results showed that Modulatist TM exhibited stronger immunomodulation than BMMSC and ADSC in vitro. Modulatist TM strongly suppressed allogeneic T cells proliferation and decreased cytokine production, compared to BMMSCs and ADSCs. Conclusion: Modulatist TM is a strong immunomodulator and promising MSC product. It may be useful to modulate or treat autoimmune diseases.

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“…Nishimura, Masuhiro et al discuss the use of clinical grade neonatal porcine bone marrow‐derived mesenchymal stem cells (npBM‐MSCs) in leu of human bone marrow‐derived MSCs (hBM‐MSC). HBM‐MSCs are useful but have inadequate donor availability for human tissue MSC‐derived therapeutics like TEMCELL® HS Inj . MSCs in general, isolated from bone marrow, adipose, or umbilical cord tissues, can be easily characterized given they adhere to plastic culture plates, grow and form colonies, express cell surface markers (CD29, CD44, and CD90), and can be stimulated in vitro to differentiate into osteoblasts, adipocytes, and chondrocytes .…”

Section: Clinical Grade Neonatal Porcine Bone Marrow‐derived Mesenchymentioning

confidence: 99%

Xenotransplantation literature update, May/June 2019

Forneris

Burlak

2019

Xenotransplantation

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First Approval of Regenerative Medical Products under the PMD Act in Japan

Cited by 37 publications

References 4 publications

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

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

Umbilical cord-derived stem cells (ModulatistTM) show strong immunomodulation capacity compared to adipose tissue-derived or bone marrow-derived mesenchymal stem cells

Xenotransplantation literature update, May/June 2019

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