Stem Cell-based Medicinal Products: Regulatory Perspectives

2016 ◽  
pp. 323-342
Author(s):  
Deniz Ozdil ◽  
Deniz Ozdil ◽  
Halil Murat Aydin
Keyword(s):  
Stem Cell ◽  
Medicinal Products

The regulatory sciences for stem cell-based medicinal products

2014 ◽  
Vol 8 (2) ◽  
pp. 190-200 ◽  
Author(s):  
Bao-Zhu Yuan ◽  
Junzhi Wang
Keyword(s):  
Stem Cell ◽  
Medicinal Products ◽  
Regulatory Sciences

scholarly journals Pluripotent stem cell based medicinal products: A case study of process transfer related technical and manufacturing issues

Cytotherapy ◽  
2017 ◽  
Vol 19 (5) ◽  
pp. S145-S146
Author(s):  
S. Sebastian ◽  
A. Chandra ◽  
P. Hourd ◽  
S. Wilson ◽  
M. McCall ◽  
...  
Keyword(s):  
Stem Cell ◽  
Pluripotent Stem Cell ◽  
Medicinal Products ◽  
Process Transfer

Regulatory viewpoints on the development of advanced stem cell–based medicinal products in light of the first EU-approved stem cell product

2015 ◽  
Vol 1 (1) ◽  
pp. 109-127 ◽  
Author(s):  
Paula Salmikangas ◽  
◽  
Egbert Flory ◽  
Paolo Gasparini ◽  
Veronika Jekerle ◽  
...  
Keyword(s):  
Stem Cell ◽  
Medicinal Products ◽  
Cell Product ◽  
Stem Cell Product

scholarly journals Overview of Cellular Immunotherapies within Transfusion Medicine for the Treatment of Malignant Diseases

2021 ◽  
Vol 22 (10) ◽  
pp. 5120
Author(s):  
Nataša Tešić ◽  
Primož Poženel ◽  
Urban Švajger
Keyword(s):  
Clinical Trials ◽  
Stem Cell ◽  
Transfusion Medicine ◽  
Malignant Diseases ◽  
Medicinal Products ◽  
Clinical Patient ◽  
Fda Approval ◽  
Advanced Therapy ◽  
Investigator Initiated Trials ◽  
High Level

Over the years, transfusion medicine has developed into a broad, multidisciplinary field that covers different clinical patient services such as apheresis technology and the development of stem cell transplantation. Recently, the discipline has found a niche in development and production of advanced therapy medicinal products (ATMPs) for immunotherapy and regenerative medicine purposes. In clinical trials, cell-based immunotherapies have shown encouraging results in the treatment of multiple cancers and autoimmune diseases. However, there are many parameters such as safety, a high level of specificity, and long-lasting efficacy that still need to be optimized to maximize the potential of cell-based immunotherapies. Thus, only a few have gained FDA approval, while the majority of them are studied in the context of investigator-initiated trials (IITs), where modern, academically oriented transfusion centers can play an important role. In this review, we summarize existing and contemporary cellular immunotherapies, which are already a part of modern transfusion medicine or are likely to become so in the future.

Use of unregulated stem-cell based medicinal products

The Lancet ◽  
2010 ◽  
Vol 376 (9740) ◽  
pp. 514 ◽  
Author(s):  
Keyword(s):  
Stem Cell ◽  
Medicinal Products

Advanced Therapy Medicinal Products for Unmet Clinical Needs: Bone Marrow-Derived Mesenchymal Stem Cell to Treat Airway Defects

Cytotherapy ◽  
2016 ◽  
Vol 18 (6) ◽  
pp. S81
Author(s):  
T. Montemurro ◽  
S. Budelli ◽  
M. Viganò ◽  
C. Lavazza ◽  
E. Montelatici ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Stem Cell ◽  
Mesenchymal Stem Cell ◽  
Medicinal Products ◽  
Advanced Therapy Medicinal Products ◽  
Advanced Therapy

Author response for "Inhibition of neural stem cell aging through the transient induction of reprogramming factors"

2020 ◽  
Author(s):  
Min Ji Han ◽  
Won Ji Lee ◽  
Joonhyuk Choi ◽  
Yean Ju Hong ◽  
Sang Jun Uhm ◽  
...  
Keyword(s):  
Stem Cell ◽  
Neural Stem Cell ◽  
Author Response ◽  
Cell Aging ◽  
Stem Cell Aging ◽  
Reprogramming Factors
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