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1. Full Text Preclinical assessment of a stem cell therapeutic medicinal product for clinical application in colorectal cancer
by Lopez Navas, L and Aguado Dominguez, E and Antúnez, C and Campos, R and Lomas, I and Sella, S and de Araujo-Farias, V and Tovar, I and Rico, L and Ruiz-de Almodovar, J and Sanchez-Pernaute, R
Cytotherapy, ISSN 1465-3249, 2017, Volume 19, Issue 5, pp. S225 - S225
Advanced Basic Science | Other
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2. Full Text Detection of the relatively slow-growing Propionibacterium acnes in seven matrices of blood components and advanced therapeutical medicinal products
by Arlt, Nicole and Rothe, Remo and Juretzek, Thomas and Peltroche, Heidrun and Tonn, Torsten and Moog, Rainer
Transfusion and Apheresis Science, ISSN 1473-0502, 2017, Volume 56, Issue 3, pp. 461 - 465
Abstract Background Relatively slow-growing bacteria like Propionibacterium acnes represent a challenge for quality control investigations in sterility release... 
Hematology, Oncology and Palliative Medicine | Slow-growing bacteria | Advanced therapeutical medicinal products | Microbiological safety | Quality control | Stem cells | BACTERIAL-CONTAMINATION | SAFETY | PLATELETS | MICROBIAL-CONTAMINATION | HEMATOLOGY | HEMATOPOIETIC PROGENITOR | TRANSPLANTATION | Microbiological Techniques - methods | Chemistry, Pharmaceutical - methods | Humans | Propionibacterium acnes - isolation & purification | Bacteria - pathogenicity | Microbiological Techniques - instrumentation | Quality Control | Killer cells | Microbiology | Acne | Detectors | Bacteria | Product introduction | Blood donors
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3. Full Text Regulatory considerations for gene therapy products in the US, EU, and Japan
by Halioua-Haubold, Celine-Lea and Peyer, James G and Smith, James A and Arshad, Zeeshaan and Scholz, Matthew and Brindley, David A and Maclaren, Robert E
Yale Journal of Biology and Medicine, ISSN 0044-0086, 12/2017, Volume 90, Issue 4, pp. 683 - 693
Developers of gene therapy products (GTPs) must adhere to additional regulation beyond that of traditional small-molecule therapeutics, due to the unique... 
FDA | MHLW | Japan | ATMP | EMA | Regulation | Gene therapy | Advanced therapeutic medicinal product
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4. Full Text Manufacturing human mesenchymal stem cells at clinical scale: process and regulatory challenges
by Jossen, Valentin and van den Bos, Christian and Eibl, Regine and Eibl, Dieter
Applied Microbiology and Biotechnology, ISSN 0175-7598, 5/2018, Volume 102, Issue 9, pp. 3981 - 3994
Human mesenchymal stem cell (hMSC)-based therapies are of increasing interest in the field of regenerative medicine. As economic considerations have shown,... 
Life Sciences | Allogeneic | Biotechnology | Good manufacturing practice | Microbiology | Single-use devices | Microbial Genetics and Genomics | Human mesenchymal stem cells | Microcarrier | Advanced therapeutic medicinal product | INTERNATIONAL-SOCIETY | BONE-MARROW | OSTEOGENIC DIFFERENTIATION | THERAPY BIOPROCESS ECONOMICS | PROLIFERATION | CULTURE | FETAL BOVINE SERUM | BIOTECHNOLOGY & APPLIED MICROBIOLOGY | EXPANSION | STROMAL CELLS | HUMAN PLATELET LYSATE | Cell Culture Techniques - instrumentation | Bioreactors | Humans | Mesenchymal Stem Cells - cytology | Cell- and Tissue-Based Therapy - instrumentation | Cell- and Tissue-Based Therapy - trends | Technology Assessment, Biomedical | Production processes | Stem cells | Health care | Regeneration | Detachment | Mesenchyme | Economic theory | Cultivation | Harvesting | Equipment costs | Regulation | Regeneration (physiology) | Mini-Review
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5. Full Text Technology forecast: advanced therapies in late clinical research, EMA approval or clinical application via hospital exemption
by Eder, Claudia and Wild, Claudia
Journal of Market Access & Health Policy, ISSN 2001-6689, 01/2019, Volume 7, Issue 1, p. 1600939
Background: The umbrella term ATMPs (Advanced Therapy Medicinal Products) comprises cell therapies, gene therapeutics and tissue engineered products. After... 
phase III clinical trial | ATMP | Hospital exemption | Advanced Therapeutic Medicinal Product | marketing authorisation | hospital exemption | atmp | advanced therapeutic medicinal product | phase iii clinical trial
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6. Full Text Utility of routine evaluation of sterility of cellular therapy products with or without extensive manipulation: Best practices and clinical significance
by Golay, Josee and Pedrini, Olga and Capelli, Chiara and Gotti, Elisa and Borleri, Gianmaria and Magri, Mara and Vailati, Francesca and Passera, Marco and Farina, Claudio and Rambaldi, Alessandro and Introna, Martino
Cytotherapy, ISSN 1465-3249, 02/2018, Volume 20, Issue 2, pp. 262 - 270
We analyzed the results of routine sterility testing performed in our center over the last 10 years, in the context both hematopoietic stem cell... 
hematopoietic stem cell transplantation | microbial contamination | cost analysis | advanced therapeutic medicinal products | MEDICINE, RESEARCH & EXPERIMENTAL | GRAFTS | BONE-MARROW | MICROBIAL-CONTAMINATION | HEMATOPOIETIC PROGENITOR | GENTAMICIN | TRANSPLANTATION | CELL & TISSUE ENGINEERING | CELL BIOLOGY | MESENCHYMAL STROMAL CELLS | BIOTECHNOLOGY & APPLIED MICROBIOLOGY | HEMATOLOGY | PHASE-I | INDUCED KILLER-CELLS | HUMAN PLATELET LYSATE | Cell- and Tissue-Based Therapy - methods | Sterilization - methods | Time Factors | Culture Media | Hematopoietic Stem Cells - cytology | Humans | Mesenchymal Stem Cells - cytology | Hematopoietic Stem Cell Transplantation | Blood Component Removal | Sterilization - economics
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7. Full Text Predictors of Mononuclear Cell Yield in Patients Undergoing Autologous Mononuclear Stem Cell Therapy in Non-haemopoietic Degenerative Disorders
by Pahwa, Deepak and Pahwa, Deepak and Sharma, Ratti Ram and Sharma, Ratti Ram and Marwaha, Neelam and Marwaha, Neelam
Indian Journal of Hematology and Blood Transfusion, ISSN 0971-4502, 4/2018, Volume 34, Issue 2, pp. 282 - 293
Cellular therapy outcomes are influenced by cellular composition of the product. We analyzed the cellular profiles (TNC, MNC and CD34+ cells) of patients... 
Human Genetics | Advanced medicinal therapeutic products | Medicine & Public Health | Hematology | Oncology | Bone marrow cellular profiles | Blood Transfusion Medicine | Autologous bone marrow mononuclear cell therapy | DONORS | HEMATOLOGY | BMI | Transplantation | Analysis | Stem cells | College graduates | Body mass index | Transplants & implants | Vein & artery diseases | Gender | Trauma | Age | Clinical outcomes | Chronic illnesses | Original
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8. Full Text Development of a cell-based medicinal product: Regulatory structures in the European Union
by Gálvez, Patricia and Clares, Beatriz and Hmadcha, Abdelkrim and Ruiz, Adolfina and Soria, Bernat
British Medical Bulletin, ISSN 0007-1420, 03/2013, Volume 105, Issue 1, pp. 85 - 105
New therapies with genes, tissues and cells have taken the emerging field for the treatment of many diseases. Advances on stem cell therapy research have led... 
advanced therapies | regulatory agencies | cell therapy | UNITED-STATES | BETA-CELLS | MESENCHYMAL STEM-CELLS | CHALLENGES | PRINCIPLES | GOOD LABORATORY PRACTICE | TRANSPLANTATION | MEDICINE, GENERAL & INTERNAL | THERAPY | CLINICAL-TRIALS | PERSPECTIVES | Medicine | Consumer Product Safety - legislation & jurisprudence | European Union | Legislation, Drug | Humans | Cell- and Tissue-Based Therapy - utilization | Chronic Disease - therapy | Consumer Product Safety - standards | Public Health - legislation & jurisprudence
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9. Full Text Cord blood–derived cytokine-induced killer cells combined with blinatumomab as a therapeutic strategy for CD19+ tumors
by GOLAY, JOSÉE and MARTINELLI, SIMONA and ALZANI, RACHELE and CRIBIOLI, SABRINA and ALBANESE, CLARA and GOTTI, ELISA and PASINI, BRUNA and MAZZANTI, BENEDETTA and SACCARDI, RICCARDO and RAMBALDI, ALESSANDRO and INTRONA, MARTINO
Cytotherapy, ISSN 1465-3249, 2018, Volume 20, Issue 8, pp. 1077 - 1088
Highlights • CIKs for adoptive therapy are readily expanded from cryopreserved CBUs. • CIKs combined with blinatumomab are an effective treatment for CD19+... 
Advanced Basic Science | Other | T lymphocytes | bispecific antibody | adoptive therapy | cord blood | cytokine-induced killer | BISPECIFIC ANTIBODIES | MEDICINE, RESEARCH & EXPERIMENTAL | CIK CELLS | ANTITUMOR-ACTIVITY | TRANSPLANTATION | CELL & TISSUE ENGINEERING | CELL BIOLOGY | INTERFERON-ALPHA | BIOTECHNOLOGY & APPLIED MICROBIOLOGY | ACUTE LYMPHOBLASTIC-LEUKEMIA | IN-VIVO | HEMATOLOGICAL MALIGNANCIES | HEMATOLOGY | T-CELLS | ADOPTIVE IMMUNOTHERAPY
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10. Full Text European regulation for therapeutic use of stem cells
by Ferry, N
BIO-MEDICAL MATERIALS AND ENGINEERING, ISSN 0959-2989, 2017, Volume 28, Issue s1, pp. S3 - S7
The regulation for the use of stem cells has evolved during the past decade with the aim of ensuring a high standard of quality and safety for human derived... 
European regulation | tissue engineering | MATERIALS SCIENCE, BIOMATERIALS | somatic cell therapy | ENGINEERING, BIOMEDICAL | Advanced Therapy Medicinal Products (ATMP) | Stem Cells - classification | Cell- and Tissue-Based Therapy - standards | European Union | Stem Cell Transplantation - standards | Tissue Engineering - standards | Europe | Humans | Clinical Trials as Topic | Stem Cells - cytology | Stem Cell Transplantation - legislation & jurisprudence | Legislation, Medical - standards | Quality Control | Regulations | Regulation | Product safety | Therapeutic applications | Stem cells
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11. Full Text Addressing Pressing Needs in the Development of Advanced Therapies
by Morrow, D and Ussi, A and Migliaccio, G
FRONTIERS IN BIOENGINEERING AND BIOTECHNOLOGY, ISSN 2296-4185, 09/2017, Volume 5, p. 55
The commercial development of advanced therapy medicinal products (ATMPs) represents great opportunity for therapeutic innovation but is beset by many... 
MULTIDISCIPLINARY SCIENCES | Analysis | Therapeutics | Innovations | Homeopathy | Materia medica and therapeutics | manufacturing technology | regulatory pathway | funding models | reimbursement mechanisms | advanced therapy medicinal product
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12. Regulation of cell-based therapeutic products intended for human applications in the EU
by Närhi, Marko O and Nordström, Katrina
Regenerative Medicine, ISSN 1746-0751, 2014, Volume 9, Issue 3, pp. 327 - 351
Aims: Recent developments in the field of cell-based therapeutic products (CBTPs) have forced the EU to revise its legislation on therapeutic products by... 
Advanced therapy medicinal products | Regulation | Regulatory burden | Tissues | Blood | Cells | regulatory burden | tissues | VIVO | ENGINEERING, BIOMEDICAL | TISSUE | GRAFT | FUTURE | TRANSFUSION MEDICINE | blood | TRANSPLANTATION | CELL & TISSUE ENGINEERING | REPAIR | cells | regulation | advanced therapy medicinal products | REGENERATIVE MEDICINE | BONE | Blood Component Transfusion - legislation & jurisprudence | Models, Theoretical | Cell- and Tissue-Based Therapy - methods | Cell- and Tissue-Based Therapy - classification | European Union | Humans | Government Regulation | Regenerative Medicine - legislation & jurisprudence | Regenerative Medicine - methods
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13. Full Text Good Manufacturing Practices (GMP) manufacturing of advanced therapy medicinal products: a novel tailored model for optimizing performance and estimating costs
by Abou-El-Enein, Mohamed and Römhild, Andy and Kaiser, Daniel and Beier, Carola and Bauer, Gerhard and Volk, Hans-Dieter and Reinke, Petra
Cytotherapy, ISSN 1465-3249, 2013, Volume 15, Issue 3, pp. 362 - 383
Abstract Background aims Advanced therapy medicinal products (ATMP) have gained considerable attention in academia due to their therapeutic potential. Good... 
Advanced Basic Science | Other | advanced therapy medicinal products | clean-room technology | performance optimization | micro-costing | Good Manufacturing Practices | Advanced therapy medicinal products | Performance optimization | Clean-room technology | Good manufacturing practices | Micro-costing | MEDICINE, RESEARCH & EXPERIMENTAL | TRANSLATION | CHALLENGES | CELL & TISSUE ENGINEERING | CELL BIOLOGY | ECONOMIC-EVALUATION | IMMUNOTHERAPY | BIOTECHNOLOGY & APPLIED MICROBIOLOGY | CLINICAL-TRIALS | GENE-THERAPY | HEMATOLOGY | BUSINESS MODEL | CELL | Commerce - economics | United States | Cell- and Tissue-Based Therapy - economics | Cost-Benefit Analysis | Humans | Germany
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14. Full Text Natural products: An evolving role in future drug discovery
by Mishra, Bhuwan B and Tiwari, Vinod K
European Journal of Medicinal Chemistry, ISSN 0223-5234, 2011, Volume 46, Issue 10, pp. 4769 - 4807
The therapeutic areas of infectious diseases and oncology have benefited from abundant scaffold diversity in natural products, able to interact with many... 
Drug discovery | Natural products | Clinical development | Approved drugs | CLOSTRIDIUM-DIFFICILE INFECTION | PROTEIN-KINASE-C | CHEMISTRY, MEDICINAL | ADVANCED SOLID TUMORS | CELL-CYCLE ARREST | RESISTANT STAPHYLOCOCCUS-AUREUS | VESICULAR MONOAMINE TRANSPORTER-2 | VASCULAR-DISRUPTING AGENT | IMMUNODEFICIENCY-VIRUS TYPE-1 | METHYLATED NORDIHYDROGUAIARETIC ACIDS | IN-VITRO ACTIVITY | Plant Extracts - chemistry | Plant Extracts - pharmacology | Anti-Infective Agents - pharmacology | Cardiovascular Diseases - drug therapy | Humans | Drug Discovery - methods | Metabolic Diseases - drug therapy | Biological Products - pharmacology | Communicable Diseases - drug therapy | Inflammation - drug therapy | Anti-Infective Agents - chemistry | Anti-Inflammatory Agents - therapeutic use | Antineoplastic Agents, Phytogenic - pharmacokinetics | Biological Products - therapeutic use | Plants, Medicinal - chemistry | Anti-Inflammatory Agents - pharmacology | Nervous System Diseases - drug therapy | Anti-Infective Agents - therapeutic use | Antineoplastic Agents, Phytogenic - chemistry | Cardiovascular Agents - pharmacology | Neoplasms - drug therapy | Cardiovascular Agents - therapeutic use | Biological Products - chemistry | Animals | Anti-Inflammatory Agents - chemistry | Antineoplastic Agents, Phytogenic - pharmacology | Plant Extracts - therapeutic use | Cardiovascular Agents - chemistry | Drugs | Drug approval | Nurse practitioners
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15. Full Text Advanced therapy medicinal products for rare diseases: State of play of incentives supporting development in Europe
by Farkas, Andreas M and Mariz, Segundo and Stoyanova-Beninska, Violeta and Celis, Patrick and Vamvakas, Spiros and Larsson, Kristina and Sepodes, Bruno
Frontiers in Medicine, ISSN 2296-858X, 2017, Volume 4, Issue MAY, p. 53
In 2008, the European Union introduced the Advanced Medicines Regulation aiming to improve regulation of advanced therapy medicinal products (ATMPs). We... 
Advanced therapy medicinal products | European orphan medicines regulation | Orphan designation | Cell therapy | Gene therapy | Committee for Orphan Medicinal Products | MEDICINE, GENERAL & INTERNAL | cell therapy | gene therapy | advanced therapy medicinal products | orphan designation
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16. Herbs for Effective Treatment of Diabetes Mellitus Wounds: Medicinal Chemistry and Future Therapeutic Options
by Hussan, Farida and Hussan, Farida and Yahaya, Mohamad Fairuz and Yahaya, Mohamad Fairuz and Teoh, Seong Lin and Teoh, Seong Lin and Das, Srijit and Das, Srijit
Mini reviews in medicinal chemistry, ISSN 1389-5575, 2018, Volume 18, Issue 8, pp. 697 - 710
The incidence of diabetes mellitus (DM) has increased globally. Various complications such as blindness, nephropathy leading to renal failure, neuropathy, foot... 
Angiogenesis | healing | wound | insulin | macrophage | diabetes mellitus | herb | HEALING ACTIVITY | OXIDATIVE STRESS | CHEMISTRY, MEDICINAL | TOPICAL APPLICATION | PIPER-BETLE | ALOE-VERA | MATRIX-METALLOPROTEINASES | MOMORDICA-CHARANTIA L | BITTER GOURD | GROWTH-FACTOR EXPRESSION | GLYCATION END-PRODUCTS | Diabetes Mellitus - pathology | Plant Extracts - chemistry | Plant Extracts - pharmacology | Humans | Diabetes Mellitus - metabolism | MicroRNAs - metabolism | Biological Products - pharmacology | Chemistry, Pharmaceutical | Metalloproteases - metabolism | Intercellular Signaling Peptides and Proteins - metabolism | Plants - metabolism | Glycation End Products, Advanced - metabolism | Plants - chemistry | Wound Healing - drug effects
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17. Full Text Targeting the Receptor for Advanced Glycation Endproducts (RAGE): A Medicinal Chemistry Perspective
by Bongarzone, Salvatore and Savickas, Vilius and Luzi, Federico and Gee, Antony D
Journal of Medicinal Chemistry, ISSN 0022-2623, 09/2017, Volume 60, Issue 17, pp. 7213 - 7232
The receptor for advanced glycation endproducts (RAGE) is an ubiquitous, transmembrane, immunoglobulin-like receptor that exists in multiple isoforms and binds... 
CYTOPLASMIC DOMAIN | AMYLOID-BETA PEPTIDE | OXIDATIVE STRESS | CHEMISTRY, MEDICINAL | CELL-SURFACE RECEPTOR | NEURITE OUTGROWTH | SIGNALING PATHWAY | ALZHEIMERS-DISEASE | END-PRODUCTS RAGE | NF-KAPPA-B | SOLUBLE RECEPTOR | Neoplasms - metabolism | Small Molecule Libraries - pharmacology | Receptor for Advanced Glycation End Products - chemistry | Reactive Oxygen Species - metabolism | Cardiovascular Diseases - metabolism | Cardiovascular Diseases - drug therapy | Humans | Receptor for Advanced Glycation End Products - metabolism | Diabetes Mellitus - drug therapy | Small Molecule Libraries - therapeutic use | Diabetes Mellitus - metabolism | Drug Discovery - methods | Receptor for Advanced Glycation End Products - antagonists & inhibitors | Neurodegenerative Diseases - metabolism | Neurodegenerative Diseases - drug therapy | Neoplasms - drug therapy | Protein Domains - drug effects | Small Molecule Libraries - chemistry | Animals | Protein Isoforms - metabolism | Protein Isoforms - chemistry | Glycation End Products, Advanced - metabolism | Molecular Targeted Therapy - methods | Protein Isoforms - antagonists & inhibitors
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