Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access
Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc
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Volume 12, Number 12, December 2020, pages 780-786

Advanced Therapy Medicinal Products Challenges and Perspectives in Regenerative Medicine


Figure 1.
Figure 1. Schematic representation of advanced medicinal therapeutic products. CAR: chimeric antigen receptor.


Table 1. Classification, Definition and Applications of ATMPs
ATMPs: advanced therapy medicinal products; ALS: amyotrophic lateral sclerosis.
Gene-based therapeutic medicinal productsGene transfer-based approaches which are leading to therapeutic, prophylactic or diagnostic effect.Inherited disease
Cancer therapy
Tissue regeneration (e.g., lost of sight)
Somatic cell therapeutic medicinal productsCell-based approaches which are including in vitro manipulating cells or tissues with therapeutic, prophylactic or diagnostic effect.Products against immune disease
Parkinson’s disease, ALS, Alzheimer’s disease
Cartilage defect
Product for cardiac repair
Skin replacement
Cancer immunotherapy
Tissue-engineered medicinal productsTissue engineered-based approaches that can be applied to repair, regenerate or replace human tissues or organs.Small diameter vascular grafts
Trachea replacement
Tissue-engineered esophagus
Liver and kidney implantation
Nerve conduits


Table 2. ATMPs Borderline Source: Alliance for Regenerative Medicine 2019
Advance therapy medicinal products borderlines
ATMPs: advanced therapy medicinal products.
Highly personalized therapyComplex manufacturing
Direct application through infusionHigh up-front cost
Longer lasting effectOne-time treatment
Address complex diseasesSpecific regulatory and pharmacovigilance demands
Improving health-related quality of lifeHighly specific storage requirements: short shelf life
Fewer hospitalizations, comorbidities and associate treatment