Perinatal derivatives are drawing growing interest among the scientific community as an unrestricted source of multipotent stromal cells, stem cells, cellular soluble mediators, and biological matrices. They are useful for the treatment of diseases that currently have limited or no effective therapeutic options by means of developing regenerative approaches. In this paper, to generate a complete view of the state of the art, a comprehensive 10-years compilation of clinical-trial data with the common denominator of PnD usage has been discussed, including commercialized products. A set of criteria was delineated to challenge the 10-years compilation of clinical trials data. We focused our attention on several aspects including, but not limited to, treated disorders, minimal or substantial manipulation, route of administration, dosage, and frequency of application. Interestingly, a clear correlation of PnD products was observed within conditions, way of administration or dosage, suggesting there is a consolidated clinical practice approach for the use of PnD in medicine. No regulatory aspects could be read from the database since this information is not mandatory for registration. The database will be publicly available for consultation. In summary, the main aims of this position paper are to show possibilities for clinical application of PnD and propose an approach for clinical trial preparation and registration in a uniform and standardized way. For this purpose, a questionnaire was created compiling different sections that are relevant when starting a new clinical trial using PnD. More importantly, we want to bring the attention of the medical community to the perinatal products as a consolidated and efficient alternative for their use as a new standard of care in the clinical practice.

Biomatériaux et Inflammation en Site Osseux EA 4691 Université de Reims Champagne Ardenne Reims France

Department of Biochemical Engineering Advanced Centre for Biochemical Engineering University College London London United Kingdom

Department of Burns and Plastic Surgery Faculty of Medicine Institution Shared With University Hospital Brno Masaryk University Brno Czechia

Department of Laboratory Medicine Division of Pathology Karolinska Institutet Stockholm Sweden

Department of Molecular Cell Biology Institute of Biochemistry Life Sciences Center Vilnius University Vilnius Lithuania

Division of Molecular Biology Rudjer Boskovic Institute Zagreb Croatia

Educell ltd Trzin Slovenia

Établissement Français du Sang Nouvelle Aquitaine France INSERM U1035 Université de Bordeaux Biothérapie des Maladies Génétiques Inflammatoires et Cancers Bordeaux France

EXO Biologics Liege Belgium

Experimental Ophthalmology Group University of Murcia and Instituto Murciano de Investigación Biosanitaria Campus Ciencias de la Salud Murcia Spain

German Society for Tissue Transplantation gGmbH Hannover Germany

Laboratoire de Nanomédecine Imagerie Thérapeutique Université Bourgogne Franche Comté Besançon France

Laboratory of Biosynthesis of Nucleic Acids Institute of Molecular Biology and Genetics Department of Functional Genomics National Academy of Science Kyiv Ukraine

Placenta Stem Cell Laboratory Cryobank Institute of Cell Therapy Kyiv Ukraine

PrimeCell Bioscience Ostrava Czech Republic

Regeneration Molecular Oncology and TGFβ IMIB Arrixaca Murcia Spain

Service de Chirurgie Orthopédique Traumatologique et Plastique CHU Besançon France

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