About this Research Topic

Background

This Research Topic is part of a series with:
Perinatal Derivatives and the Road to Clinical Translation, Volume II

In the past 15 years there has been significant advances in the research and understanding of the biology of perinatal derivatives. Perinatal derivatives (PnD) refers to birth-associated tissues that are obtained from term placentas and fetal annexes, and more specifically refers to the amnionic membrane, chorionic membrane, chorionic villi, umbilical cord (including Wharton’s jelly), the placenta basal plate (including maternal and fetal cells), and the amniotic fluid. The term “derivatives” is used to refer to the cells isolated from placental tissues, and the factors that these cells release, referred to as their secretome or conditioned medium [including free nucleic acids, soluble proteins, lipids, and extracellular vesicles (apoptotic bodies, microvesicles, exosomes)].

PnD are promising for a wide range of applications in regenerative medicine; as a matter of fact, many studies that have investigated the properties of perinatal derivatives have demonstrated that they may represent important tools for restoring tissue damage or promoting regeneration and repair of the tissue microenvironment. A variety of PnD have been investigated in regenerative medicine, but their translation into clinical practice has been, to date, haphazard, incomplete and slow, ultimately limiting their therapeutic potential.
In order to fully exploit the successful and efficient clinical applications of PnD, and to determine which PnD is optimal for defined diseases, there are several issues that must be addressed.

Firstly, reference nomenclature for PnD must be established and consensus and guidelines for the donor eligibility, collection, culture, and cryopreservation should be defined. Criteria for PnD in vitro characterization will allow for the comparison of results in order to determine PnD efficacy in preclinical studies. Secondle, studies in animal models must be reviewed in order to grade efficacy of therapeutic interventions and identify research gaps for the disease of interest. In addition, new treatment modalities for pre-clinical studies relative to the identified research gaps must be defined in order to propose disease-specific therapeutic approaches using PnD, based on their potential to differentiate into tissue-specific cells or to induce bystander effects through their secretome. A clear understanding of the therapeutic potential and underlying mechanisms will allow for the identification of which PnD could potentially provide the optimal results in specific diseases. Thirdly, approaches exploiting PnD differentiation capabilities and exploiting paracrine actions of PnD cells must be further investigated. This will allow for the understanding of the potential clinical applications of PnD and identify diseases to consider PnD as potential clinical treatment. Lastly, general regulatory issues for PnD must be discussed in order to set commonly accepted good manufacturing practice (GMP) and regulatory standards, and ultimately guide clinicians for optimal clinical trial design and the successful implementation of efficient and safe clinical trials.

This Research Topic will showcase a joint effort from the COST SPRINT Action which deals with different issues that need to be faced in order to ensure optimal research results and interpretation of clinical trial data.

The Research Topic is divided into 2 parts (Volumes I and II), to be open consecutively, with a focus on:

• Obtaining consensus for the nomenclature and for the optimal techniques for the isolation characterization, cryopreservation, and culture of perinatal derivatives
• Understanding of mechanisms and therapeutic actions of perinatal derivatives
• The collection of basic research data useful for designing clinical trials
• Identifying research gaps so as to guide future research on perinatal derivatives and streamline translation to the clinic

Keywords: Regenerative Medicine, Perinatal, Secretome, In Vitro Characterization, Consensus

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