Glossary of terms

Regenerative medicine is a field of healthcare focused on harnessing the body's natural ability to heal and regenerate damaged tissues or organs. It involves techniques such as stem cell therapy, tissue engineering, and gene therapy. The goal is to restore normal function to diseased or injured tissues. Regenerative medicine could offer new treatments for a wide range of medical conditions, from heart disease to spinal cord injuries.

Entities designated by law for authorisation, approval, evaluation, oversight, surveillance, and/or adoption of guidance in a specific field. In the context of gene and cell therapies, multiple regulators are involved throughout the development cycle: medicines agencies (European or National), Health Technology Assessment bodies, research funding and authorisation authorities, patent offices, ethics bodies/committees, notified bodies (in the context of combination with medical devices), data authorities, etc.

A research protocol is a reference document on the methodology and organisation of clinical trials.

A retrovirus is a type of virus that uses RNA as its genetic material. Unlike most viruses, which use DNA as their genetic material, retroviruses have a unique replication process. When a retrovirus infects a cell, it uses an enzyme called reverse transcriptase to convert its RNA genetic material into DNA. This newly-made DNA is then integrated into the host cell's genome. Once integrated, the cell's own machinery is tricked into using the retroviral DNA as if it were its own genetic material. This allows the retrovirus to replicate and spread to other cells. This process is what distinguishes retroviruses from other types of viruses. Many retroviruses are associated with diseases in humans, including HIV, which causes AIDS, and HTLV-1, which can lead to adult T-cell leukemia. Retroviruses have also been used in gene therapy due to their ability to integrate into the host genome, offering a potential method for delivering therapeutic genes into cells.

The ratio between the advantages (benefits) and disadvantages (risks) of a medicine or a medical device.

RNA, or ribonucleic acid, is a crucial molecule for all living cells, serving as a messenger in cellular functions and protein production. Similarly to its sister molecule DNA, RNA consists of a chain of nucleotides including adenine (A), cytosine (C), and guanine (G), but whereas DNA contains thymine (T) nucleotides, in RNA thymine is replaced with uracil (U). Additionally, in cells, DNA typically exists in a double-stranded form, while RNA is a single-stranded molecule. During protein production, RNA serves as a messenger that copies genetic information from the DNA and functions as a template for protein synthesis.