somatic cell gene therapy | somatic gene therapy | somatic cell therapy | somatic therapy

somatic gene therapy

somatic cell therapy

somatic gene therapy

Definition: Symptoms are presented by the patient as if they were due to a physical disorder of a system or organ that is largely or completely under autonomic innervation and control, i.e. the cardiovascular, gastrointestinal, respiratory and urogenital systems. The symptoms are usually of two types, neither of which indicates a physical disorder of the organ or system concerned. First, there are complaints based upon objective signs of autonomic arousal, such as palpitations, sweating, flushing, tremor, and expression of fear and distress about the possibility of a physical disorder. Second, there are subjective complaints of a nonspec ...[+++]ific or changing nature such as fleeting aches and pains, sensations of burning, heaviness, tightness, and feelings of being bloated or distended, which are referred by the patient to a specific organ or system. | Cardiac neurosis Da Costa's syndrome Gastric neurosis Neurocirculatory asthenia Psychogenic forms of:aerophagy | cough | diarrhoea | dyspepsia | dysuria | flatulence | hiccough | hyperventilation | increased frequency of micturition | irritable bowel syndrome | pylorospasm

Guidelines for Research on Somatic Cell Gene Therapy in Humans

Definition: Includes miscellaneous conditions causally related to brain disorder due to primary cerebral disease, to systemic disease affecting the brain secondarily, to exogenous toxic substances or hormones, to endocrine disorders, or to other somatic illnesses.

Definition: The essential feature is a persistent preoccupation with the possibility of having one or more serious and progressive physical disorders. Patients manifest persistent somatic complaints or a persistent preoccupation with their physical appearance. Normal or commonplace sensations and appearances are often interpreted by patients as abnormal and distressing, and attention is usually focused upon only one or two organs or systems of the body. Marked depression and anxiety are often present, and may justify additional diagnoses. | Body dysmorphic disorder Dysmorphophobia (nondelusional) Hypochondriacal neurosis Hypochondriasis ...[+++]Nosophobia

behavior therapy | behaviour therapy | behavioral therapy | behavioural therapy

New scientific progress in cellular and molecular biotechnology has led to the development of advanced therapies, such as gene therapy, somatic cell therapy, and tissue engineering.

Additionally, advanced therapies being a field subject to rapid scientific progress, it is necessary to keep the definitions of gene therapies, somatic cell therapies, and tissue engineered products under continuous review. New innovative products, which are not clearly captured by existing provisions, are emerging.

Scientific progress has brought about a new type of medicinal products based on gene therapy, somatic-cell therapy or tissue engineering.

Due to scientific and technical progress in the field of advanced therapies, as reflected in Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 , it is appropriate to adapt Annex I. The definitions and detailed scientific and technical requirements for gene therapy medicinal products and somatic cell therapy medicinal products should be updated.