A Glossary of terms used at Intercytex.
Acne is a common condition that affects most people at some point in their lives. For reasons that are not understood some people develop severe acne that leads to permanent and sometimes disfiguring scarring. The term "scarring" refers to a process where collagen within the skin is damaged from inflammation, leading to permanent texture changes in the skin. There are different kinds of acne scarring: ice pick scarring, atrophic scarring, and hypertrophic scarring. Ice pick scars are deep pitted scars with steep edges. Atrophic scars are pitted but have smooth borders and are not as deep. Hypertrophic scar, more common on the back and chest, are thick lumpy scars that sit above the surface of the skin.
cells sourced from an unrelated donor, someone other than the recipient.
cells sourced from an individual and returned to that same individual.
Basal cell carcinoma
the most common form of skin cancer. Treatment is with surgery, topical chemotherapy, x-ray, cryosurgery or photodynamic therapy. It is rarely life-threatening but, if left untreated, can be disfiguring, cause bleeding and produce local destruction (eg, eye, ear, nose, lip). Basal cell skin cancer almost never spreads; but, if untreated, it may grow into surrounding areas and nearby tissues and bone.
Biologics licence application (BLA)
The drug regulatory process in which companies apply to the US FDA for permission to market biological products in the US. The US Food and Drug Administration (FDA) is the US Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices.
wounds that will not heal following a course of standard therapy.
a tough, insoluble protein found throughout the body in the connective tissues that holds muscles and organs in place. In the skin, collagen supports the epidermis, making it durable and elastic. Forming a meshwork of fibres, collagen is key to the structure and texture of skin. As collagen in the meshwork breaks down, it is replaced and repaired by collagen secreted from fibroblasts. With age, the skin's ability to repair collagen diminishes, and the collagen meshwork begins irretrievably to break down. This manifests itself in the form of wrinkles.
(cellular biology) the study of the physiological (functions) properties of cells, as well as their behaviours, interactions, and environment; this is done both on a microscopic and molecular level. Cell biology researches both single-celled organisms like bacteria and specialised cells in multi-cellular organisms like humans.
Data Safety Monitoring Board (DSMB)
An independent panel of clinical research experts and statisticians that review the results of key clinical trials while they are underway, a process required by all regulatory bodies.
human dermal fibroblasts or HDFs are the cells which are responsible for and orchestrate the wound healing process and which may be absent or dysfunctional in chronic wounds.
Allogeneic HDFs are derived from the dermis of normal human skin.
HDFs are the principal cell type found in the dermal layer of human skin where they secrete collagen, the main component of the dermis.
commonly known as wrinkles; creases, often deep, form in the skin due to age, stress, sun damage and other sources.
a general term meaning inflammation of the skin.
the layer of skin just underneath the epidermis that contains sensitive nerve endings, blood vessels and hair follicles. During manufacture of ICX-SKN, HDFs gradually build a dense collagenous meshwork which is largely responsible for the product's tensile properties and high durability.
Epidermolysis Bullosa (EB) refers to a clinically heterogeneous group of rare blistering skin disorders. One of the most clinically severe subtypes of EB is Recessive Dystrophic EB (RDEB) and it is the first clinical target for ICX-RHY-013.
RDEB is an autosomal recessive condition is caused by loss-of-function mutations in the COL7A1 gene, which encodes the skin protein type VII collagen (C7) (Dang and Murrell Exp Dermatol 2008; 17: 553-68). Loss of C7, which is expressed in the basement membrane at the junction between the epidermis and the dermis, leads to structural defects in adhesion structures known as anchoring fibrils. These changes make the skin fragile and susceptible to blistering following trauma. Blistering often leads to chronic erosions and there is poor wound healing of traumatised skin. In addition, the impaired healing can be followed by scarring and contractures, as well as several major cutaneous and systemic complications (Fine and Mellerio J Am Acad Dermatol 2009; 61: 367-84 and 387-402). These complications include an increased risk of skin malignancy, anaemia, oesophageal stricture, nutritional deficiencies, constipation, ocular scarring, dental decay, endocrine abnormalities, and osteoporosis. RDEB also has a major impact on quality of life, social and family interactions (Frew et al. Br J Dermatol 2009; 161: 1323-30) At present, there is no effective treatment for RDEB; current best practice involves application of protective dressings (which can take several hours each day and which is often painful) and monitoring/attempting to treat disease complications.
a complex network of fibrous and non-fibrous materials that contribute to the structure and appearance of the skin. The extracellular matrix produces a structure that withstands the mechanical and physical forces imposed on the skin.
Food and drug administration (FDA)
The US Food and Drug Administration (FDA) is the US Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices.
Good Manufacturing Practice; formal standards for a facility's cleanliness, quality controls and documentation, set out and regularly monitored by the regulators. cGMP is current Good Manufacturing Practice.
the anatomical study of the microscopic structure of animal and plant tissues. SKN
into the skin.
the Medicines and Healthcare products Regulatory Agency. The UK government agency responsible for ensuring the medicines and medical devices work and are acceptably safe.
the delivery of small quantities of fluid and cells using fine gauge needles.
the study of biology at a molecular level. The field overlaps with other areas of biology, particularly genetics and biochemistry. Molecular biology chiefly concerns itself with understanding the interactions between the various systems of a cell, including the interrelationship of DNA, RNA and protein synthesis and learning how these interactions are regulated.
lines which run from the sides of the nose to the corners of the mouth.
a clinical trial in which both participants and investigators know what drug is being tested and what dosages are being used.
clinical testing of the safety of a treatment in healthy individuals. This is normally the first time a treatment is given to humans. In one or more clinical trials, safety, tolerability, dose range pharmacodynamic (action of a treatment on the body) and pharmacokinetic (the process by which a treatment is absorbed, distributed, metabolized, and eliminated by the body) profiles are investigated.
the first trial in which the treatment is given to patients with the condition for which it is believed it will have some beneficial effect. Positive efficacy is often referred to as "clinical proof of concept". This phase should conclude with evidence of whether the treatment works, which patient population to target and what is the optimal dose to strike a balance between beneficial effect and side effects.
a "dry run" of the final use of a treatment in the market. The trials in this phase need to provide a strong degree of statistical significance that the treatment presented at a particular dose, to a particular population, and in a particular formulation has sufficient efficacy along with appropriately low side effects. It is based on the evidence from Phase III trials that the regulatory authorities decide whether to approve a treatment.
an inactive version of the treatment that has no treatment value. In clinical trials, treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of the active treatment.
the physiological process in which new blood vessels and blood supply develop.
Injuries such as burns that involve damage to the dermis rarely heal without formation of a scar. Scar tissue is not identical to the tissue that it replaces and is usually more fibrous and of inferior functional quality. The scar shows an increase in the thickness of the new epithelial layer but the attachment of epidermis is poor making the surface vulnerable to further injury. Sometimes the scarred skin extends beyond the three-dimensional boundary of the original tissue resulting in a raised or hypertrophic scar. Hypertrophic scarring is seen in up to 50% of healed deep burns and this can lead to wound contracture if the scar affects a joint as the skin over the joint is firmer and less extensible and this in turn then limits movement of the joint. Both the contracture and hypertrophic scarring process peak between 3 and 6 months after injury and partially resolve at 12 to 18 months, frequently long after the patient has been discharged.
Restrictive contractures due to serious burn injuries can result in long term aesthetic and physical consequences. Skin contractures bridging or located proximal to a joint lead to joint deformities that severely restrict range of motion (ROM) of the effected joint. Skin contractures are also often accompanied by debilitating levels of chronic pain requiring a high dependency on pain medication. This pain medication can also lead to other undesirable side-effects and unwanted dependency on the drugs administered to control the pain. These factors in isolation or combined can lead to significant disruption in both social and professional life.
Squamous cell carcinomas
a form of cancer of that may occur in many different organs, including the skin, mouth, esophagus, prostate, lungs, and . It is a malignant tumor of the epithelium that shows squamous cell differentiation. This type of cancer can be seen on the skin, lips, inside the mouth, throat or esophagus and is characterised by red, scaly skin that becomes an open sore.
uses a combination of cells, engineering materials and suitable biochemical factors to improve or replace biological functions to effect the advancement of medicine. It may be defined as understanding the principles of tissue growth and applying this to produce functional replacement tissue for clinical use.