Allogeneic
cells sourced from an unrelated donor, someone other than the
recipient.
Autologous
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.
Chronic wounds
wounds that will not heal following a course of standard therapy.
Collagen
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.
Cell biology
(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.
Compression bandaging
the use of elasticated bandages to create graduated compression of
the tissues and blood vessels within the leg in an attempt to
counteract venous stasis or stagnation of the blood flow. As
stasis is usually most pronounced in the extremities, the
compression is greatest at the ankle and reduced in a graduated
manner as the bandaging moves up the leg.
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.
Dermal fibroblasts
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.
Dermal papilla cells
cells which are responsible for the formation of new hair and which
are found at the basal region of the hair follicle. In the adult
hair follicle, these cells play a crucial role in dermal-epidermal
interactions that control hair production and hair cycling.
Dermal rhytids
commonly known as wrinkles; creases, often deep, form in the skin
due to age, stress, sun damage and other sources.
Dermatitis
a general term meaning inflammation of the skin.
Dermis
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.
Diabetes mellitus
a chronic condition in which the body produces insufficient insulin
or ineffectively responds to it.
Diabetic foot ulcer (DFU)
ulceration of the lower limb usually caused by nerve damage and
poor peripheral circulation in diabetics, which means damage may go
unnoticed and pressure sores develop, both of which can become
chronic ulcers.
Female diffuse alopecia
gradual thinning of hair, especially on the top of the head
although the hairline generally remains intact. Female diffuse
alopecia progresses more slowly than male pattern baldness because
of the small amount of male hormones in a woman's body. A hormone
imbalance may make the problem worse. Temporary hair loss may
result from any shock to the body's systems, including starvation,
systemic infection, childbirth, thyroid or immunologic disorders,
drugs (especially chemotherapy for cancer), or stress. Hair
follicles can be destroyed permanently by scarring from burns,
severe scalp infections, X-ray therapy, or skin disorders. Damage
may also result from tight hairstyles over a long period of time,
chemical treatments such as hair colouring or permanents, or the
habitual pulling out of the hair.
Fibrin
an insoluble protein formed during haemostasis or blood clotting,
comprising the essential part of a blood clot. In ICX-PRO,
the fibrin-based gel matrix maintains the HDFs’ functions and
it gradually degrades after it has been applied to the wound -
allowing the HDFs to initiate healing.
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.
GMP
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.
Histological
the anatomical study of the microscopic structure of animal and
plant tissues. SKN
Intradermally
into the skin.
Keratinocytes
the primary cell types found in the epidermis or the outer layer of
skin.
Male pattern baldness
also known as MPB or Androgenetic Alopecia. This is the most common
type of hair loss that is caused by hormones, and affects the
central and frontal area of the scalp and often results in a
pronounced horseshoe pattern.
MHRA
the Medicines and Healthcare products Regulatory Agency. The
UK government agency responsible for ensuring the medicines and
medical devices work and are acceptably safe.
Microinjection
the delivery of small quantities of fluid and cells using fine
gauge needles.
Molecular biology
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.
Nasolabial folds
lines which run from the sides of the nose to the corners of the
mouth.
Open-label
a clinical trial in which both participants and investigators know
what drug is being tested and what dosages are being used.
Phase I
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.
Phase II
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.
Phase III
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.
Placebo
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.
Reperfusion
the physiological process in which new blood vessels and blood
supply develop.
Stasis
stagnation or inactivity; statis dermatitis is caused by poor
circulation in the legs.
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.
Tissue engineering
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.
Venous leg ulcer (VLU)
ulceration of the lower limb, usually caused by the accumulation of
toxins due to venous stasis, the pooling of blood in the legs due
to the poor return of blood to the heart. Venous stasis can
be caused by long term immobility or vascular disease.
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