Regenerative medicine

Regenerative medicine is generally
defined as therapy that uses living
cells to repair the body.

Regenerative medicine  empowers
scientists to grow tissues and organs
in the laboratory and safely implant
them when the body cannot heal itself.
Importantly, regenerative medicine has
the potential to solve the problem of
the shortage of organs available for
donation compared to the number of
patients that require life-saving organ
transplantation, as well as solve the
problem of organ transplant rejection,
since the organ's cells will match that
of the patient.

Regenerative medicine is more than
just promising science, it is fast
becoming  profitable.

Doctors have replaced the cancer-
stricken windpipe of a patient with an
organ made in a lab, a landmark
achievement for regenerative
medicine. The patient no longer has
cancer and is expected to have a
normal life expectancy, doctors said.

"He was condemned to die," said Paolo
Macchiarini, a professor of
regenerative surgery who carried out
the procedure at Sweden's Karolinska
University Hospital.

The patient's speedy recovery marks
another milestone in the quest to make
fresh body parts for transplantation or
to treat disease. More immediately, it
offers a possible treatment option for
thousands of patients who suffer from
tracheal cancer or other dangerous
conditions affecting the windpipe.

In March last year a 10-year-old British
boy received a windpipe that had been
impregnated with his own stem cells,
which meant he did not have to take
powerful immuno-suppressant drugs.
However, it used a trachea, or
windpipe, originally taken from a 30-
year-old woman.

This new technique does not need a
donor: it was created from scratch with
the help of technology from University
College London.

Scientists there were given three-
dimensional CT scans of the windpipe
of the patient Andemariam
Teklesenbet Beyene, a geology
student from Eritrea.

From the scans, Prof Alex Seifalian
and colleagues created a glass mould
of Mr Beyene's windpipe and his two
main bronchial tubes.

The Y-shaped structure was then
coated in a special polymer containing
millions of tiny holes.

This was placed in a bioreactor for two
days to allow the stem cells to take
root. Cells to line the replacement
windpipe were also used, taken from
the patient's nose.
The bioreactor was made by
researchers at Harvard Bioscience Inc.
of Holliston, Mass., a shoe-box-size
device similar to a spinning rotisserie
machine. The artificial scaffold was
placed on the bioreactor; then, stem
cells extracted from the patient's bone
marrow were dripped onto the
revolving scaffold for two days.

It took Prof Macchiarini 12 hours to
perform the operation, first removing
the tumour and the diseased windpipe
and then installing the replacement.

He has previously undertaken 10
windpipe operations, including the first
of a tissue-engineered trachea, on a
30-year-old Spanish woman called
Claudia Costillo in 2008.

However, this is the first not to require
a donor organ.

To date, 250,000 patients have been
treated with Apligraf, and the company
is now in the middle of a $60 million
expansion of its manufacturing facilities
in Canton, USA. The new facilities are
expected to open in late 2013.

When a foot or leg ulcer lingers for
weeks months or even years without
healing, it can seem hopeless. It’s
frustrating when your body just does
not heal, no matter what treatments
you try. But there is real hope for
healing your ulcers with Apligraf,
utilizing the latest in biotechnology for
wound care.

Apligraf consists of living cells, proteins
produced by the cells and collagen.
Apligraf is not another ointment or
dressing. It is a living, cell based
product that helps promote healing of
venous leg ulcers and diabetic foot
It is created from cells found in healthy
human skin. Which explains why it
looks like a thin piece of real skin.

It is used to heal ulcers such as
diabetic foot and venous leg ulcers
that are not healing after 3-4 weeks,
despite treatment with conventional

When healthy skin gets wounded, the
proteins and growth factors in the skin
stimulate the body to regenerate new
skin. This is the normal wound healing

However with certain diseases (like
diabetes and circulatory problems), the
skin is missing these biological
substances, and the healing cycle is
broken. This leads to the development
of non-healing ulcers and wounds.

Apligraf contains two types of cells –
an outer layer of protective skin cells,
and an inner layer of cells contained
within collagen. Both types of cells
contain substances similiar to those
found in human skin. Apligraf does not
contain certain things in skin such as
hair follicles, sweat glands or blood

Apligraf plays an active role in healing
by providing to the wound living cells,
proteins produced by the cells, and
collagen, which are important for

Apligraf is different because it is NOT a
cream, ointment, or traditional wound
dressing. It is a living treatment made
to treat non-healing ulcers.

Apligraf is placed directly on the wound.

The wound is then covered with a non-
adhesive dressing to keep Apligraf in
place. The area is then wrapped with
other dressings that are changed
weekly by the doctor or nurse. The
healing process now begins, and
improvement of the wound can usually
be seen within weeks.

Many wound therapies, like dressings
and antibacterial treatments, are
designed to manage a wound until the
body heals itself. Apligraf plays a more
active role in the wound healing
process. Apligraf delivers to the wound
living cells, proteins produced by the
cells, and collagen which are important
for healing.

Apligraf is a prescription product that
must be applied by a medical
professional. It is not available in
pharmacies nor can it be purchased

At Organogenesis, the next product in
the pipeline is a therapy for the
regeneration of oral soft tissue. The
product, known as CelTx, finished
Phase 3 testing last year and is
awaiting FDA approval. The company
hopes to get the top 40 or 50 leading
clinicians in the U.S. to adopt the
product first, before seeking broader


Westport, Conn.-based Advanced
BioHealing Inc. has commercialized a
bio-engineered skin substitute,
Dermagraft, used to treat diabetic foot

Cambridge-based Pervasis
Therapeutics Inc. is on track to have
its first product on the market by 2014,
said CEO Fred Chereau. The product,
Vascugel, is a cell-based therapy that
aims to enhance blood vessel repair.
The product recently won the go-
ahead from the FDA to begin Phase 3
clinical trials, which Chereau said
should start by the end of the year.

Other therapies that fall within the
category of regenerative medicine are
not as close to commercialization.
Therapies using stem cells to repair
nerve or cardiac damage are heavily
researched and in high demand, but
they’re also far from ready.