Hello, diannasaurus-ga
What an interesting question! I have found some solid information
for you which I believe will prove useful.
There are as many as 50,000 serious burns per year world-wide,
making artificial skin a tremendous market. “Biomaterials: Your Life
May Depend on Them” at http://www.biomateria.com/media_briefing.htm
A 1996 article had these statistics:
“The clinical requirement for artificial graft materials to promote
effective wound repair is large. The cost of treating major dermal
lesions has been estimated at US$2000 each year. Examples of chronic
or seriously deficient wounds include pressure sores (decubitus
ulcers), diabetic skin ulcers, venous stasis ulcers, burn injury and
defects arising following tumour excision. In the US alone, there are
100,000 hospital treated burns per year and 600,000 cases of surgical
skin excision - burn wounds costing an estimated $70 million per
annum.” Read “Tissue Engineered Skin.” (8/20/1996) at
http://www.leahcim.demon.co.uk/temp/skinrev.htm
Though skin transplants from unnaffected parts of the body were
previously the norm in treating severe burns, undesireable side
effects, such as the creation of additional wound sites, has prompted
research into alternative methods of skin replacement. Read “Skin
Solution.” Audubon Update (1996) at
http://cpmcnet.columbia.edu/news/audubon/archives/audu_v2n1_0004.html
There is a “possible $130 million market for artificial skin in the
U.S and Europe” to help the millions of people severely burned each
year, according to an undated article about the use of Integra, a
collagen matrix developed by Johnson and Johnson and Integra Life
Sciences. Integra, which helps the body naturally regenerate it’s
cells, “allows immediate wound closure after a burn wound.” In
clinical trials of 228 burn patients, there was no incidence of
rejection. However, wound infection is possible. In such cases, the
Integra must be removed and the infection treated before Integra is
reapplied. According to the article, Integra “allows earlier chance
for rehabilitation. Under normal conditions when the dermis is
destroyed, it cannot regenerate. Usual methods of treating severe
burns are skin grafting and harvesting from cadavers (dead people).
Integra provides a base for cells to grow. The article, titled
“Artificial Skin, Cartiladge and Nerve Conduits,” can be found at
http://cape.uwaterloo.ca/che100projects/organs/Skin/skin.htm
Interestingly, skin replacement therapies proved valuable after the
September 11th terrorist attacks in New York City, according to Janice
Bourque, president of the Massachusetts Biotechnology Council in
Cambridge. Read “US Hoping New Companies Will Enter Contract Bidding,”
by Adria Cimino. Mass High Tech (12/3/2001) at
http://www.mtpc.org/fedfund/contract.htm
The United States is the clear leader in the biomaterials skin
replacement market, with Europe a close second. While Dr. Mark
Ferguson, a professor of Cell Biology at the University of Manchester,
UK, was studying methods to replace new tissue, “U.S. companies like
Organogenesis and Genzyme were barreling ahead with skin replacements
that are now on the market.” Some therapies currently being researched
in Europe, however, are very interesting. I have excerpted the
following information from the article, “Cell-Based Cures Could
Energize Biotech in Europe,” by Phillip Ross. Red Herring(12/11/2001):
“In what is known as autologous grafting, cells are taken from the
patient, manipulated in a lab, and reimplanted. The idea, pioneered 15
years ago in the United States, has become popular in Europe, where
many countries classify self-grafts as nondrugs, which exempts them
from regulatory approval requirements. Even so, Modex Therapeutics, in
Lausanne, Switzerland, has volunteered to stage human trials for its
autologous skin replacement, EpiDex, to win over doctors, insurers,
and regulators. Early results are promising; final data is due in
2002.”
“Modex takes hair from the head of a patient and uses it to grow new
skin (in 1-cm disks) for hard-to-heal leg ulcers, a market that could
easily total $1.5 billion in the United States and Europe, according
to estimates. "It's very thin, very proliferative, with 25 percent of
the cells dividing; in normal skin, it's just 5 percent," says Edward
Baetge, Modex's chief scientific officer.”
“Modex is working on a more easily administered version that uses
off-the-shelf (i.e., nonautologous) skin replacements, which should
therefore be simpler and cheaper to administer. Scientific hurdles
aside, the company also faces competition from--no surprise--a U.S.
biotech company. Organogenesis, in Canton, Massachusetts, won U.S.
Food and Drug Administration approval for its autologous
skin-replacement productin 1998." Read the entire article at
http://www.redherring.com/mag/issue108/957.html
Genzyme is a US company well-know for it’s artificial skin
replacement products. EpicelŪ (cultured epidermal autografts), an
autologous cell therapy, is the only permanent skin replacement for
some 100 severe burn victims each year. Read “Technology Platforms.”
Genzyme (2002) at http://www.genzyme.com/research/technology/tech_home.asp
Intercytex, with branches in the US and the UK, “is working in the
field of dermal repair to produce a second-generation tissue
engineered skin, suitable for use in both acute and chronic dermal
lesions. Tissue engineered skin is a much needed product as there are
over 600 patients with treatable burns, 4 million trauma cases and 2.6
million chronic dermal wounds each year in the US alone. This will be
one of the company’s first products to enter the clinic.” Read
“Intercytex.” (6/1/2001) at
http://212.67.202.140/~biotech/News/Unlisted/intercytex_limited.htm
A partial description of Advanced Tissue Science Company’s
techniques for skin replacement follows:
“The production of human tissues outside the body “utilizes stromal
cells, which are the cells that form the surrounding matrix of a
tissue. These cells are seeded onto three-dimensional scaffolding and
placed into specially designed bioreactors to simulate the body.
There, the cells multiply in layers, secreting proteins and numerous
cellular factors, ultimately forming a tissue matrix. Tissue-specific
cells are then seeded onto the matrix to form a living tissue
equivalent that can be used to repair or replace a patient's own
damaged tissue.”
“The company’s original focus was on structural tissues. We started
with skin, and the first product being TransCyte™, a temporary skin
replacement that addresses severe and partial thickness burns. The FDA
(U.S. Food and Drug Administration) approved this product, and we are
now heading forward with Dermagraft™ permanent dermal replacement skin
product. This product treats severe wounds such as diabetic skin
ulcers, which affects the many, many patients with diabetes and can
often lead to surgical revisions and amputations.”
“What this means for a burn victim today is that instead of having
to go through painful, painful dressing changes three times a day—that
require morphine and a hospital stay of a couple of weeks—they can get
a tissue engineered product. In our case, it is called Trancytes. It
not only helps reduce the pain immediately, but it also allows
hospital discharge in a day or two, and much more rapid healing. It is
affecting many, many patients today with burns, particularly children.
There is long-term trauma involved with the tremendous pain that burn
patients have to endure while in the hospital.
Read “Dr. Gail K. Naughton: Advances in Tissue Engineering,” by Lilly
Manske. MedTech Hero (10/20/2000) at
http://www.medtech1.com/hero/medtech_hero.cfm/3/1
An interesting chart of US companies which produce "therapies for
burns, skin
wounds, ulcerations and chemotherapy effects,” with descriptions of
the skin replacement techniques and some statistics on the number of
patients currently using particular therapies, can be found at
http://www.bitsplace.com/bitsplace/Skintherapycomp.html
To read about Shriner’s Hospital’s use of Integra for young burn
patients, refer to “Medical Advancements. Kids Making Great Strides
With Latest Treatments.” (7/22/2001) at
http://www.shrinershq.org/WhatsNewArch/Archives97/latest4-97.html
Please let me know if I can be of further help.
umiat-ga
Google Search strategy
+"skin replacement" +US Market |
