The adult stem cell marketplace is one of the most dynamic areas in life
science today. There are an incredible number of scientific advancements,
especially since 2008 as a heated pace of research discoveries and collaborations are underway among commercial companies, institutions and even a multi-institutional, interdisciplinary network initiative led by an executive department of the U.S. federal government.

Also, big pharma are beginning to invest heavily into regenerative medicine, and at least one state in the U.S. is proposing a bill that would create a special research consortium to maximize the benefits of adult stem cell research for its citizens.

Non-controversial adult stem cells hold great hope for successful treatments
and potential cures. In recent years these cells have provided therapeutic
benefits to human patients for 70+ diseases and conditions. Adult stem
cells exist within the body and have untapped potential to rescue and heal
tissue and organs that have been injured or diseased. They can be extracted from many types of tissues such as umbilical cord at birth, peripheral, bone marrow, adipose (fat) tissue, menstrual-derived blood, dental pulp, liver, skeletal muscle, placentas, and more.

A service of the National Institutes of Health called ClinicalTrials.gov
(http://www.clinicaltrials.gov), a registry of federally and privately
supported clinical trials conducted in the U.S. and around the world, showed
at the end of March 2009 there were more than 2,300 adult stem cell clinical
trials in various stages (completed, active, recruiting volunteers, and not
yet recruiting) investigating these cells use as potential breakthrough
therapies for a myriad of diseases.

“We estimate there are up to 300 firms worldwide engaged in some aspect of stem cell research and commercialization and the vast majority of stem cell companies are focused on adult stem cells: allogenic (taken from a different individual); autulogous (taken from an individual and transferred back to original donor); or cultured. And it is becoming increasingly clear that these stem cells can address up to 70 different clinical indications. Much of what is motivating these early pioneer patients is an existing
deep-seated demand for these therapies,” according to Robin Young, CFA, CEO of RRY Publications LLC, a market analysis firm in Wayne, Pa. His analysis and market forecasts (2009 - 2019) were presented at the 4th Annual Stem Cell Summit on February 17, 2009 in New York. (“Stem Cell Summit Executive Summary”; http://www.ryortho.com; click-on Bookstore)

“All three types of stem cells are now firmly in the marketplace. Over the
course of the last four years, approximately 30,000 patients have been
treated with allogenic stem cell products in the U.S.; 2,000 – 3,000 with
autologous stem cell products; and more than 1,000 with cultured stem cell
products,” stated the market report.

Stem cells as commercial products have demonstrable therapeutic value in 15 medical markets, according to Young’s analysis, such as heart muscle repair, nerve regeneration and diabetes treatment. “In 2008 in the U.S., there were 35 million patients available for eventual stem cell therapeutic treatment in the 15 markets analyzed. By 2018, we forecast stem cells will be used therapeutically in as many as 2 million annual procedures for an aggregate market penetration of approximately 6%. These products will be generating, we estimate, well over $8 billion in revenue.”

Cord Blood Fastest Growing Therapy Group

Dallas Hextell is living proof of the healing power of adult stem cells
there. He was diagnosed at eight months with cerebral palsy, which has no
known cure. Fortunately, Dallas’ parents had his umbilical cord blood stored
when he was born. He was accepted in a clinical trial at Duke University in
July 2007 and was among the first in the country to be intravenously infused
with his own cord blood stem cells to induce healing in his brain. Soon
after his procedure Dallas’ parents began noticing improvements. Today, with the help of therapists, Dallas is doing things no one thought possible. He runs, he laughs, and he’s beginning to talk.

“When babies are born, the umbilical cord is generally discarded. This is
partly because pregnant women and many of their doctors are unaware that
life science has demonstrated cord blood cells have immense therapeutic
value. Increasingly families are educating themselves about cryogenic
storage of their child’s cord blood because they understand recent progress
has revealed it is a safe and ethical source of stem cells for therapeutic
use and the technology is evolving rapidly. These cells can be
cryogenically stored for more than 30 years. It’s a one-time opportunity,”
said David Koos, Chairman and CEO of San Diego-based Bio-Matrix Scientific Group, Inc. (OTC Bulletin Board: BMSN; http://www.BMSN.us).

BMSN, an emerging research and development biotechnology company, opened its commercial cryogenic stem cell banking and processing facility in 2008. As of January 2009 BMSN has entered into contractual agreements with private stem cell preservation companies and other entities for the cryogenic banking and processing of stem cells from cord blood and peripheral blood of those companies’ donors’ specimens. BMSN does not have any contact with donor clients.

The Association of Family Cord Blood Banks estimated that about 750,000 cord blood collections are stored in private/family banks in the U.S., as of June 2008. The average cost of private cord blood banking in the U.S. for an individual is approximately $2,000 for the collection and about $125 per
year for storage, according to industry figures. There are often other fees
involved.

“Stem cell treatments from umbilical cord blood are one of the fastest
growing therapy groups, and proven clinically effective for conditions
including cancers, leukemia, and sickle cell anemia. In fact, stem cell
transplantation recently has overtaken bone marrow cell transplantation in
total number of treatments,” Young reported. “As these therapies become
more publicized, more effective, and more wide-reaching, the demand for stem cells will grow from two primary factors: increasing numbers of transplant patients, and increasing numbers of parents banking cord blood as a sort of ‘biological insurance.’” Young also noted integral in the growth of the cord blood banking industry is BioE Inc.’s PrepaCyte-CB product line, a new standard for cord blood processing, (http://www.bioe.com), which is positioned to become the dominant and default cord blood stem cell
processing technology.

Research Validates New Direction for Storage

An important discovery announced on March 25, 2009 by researchers at the National Institutes of Health (NIH; http://www.nih.gov), which has
implications for Leukemia treatment and artificially culturing blood cells,
validates a new direction for cryogenic stem cell storage facilities that
meet rigid state and federal regulatory requirements. The researchers
deciphered a key sequence of events governing whether the stem cells that
produce red and white blood cells remain anchored to the bone marrow, or
migrate into the circulatory system – a key discovery that will advance
understanding of how blood cells and immune cells are generated.

“The findings of NIH researchers have implications for culturing
infection-fighting immune cells outside the body, where they could be
temporarily held in storage during chemotherapy and other treatments which
suppress the immune system. This discovery confirms a new trend for
commercial cryogenic storage facilities for research and treatment of
diseases, and their important role in public and private stem cell research
efforts now and into the future,” said BMSN’s Koos. Describing BMSN as a
“conservative player in the stem cell industry,” he pointed out that the
company is developing a unique niche within the stem cell industry as a
place for stem cell companies to store blood specimens for research and
treatment of diseases.

While the concept of private cord blood banking started in the U.S. about 20
years ago, there has been tremendous growth worldwide in recent years. A
useful global educational web site dedicated to informing expectant parents
with unbiased and current information about how to choose a bank, and all
the issues involved, is Parent’s Guide to Cord Blood (http://www.parentsguidecordblood.org), based in Brookville, MD. The site
includes listings and snap-shot histories of each U.S. private and public
cord blood bank. There are also descriptions of 150 cord blood banks
located worldwide.

According to Young’s forecast: “Worldwide estimates show the market for cord blood processing and banking will grow by 25% over the next five years (approaching $450 million annually for cord blood processing), driven by surging demand in the U.S. and Western Europe (where an estimated
one-quarter of all newborns will have banked cord blood) and exploding
demand in India, China and Latin America – where processing is just
beginning to take off.”

Department of Defense Creates AFIRM

Research is well underway among participating institutions since the U.S.
Department of Defense announced in April 2008 the creation of a new $250
million institution focused on research called the Armed Forces Institute of
Regenerative Medicine (AFIRM). The virtual organization is a
multi-institutional, interdisciplinary network working to develop advanced
treatment options over the next five years for severely wounded service men
and women. AFIRM is managed and funded through the U.S. Army Medical
Research and Materiel Command (USAMRMC), with additional funding from the U.S. Navy, U.S. Air Force, the National Institutes of Health, the Veterans
Administration and local public and private matching funding.

AFIRM has been designed to speed the delivery of regenerative medicine
therapies to treat the most critically injured service members from around
the world, but in particular those coming from theaters of operation in Iraq
and Afghanistan. There are five major programs: Limb Repair, Craniofacial
Repair, Burn Repair, Scarless Wound Repair and Compartment Syndrome Repair.

AFIRM is made up of two civilian research consortia working with the U.S.
Army Institute for Surgical Research (USAISR) in Fort Sam, Houston, Texas.

One consortium is lead by Rutgers, The State University of New Jersey, and
the Cleveland Clinic and the other is led by Wake Forest University
Institute for Regenerative Medicine and The McGowan Institute for
Regenerative Medicine at the University of Pittsburgh. Each of these
civilian consortia is itself a multi-institutional network. There are a
total of 28 civilian institutions involved.

"Our researchers are continuing to pursue promising avenues, such as tissue regeneration of fingertips," said AFIRM Investigator William Wagner, Ph.D., Deputy Director of the McGowan Institute for Regenerative Medicine. "We are also testing in animal models materials that could replace damaged abdominal wall muscles, and we might soon embark on a novel strategy that uses muscle-derived stem cells to heal severely injured tissue."
(http://www.mirm.pitt.edu)

Dozens of commercial interests are expressing a willingness to work with the
AFIRM consortia as commercialization partners. The medical device industry has taken a keen interest in speeding these important new therapies to market, not just for injured service members, but for civilian patients as well. AFIRM believes this participation ultimately will lead to better
healthcare options for all Americans.

All of the research now being funded will use adult-derived stem cells taken
from the patient or from another consenting adult. AFIRM has stated adult
stem cells and progenitor cells are an integral part of normal wound healing
and the formation of all new tissues. Many of the strategies being
developed by AFIRM seek to improve wound healing and tissue repair by
increasing the number or improving the function of adult stem cells. A
patient’s own cells, or in some cases, cells from another adult, are used in
conjunction with special drugs called bioactive factors, or with advanced
biomaterials that serve as scaffold for growth of new tissues.

“The vision of the future is that before soldiers go off on operations they
will have their own stem cells harvested through liposuction and stored for
use if they get wounded. That way while a casualty is being stabilized
overseas, we will be in the U.S. growing them muscle, skin or bone ready for surgery,” Sgt. Glen Rossman of USAISR told Soldier magazine (March 2009 issue).

Project Director Col. Bob Vandre also commented: “AFIRM’s research is very exciting news and should be very reassuring to soldiers. Some day we will be able to fix a lot of things. We currently have 12 clinical trials ready
to roll and that is a sign that AFIRM has arrived and is very much for
real.”

Big Pharma Enter Arena
In what represents a major shift in the field, Pfizer announced in November
2008 it would spend $100 million over five years to develop therapies from
stem cells with the launch of Pfizer Regenerative Medicine
(http://www.pfizer-regenerativemedicine.com), a global unit based in
Cambridge, MA and Cambridge, the UK.

The U.S. unit is focusing on using stem cells to develop therapies for
cardiac disorders and cancer through in-house research and a vast array of alliances and collaborations, and will grow its team to 20 scientists. The
U.K. arm will grow to 60 scientists over the next two years with a focus
predominately on age-related and degenerative disorders with particular
interest in common cellular mechanisms and disorders of the central and
peripheral nervous system.

Pfizer Regenerative Medicine is operating as an independent research unit
and is basing its stem cell research and drug discovery efforts on a full
set of drug discovery capabilities.

Earlier in 2008, Pfizer invested $3 million with La Jolla, CA-based startup
EyeCyte, Inc. (http://www.eyecyte.com) to develop treatments for
diabetes-induced retinal damage, a leading cause of blindness, using patient blood and bone marrow-derived progenitor cells.

In addition, Epistem Plc (http://www.epistem.co.uk), the UK-based
biotechnology and research services company, announced in March 2009 that it had signed a research and development collaboration with Novartis to
identify new drug targets and therapeutics across a variety of disease
areas. Epistem, which is focused on the regulation of adult stem cells
located in epithelial tissue, is commercializing its expertise in the areas
of oncology, gastrointestinal and dermatological diseases.

Texas Bill Would Create Research Consortium

To further adult stem cell research on the state level, Texas Senator Jane
Nelson (R-Lewisville) and Chair of the Senate Health and Human Services
Committee, has authored Senate Bill 73 that would create the Adult Stem Cell Research Consortium, which would encourage collaboration between researchers at Texas universities and cord blood banks. This body would oversee funding for adult stem cell research received from both public and private sectors.

If passed, the bill would move Texas beyond the debate about whether it is
appropriate or inappropriate to destroy human embryos into the realm of
adult stem cell research and treatments without ethical concerns. It is
estimated that more than 1.2 million Texans are afflicted with chronic
degenerative conditions and can benefit from this research that could lead
to the discovery of successful treatments and potential cures.

During March 2009 Texas Medical Association physician leader James T.
Willerson, MD, who is President and Medical Director of Cardiology Research, and Codirector of the Cullen Cardiovascular Research Laboratories at Texas Heart Institute in Houston, and other authorities in the state’s adult stem cell field testified before senators at the Texas Senate Health and Human Services Committee meeting in Austin in support of Senate Bill 73.

Cord Blood Advancements Since 1st Transplant
In cord blood technology, 2008 marked the 20th anniversary of the first cord
blood transplantation in the world, carried out by Eliane Gluckman, MD,
Ph.D. The recipient of that pioneering effort, Matthew Farrow, now 26 years
old, continues in good health. He was born with a rare blood disorder and
was expected to die before the age of 10. When he was five his parents took part in a pioneering experiment in France to use stem cells from his sister’s umbilical cord when she was born.

Since then, cord blood stem cells have been used in more than 14,000
transplants worldwide to treat more than 70 diseases in both adults and
children and are now showing great promise for regenerative medicine
applications, including treatment for type 1 diabetes, brain injury,
cerebral palsy and hearing loss, according to Cord Blood Registry
(http://www.cordblood.com), the world’s largest stem cell bank.

“As a result of pioneering work and the tremendous progress over the years, for many families cord blood banking is the best option for treating and curing disease, especially as they understand the importance of umbilical cord donations for advancing the science,” said Koos of Bio-Matrix
Scientific Group.

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