For Patients Seeking Cures, Adult Stem Cell
Research Industry is Blossoming

by Sally Robbins
April 6, 2009

LifeNews.com Note: Sally Robbins is an author and freelance writer whose writing credits include Forbes, Business Week, Tribune Media Services, Market Watch, Advertising Age, and New York Daily News. She recently completed an historical novel, Rivaling Paris, and is at work on a biography about Henri Bendel.

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.”

Adult Stem Cell Research Blossoming, (continued)