Cenegenics Carolinas, a preventive health and age management medical facility, will begin offering stem cell collection and storage services for adults. It will do so through a partnership it has formed with Florida-based AssureImmune, one of three companies in the U.S. that collects and preserves adult stem cells.

Staff Report
Published Jan. 27, 2009

Cenegenics is the only facility in the Carolinas to offer the service. Cost for the procedure is $3,395 per person and includes four years of storage. After four years, storage costs range from $219-$349 per year, depending on the amount of time prepaid.

“At Cenegenics, we help our patients maximize their health and quality of life, which also helps improve the quality of their stem cells,” said Dr. Mickey Barber, CEO of Cenegenics Carolinas. “What better way to further protect our future health than to offer this breakthrough technology that is as simple as collecting blood but provides health ‘insurance’ for our future.”

Stem cells are cells within the body that have the potential to become any cell, organ or tissue, thus making them valuable for any number of medical purposes, such as curing disease or facilitating research.

Whereas the controversial embryonic stem cells are essentially blank slates that can become anything, adult stem cells are found within major organs or tissues and are generally limited to that type of cell. For example, some adult stem cells function to form all the types of blood cells in the body, others form all the bone and cartilage, and still others form the nerves in the brain.

According to the National Institutes of Health, scientists have found adult stem cells in the brain, bone marrow, peripheral blood, blood vessels, skeletal muscle, skin and liver.

AssureImmune collects adult stem cells, a relatively new technology, from the peripheral blood of adults and older children, as well as stem cells from the cord blood of newborns.

As one of the few stem cell banks in the world to use automated, computer-controlled equipment for the processing and storage of the samples, AssureImmune is able to recover more viable stem cells from each sample. Additionally, it is the only company that produces duplicate samples and stores them at different locations for backup security.

(BioWorld Today Via Acquire Media NewsEdge) Q&A: Robert Lanza

Google.com/news, January 27, 2009 — With the recent swearing in of new President Barack Obama there is much anticipation that the U.S. government will be more supportive of embryonic stem cell (ESC) research. In our first BioWorld Q&A feature, we spoke with Robert Lanza, chief scientific officer of Advanced Cell Technology and chief scientific advisor for Worcester, Mass.-based International Stem Cell & Regenerative Medicine International, a recently formed joint venture between ACT and CHA Biotech.

BioWorld: Why was this joint venture created?

Lanza: It will initially develop human blood cells and other clinical therapies based on ACTC’s proprietary hemangioblast cell technology. It holds the exclusive license to all of ACT’s hemangioblast technology. It is anticipated that this technology may some day help address the critical care shortage of blood for emergency situations, including military needs. The technology also has been shown to repair vascular damage in animals after heart attacks, limb ischemia and diabetes.

BioWorld: What are the major issues facing stem cell researchers today?

Lanza: One of the major issues is the problem of tissue rejection. To date, there is no way to transplant replacement cells derived from ESCs into a patient without powerful immunosuppressive drugs, which of course, are associated with cancer, infection and a long list of other serious side effects. In fact, the need for systemic immunosuppression could make the treatment worse than the disease. This is why we are focusing on “universal” blood, platelets and diseases that involve immune-privileged sites, such as the eye. Another major problem: You need to have a source of cells that is readily available, safe and that can be generated on a large scale. Unfortunately, it turns out that only a few replacement cell types can – at least at present – be reliably generated from hESCs. Assessment of safety and efficacy also are critical before hESC therapies can move into the clinic.

BioWorld: With restrictions on federal funding under President Bush, many researchers headed overseas and there was concern that the U.S. was losing talent and momentum. Do you see this changing under President Obama?

Lanza: Yes, all of this will change under President Obama. His inauguration marks the end of a sad chapter in American scientific history – where laws were passed that actually criminalized scientific research. As you know, the Bush administration has had an adversarial relationship with the scientific community (bordering on being antiscience). The new U.S. leadership (both the White House and Congress) will hopefully now listen to advice from the medical and scientific community (rather than taking sides in religious debates). The black cloud that has hovered over stem cell research in the United States has finally been lifted. We have been operating for the last decade with one hand tied behind our back. Under the new Obama administration, money will hopefully flow to all promising avenues of research based on scientific merit (and not skewed to fit a conservative Christian agenda). This extends not only to NIH and SBIR grants, but to NIST and even to DARPA grants. The impact on the private sector is equally critical. The day after Obama was elected, investors started to come out of the woodwork. For instance, we were on the verge of bankruptcy, and did an about-face as soon as Obama was elected.

BioWorld: How far away are we from having meaningful therapies for patients?

Lanza: As far as ESCs, there are really only two companies on the verge of clinical trials – ACT and Geron. We’ve already had our official Pre-IND meeting with the FDA. They seemed happy with our data and clinical plans. We hope to file an IND to begin clinical trials to prevent blindness by summer. We still have a few studies to complete, but everything looks great so far. Of course, the field desperately needs a big clinical success. We have developed a technology to treat degenerative eye diseases such as macular degeneration. We have demonstrated that these hESC-derived cells can rescue visual function in animals that otherwise would have gone blind.

BioWorld: Last week, Geron became the first company to get FDA approval to begin a Phase I trial of an ESC product, GRNOPC1, to treat patients with spinal cord injury. (See BioWorld Today, Jan. 26, 2009.) Is this a clear sign of things to come for the field?

Lanza: This is a huge advance for the entire field – my hat is off to them. This is what we’ve all been waiting for. It has been over a decade since ESCs were first discovered. This sends a message that we’re ready at last to start helping people. Again, we are planning to file an IND with the FDA to begin clinical trials to prevent blindness this summer. Sometimes, it’s the second mouse that gets the cheese. Now that the FDA is comfortable with the safety of ESC therapies, all eyes will be looking for results. That is, can you really treat or cure a disease? Of course, it’s extremely important that Geron does well in this trial. It could be a disaster if something goes wrong. Remember what happened with gene therapy. They shut everyone down.

BioWorld: What sort of advantage does your technology offer?

Lanza: In addition to generating “universal” blood, there are also advantages of using retinal cells to treat blindness and eye disease. We have been able to consistently and reliably generate retinal cells – known as “retinal pigment epithelium” (or RPE) – from every hESC line we have studied. These cells have been extensively characterized and have all the markers and behavior of normal retinal cells. The retinal pigment epithelium is an important eye tissue, which plays a critical role in the pathogenesis of macular degeneration, retinitis pigmentosa and other retinal degenerative diseases. In the RCS rat, improvement in visual performance was 100 percent over untreated controls without any apparent adverse effects. In untreated animals, the layer of cells the animals see with was only one layer deep after 100 days. However, in the treated animals, the cells were five-to-seven cells deep! Of course, control sham-treated eyes showed no improvement.

BioWorld Q&A is a periodic feature that profiles industry leaders and particular companies, or serves as a sounding board for a variety of issues. If you have suggestions for a particular subject, send your emails to newsdesk@bioworld.com.

Obama Brings Hope to Stem Cell Research


By Heather Ishimaru

ABCNEWS.COM, President-elect Barack Obama has promised to end federal restrictions on stem cell research. A lot of advocates are eagerly waiting for that to happen because they believe stem cell research could help cure them.

Eight years ago the Bush administration all but ended stem cell research by restricting federal financing.

California voters kept the work alive here with passage of Proposition 71, which provided state funding for stem cell research. But Obama has promised to clear the way for federal funding once again. It’s the best news Fremont resident Roman Reed has had in eight years.

It’s so exciting, the hope. I just feel renewed energy knowing that Barack Obama cares, knowing that we’re going to be able to put aside the past-partisan stem cell politics. We’ll actually be able to put the research first… care about the people that are suffering,” said Reed.

Reed was a promising 19-year-old Chabot College linebacker when a tackle broke his neck and changed his life. Now 34, Reed has use of his hands. He has two children with a third on the way, and he now has new hope that stem cell research will help him walk again.

“When you’re dealing with complicated pioneering research, it is fits and starts. So we don’t know exactly when the cures will come, but the cures will come down the road,” said Reed.

Stem cells hold promise for curing all kinds of diseases. The most promising results require embryonic stem cells. Scientists get them from frozen embryos that would otherwise be thrown away.

The Vatican just reaffirmed its opposition to stem cell research in a document released last month. It refers to an embryo as a “human being in his or her embryonic state,” not a cluster of cells subject to “utilitarian treatment” in a lab.

Terry Thompson is with the Life Legal Defense Foundation. He says Obama will not be walking a fine line on this one.

“I don’t think it’s a fine moral line, I think it’s a real bright red line. On one side you’re going to do research that kills embryos, and on the other side you don’t do it,” said Thompson.

Harvard Medical School, January 27, 2009, by Howard Lewine — I have a recurring problem with the skin at the corners of my mouth. The skin gets irritated with small cracks. It gets better, then for no apparent reason, the problem returns. What could be causing this condition? Can I prevent it from happening again?

This condition is called angular cheilitis, also know as angular stomatitis or perleche. The skin cracking at the corners of your mouth can be associated with redness and scaling. The cause is frequent or persistent saliva touching the skin outside the mouth. This can occur because of a poor seal of your lips at the angles of your mouth, braces, ill-fitting dentures or because you frequently lick the area. Less commonly, this can be the result of an allergic skin reaction to lipstick or face cream, or too vigorous dental flossing. The cause of angular cheilitis could also be a vitamin or iron deficiency, but that’s rare.

The cracks in the skin and the excess moisture provide a fertile environment for yeast. The yeast causes a low-grade infection, which may make the corners of the mouth even more irritated.

While the angular cheilitis is active, you can apply an over-the-counter antifungal cream, such as clotrimazole, then topical hydrocortisone 1 percent ointment an hour later. You can do this two to three times a day. Another option is a cream containing both hydrocortisone and the anti-infective agent iodoquinol (Vytone, also available as generic).

To help prevent a recurrence, don’t lick your lips. You want to avoid letting excessive moisture accumulate in the corners of your mouth.

Once the angular cheilitis heals, use a protective lip balm, preferably one that is hypoallergenic. Make sure the mouth corners are dry before applying, and use it often.

If the condition does not clear, see your physician for a prescription anti-yeast cream such as ketoconazole cream.

Cracks in the skin and the excess moisture provide a fertile environment for yeast, which causes a low-grade infection.

The New York Times has an article on the rise of new R Language. Started as an open source programming language for data analysis, its popularity and use is spreading to major companies as diverse as Pfizer, Merck, Google, Shell, and Bank of America.

One company that’s being affected is SAS. With $2 billion plus in annual revenue, the rise of R can seriously affect their business, especially when new researchers and graduates are making the switch. The article reports:

“R has really become the second language for people coming out of grad school now, and there’s an amazing amount of code being written for it,” said Max Kuhn, associate director of nonclinical statistics at Pfizer. “You can look on the SAS message boards and see there is a proportional downturn in traffic.”

SAS says it has noticed R’s rising popularity at universities, despite educational discounts on its own software, but it dismisses the technology as being of interest to a limited set of people working on very hard tasks.

Anne H. Milley, director of technology product marketing at SAS, has been quoted “We have customers who build engines for aircraft. I am happy they are not using freeware when I get on a jet” referring to R. The problem is, the SAS itself is written on freeware. Both C and C++ are freeware. How happy is she now?

R programming language offers something that most of current languages do not support well, parallelism. With a package named “SNOW”, R can take advantage of multiple cores in the CPU. Due to the limitation in increasing CPU’s clock speed, Intel and AMD are stuffing more cores into the processors. There aren’t many software in the market that can take advantage of this, but R is.

NYT Link: http://www.nytimes.com/2009/01/07/technology/business-computing/07program.html?partner=permalink&exprod=permalink
R link: http://www.r-project.org/

Greatest ROI Opportunity for Consumers in Shortest Period of Time

WASHINGTON, Jan. 27 /PRNewswire/ — As the new administration examines the potential investment in targeted therapies that utilize personalized medicine to improve patient care, a new report released today by the Deloitte Center for Health Solutions found significant opportunities for the adoption of personalized medicine to produce a positive return on investment across key stakeholders in the U.S. health care system. The report, released today at the Personalized Medicine Coalition conference, “Achieving ROI in Personalized Medicine: Barriers, Incentives and Pathways to Successful Commercialization,” also found that consumers stand to gain the most significant ROI opportunity within the shortest time period.

“Personalized medicine is not a promise of the future; it is fast emerging as the current state in diagnostics and therapeutics,” said Terry Hisey, vice chairman and U.S. industry leader for Deloitte LLP’s Life Sciences industry group. “The U.S. health care system will confront an array of challenges to expedite development to make personalized medicine a reality. Our report examines opportunities to overcome these obstacles, from access to capital to stimulate increased R&D to how to justify coverage by health plans often pressured for short-term savings.”

Assessing the barriers and incentives for advancing the adoption of personalized medicine, the Deloitte report, “The ROI for Targeted Therapies: A Strategic Perspective,” provides an analysis of personalized medicine’s economic value proposition. It examines the importance of ROI for multiple stakeholders — consumers, diagnostic companies, pharmaceutical and biotechnology companies and payors.

Deloitte developed a framework that factored in the ROI for personalized medicine by examining case studies categorized by two scenarios — altering the course of therapy or introducing a companion therapy — across a number of clinical conditions, ranging from HIV/AIDS to breast cancer. The results of the analysis found that the ROI and time to yield benefit varied by scenario across each stakeholder group.

According to the report:

  • The literature review of two clinical scenarios found that all stakeholder groups experienced a positive ROI under certain conditions.
  • Consumers consistently experienced a positive ROI across all scenarios.
  • Payors received only a marginal benefit, and that was after six years.

“Personalized medicine facilitates better care and lower costs, and has the potential to benefit every major stakeholder in the U.S. system — most importantly, its patients,” added Paul Keckley, Ph.D., executive director of the Deloitte Center for Health Solutions.

Highlights of key stakeholder implications found in the report include:

  • Consumers stand to gain the greatest ROI from personalized medicine, often within the first year. However, upfront costs will likely be required because these therapies may be more expensive than conventional treatments. Long-term benefits of personalized medicine create an incentive for adoption, although education will also be critical to help consumers make informed care decisions.
  • Providers will benefit from the new tools offered by personalized medicine to improve patient care; however, reimbursement issues will need to be worked out with payors. Additionally, as providers implement electronic health records, new decision-support tools will help facilitate the adoption of disease-specific standards of practice that can provide real-time data to help prioritize therapies based on potential drug interactions and patient clinical profiles.
  • Payors may want to factor in personalized medicine products into the equation as the employer-sponsored model evolves into a retail health insurance model, providing the opportunity to include customized products. Plans may also benefit as personalized medicine may help slow the advancement of conditions and diseases that, left untreated, result in more expensive acute care interventions and institutional care. Additionally, they may also desire government subsidies, premium tax reductions and abatements to make coverage of personalized medicine more profitable.
  • Policy makers will need to consider incentives for commercial health plans to adopt personalized medicine by leading by example (for example, reimbursing these technologies). They can also consider leveraging the connection between personalized medicine with the Orphan Drug Act, as well as supporting R&D tax credits (or other strategies) for the biotech/pharma industry to encourage its personalized medicine development efforts.
  • Biotech/Pharmaceutical and diagnostic companies may need to consider more virtual R&D to address smaller markets with more targeted therapies to reduce R&D expenditures, as well as collaborate with affiliates, such as academic medical centers and research organizations. The continued trend toward M&A and partnerships may also pick up as personalized diagnostic companies may become prime investments or acquisition targets. New strategies to integrate marketing, sales and distribution with companion diagnostics will need to be considered to improve the cost effectiveness of these activities.

Target Health is actively involved in the Clinical Trial Transformation Initiative (CTTI). The goal of the CTTI is to optimize the clinical trial process and to eliminate the infinite number of myths common to the clinical trial and regulatory community. The CTTI mandate is to identify existing issues related to current practice, design models for improvement, and to test the new models and compare them to existing processes. Target Health will contribute its extensive experience in clinical trials and regulatory affairs and its cutting edge paperless clinical trial toolbox (21st Century technology) to the CTTI. Target Health’s proprietary clinical trial software, enables our customers to switch from paper to the the digital world and at the same time accelerate time to market, increase productivity and save money.

For more information about Target Health or any of its software tools for paperless clinical trials, please contact Dr. Jules T. Mitchel or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors

FDA has launched of a voluntary 2-year pilot program that would help promote the safety of drugs and active drug ingredients produced outside the US. FDA plans to select 100 applicants to participate in the Secure Supply Chain pilot program. The goal of the pilot is to allow FDA to determine the practicality of developing a secure supply chain program. Such a program would assist the agency in its efforts to prevent the importation of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the program and that may not be compliant. It will also expedite the entry of products meeting the pilot’s criteria into the US. The pilot was developed with input from U.S. Customs and Border Protection and other stakeholders. Information about the pilot appears in a Federal Register notice. The way it works is that each applicant may designate up to five drugs for selection in the pilot program. To qualify, applicants will need to meet the pilot’s criteria, including a requirement that they maintain control over the drugs from the time of manufacture through entry into the US. A secure supply chain will help mitigate risks such as contamination and counterfeiting. Applications for participation in the pilot program will be processed in the order received. Companies wishing to participate in the two year pilot program must meet certain criteria, including:

* For finished drug products, the applicant must hold an FDA-approved drug application or must be the foreign manufacturer identified in an FDA-approved application;
* The active pharmaceutical ingredients imported must be used only to make FDA approved drugs;
Foreign drug manufacturers and U.S. establishments receiving drugs must be FDA-registered and comply with Good Manufacturing Practices; and
* Applicants must show that their drug products use a secure supply chain.

For more information about our expertise in Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.

Patients with spinal cord injuries will be first 1) ___ to receive repair cells derived from embryonic stem cells. The first ever clinical trial using stem cells derived from embryonic stem cells (ESCs) received the go-ahead, from the FDA on January 23, 2009. Geron Corporation, a company based in Menlo Park, California, hopes to mend the spines of patients paralyzed from the chest down by 2) ___ injury sites with stem cells that restore connections and repair damage. This marks the beginning of what is potentially a new chapter in medical therapeutics, one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells. The trial had been “on clinical hold” for years over concerns that the cells could form 3) ___, but the FDA is now satisfied that this risk is low enough to allow the trial to proceed. Ethical concerns have also dogged the trial, because obtaining the cell lines involved destruction of embryos. US president, George Bush, had prevented research using such cells for eight years. The new president, Barack Obama, promised in his inaugural address to “restore science to its rightful place”, so approval of the trial could be an early sign that he will lift all of the previous restrictions on stem-cell research, first imposed in 2001. Hundreds of trials are already under way around the world with stem cells derived from adult or 4) ___ tissue, but these cells are limited in the types of tissue they can turn into and repair. The spine repair trial could open up a new era in medicine because embryonic stem cells are the only type that generate all 200 or so 5) ___ of the body. Geron says that the main objective is to prove the cells are 6) ___, especially given the FDA’s earlier misgivings over the cancer risk. But for one year after treatment, the company will also look closely for any recovery of function and movement in the lower 7) ___ lost through the injury. In all, the patients will be monitored for 15 years. If the cells appear safe, it could open the floodgates for a host of other trials using cells originally derived from ESCs. Geron itself has developed such cells for treating heart attacks, diabetes, bone damage, arthritis, liver failure and 8) ___.

ANSWERS: 1) humans; 2) injecting; 3) tumors; 4) fetal; 5) tissues; 6) safe; 7) body; 8) cancer

Embryonic stem cells are blank cells found in embryos, which have the ability to turn into any cell in the body.

Embryonic stem cells are blank cells found in embryos, which have the ability to turn into any cell in the body.

CNN.COM, January 23, 2009, by Miriam Falco — — Federal regulators have cleared the way for the first human trials of human embryonic stem-cell research, authorizing researchers to test whether the cells are safe to use in spinal injury patients, the company behind the trials announced Friday.

The tests could begin by summer, said Dr. Thomas Okarma, president and CEO of the Geron Corporation. The Food and Drug Administration has approved the trials, which will use human stem cells authorized for research by then-President George W. Bush in 2001.

The patients will be those with the most severe spinal cord injuries, called complete spinal cord injuries.

“A complete spinal cord injury has no hope of recovery below the injury,” Okarma told CNN. “This is significant because it’s the first clinical trial of a human embryonic-based product.” The primary purpose of the trial will be to see whether injecting these cells into patients is safe, but Okarma said researchers will also look for any signs of recovery. Scientists will monitor the patients for a year after the injections to see if they are regaining any function below the injured point.

“If there is any movement below the injury, they will measure that and record it,” he said.

The trials will involve eight to 10 patients who are completely paralyzed below the third to tenth vertebra, and who sustained their spinal cord injury within seven to 14 days. The tests will use stem cells cultured from embryos left over in fertility clinics, which otherwise would have been discarded.

Using the stem cells, researchers have developed cells called oligodendrocytes, which are precursors to nerve cells and which produce a protective layer around nerve cells known as myelin. Researchers will inject these nerve cells directly into the part of the spine where the injury occurred.

Embryonic stem cells are blank cells found in four- to five-day-old embryos, which have the ability to turn into any cell in the body. However, when stem cells are removed, the embryo is destroyed — which has made this one of the most controversial medical research fields in the past decade.

Federal research funds were prohibited for embryonic stem-cell research until August 2001, when Bush approved spending for research using only already-existing cell lines. Scientists later discovered that fewer than two dozen of those lines were useful for research, but abortion opponents opposed any legislation that would lift Bush’s restrictions, and Bush twice vetoed congressional efforts to roll back his rules.

President Obama is expected to loosen the restrictions, which many researchers and advocates have complained severely set back work toward curing disease such as Alzheimer’s, Parkinson’s and diabetes.

Okarma said Geron did not use any federal funding for its research, and that the Bush restrictions had “devastated the field.”

“People didn’t think this would happen for another five years,” Okarma said. “But it will happen soon, and it would have happened sooner if it weren’t for the ridiculous Bush policies.”

Geron owns patents on and licenses the procedure to make these stem cell lines. The company spent $45 million of its own to produce everything required to get approval for the upcoming trial, Okarma said.

At least two other companies have said they plan to begin conducting embryonic stem-cell tests in humans, but only Geron has received FDA approval. Another U.S. company, Reneuron, plans to conduct trials involving stem cells taken from fetal tissue in Britain this year. Other companies have developed stem cells from adult tissue, sidestepping the controversy.

In addition to producing stem cells to treat spinal cord injuries, Geron says, it has seven other types of cells derived from stem cells in its pipeline. Okarma said FDA scrutiny was stringent, and that researchers studied the cells in petri dishes and in animals before obtaining permission to test them in humans.

Getting approval was made harder and took longer because the FDA had no other peer-reviewed research outside of Geron’s to consult as it reviewed the proposal, he said.

The trials are not expected to start until summer, because many of the preparations could not begin until Geron had FDA approval, Okarma said. Researchers have to be educated about how to use the stem cells, how to prepare their laboratories for the research and how to read all the magnetic resonance imaging (MRI) of the patients in the same way.

“We [also] have to train surgeons how to inject the stem cells,” Okarma explained. His company even developed a device that is mounted to the operating table to help surgeons inject the stem cells.

Geron still has to select the four to seven sites for the clinical trials, Okarma said.

The first human embryonic stem cells were developed by Jamie Thomson at the University of Wisconsin-Madison in 1998.



Graphic: stem-cell treatment for spinal injuries
(David Scharf/Science Photo Library)

Therapies based on human embryonic stem cells could be used to treat paralysis, Parkinson?s disease and diabetes

The UK Times.com, January 23, 2009, by Mark Henderson — Paralysed patients will this summer become the first people in the world to receive a therapy based on human embryonic stem cells, in a study that promises to open a new era for medicine, The Times has learnt.

The first human trial of the technology, which has huge potential to cure disease yet is considered unethical by “pro-life” groups because it involves destroying embryos, will today be cleared to proceed by US regulators.

The decision marks a sea-change in US government attitudes to stem cells, as President Obama prepares to lift restrictions imposed by President Bush that hampered progress in the field. Mr Obama pledged in his inaugural address to “restore science to its rightful place”, and to end White House obstruction of stem-cell research.

Today’s ruling by the Food and Drug Administration (FDA) will allow doctors to inject specialised spinal cells grown from embryonic tissue into patients who have just become paralysed from the chest down. It is hoped that the cell transplants will prompt regrowth of damaged nerves, restoring sensation and movement to people who would otherwise have been paralysed for life. The treatment will be used on people a week or two after they suffer their spinal injury; it cannot help those already paralysed.

A successful trial would transform the prospects of thousands of people for whom few treatment options currently exist. If results are positive, the therapy could be approved for wider use within three to five years.

Thomas Okarma, chief executive of the Geron Corporation, which developed the treatment, said: “This marks the beginning of what is potentially a new chapter in medical therapeutics — one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function by the injection of healthy replacement cells. The ultimate goal is to achieve restoration of spinal cord function.”

Embryonic stem cells are master cells found in human embryos, which give rise to more than 200 specialised types of tissue in the adult body. They have vast medical potential, because the can be grown into any kind of tissue to replace cells damaged by injury or disease. Stem-cell therapies could eventually be used to treat conditions such as diabetes and Parkinson’s disease, as well as paralysis.

Use of embryonic stem cells, however, is contentious because they must be harvested from human embryos, which are destroyed in the process. This has raised moral objections from those who believe embryos have the same rights as living people and see the technology as unethical.

The issue is especially acute in the US, where it has become entwined with the fraught politics of abortion. Opposition to stem-cell research is led by the evangelical Christian lobby, whose influence prompted President Bush to ban most federal funding in 2001 — the Geron work was financed entirely by the private sector. Stem cell research is legal in Britain, where it is encouraged and funded by the Government.

Though the FDA is independent of the White House, the timing of its backing for the Geron trial is symbolic of the Obama Administration’s fresh approach. The new President is expected to start unwinding the funding ban as early as next week.

Polls suggest that most Americans support stem-cell research, and Congress has voted for more federal funding, but in 2006, President Bush used his first veto to block a Bill that would have delivered this. Dr Okarma said: “The people who will take part in our trials are currently walking around, like you and me. But the delay caused by the White House has meant that there are people out there who might have benefited, but who now cannot.”

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