Stem Cell Clinic

Medical Council okays 11 stem-cell studies

By Stem Cell Treatment

Home national Medical Council okays 11 stem-cell studies

Health

Chularat Saengpassa, Pongphon Sarnsamak The Nation October 23, 2012 7:38 pm

But the council has approved only 11 studies, which will include research into the most common diseases such as diabetes, arthritis, retina irregularities and the spinal chord, Dr Somsak Lohlekha, who chairs the council's stem-cell research regulatory panel, said.

Separately, the council has been asked to certify two other studies related to heart disease as standard treatment, but it has put them on hold due to opposition from Thailand's Royal College of Physicians and Royal College of Surgeons.

"These two medical colleges found that patients with heart disease did not feel any better after getting stem-cell injections," Somsak said.

Moreover, stem-cell treatment for heart disease had yet to be accepted by the international medical community as standard treatment.

"We found that many patients spent more than a million baht for this treatment and their condition did not improve," he said.

Of the 11 stem-cell studies approved by the council, one is being conducted at the Police General Hospital. The research team, led by Pol.Mai.Gen Dr Thana Turajane, has succeeded in developing adult stem cells derived from blood that can develop into cartilage tissue and be used to treat arthritis. It can also be used to culture a new set of stem cells.

Thana and his team had to wait more than nine months for a go-ahead from the Medical Council. In their application, they included a report on animal trials done by a Malaysian university to show that the use of stem cells was safe.

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Medical Council okays 11 stem-cell studies

Houston company ceases supplying stem cells

By Stem Cell Treatment

Under fire from the Food and Drug Administration, the Houston-area company that facilitated Gov. Rick Perry's controversial 2011 stem-cell treatment has stopped providing doctors with the cells patients banked at its facility for the procedure.

In a response to an FDA warning that it is acting illegally by marketing the unlicensed therapy, Celltex Therapeutics Corp. wrote the federal agency this week that it has ceased enrolling patients in the clinical trials the state requires of stem-cell providers. Celltex was the Houston area's primary sponsor of such for-profit trials.

"We're telling potential patients that we will still bank their stem cells and will enroll them in trials once new investigational drug applications have been submitted and reviewed by the FDA," said Amdrea Ferrenz, Celltex's executive vice president and legal counsel. "We hope that will be in a matter of months."

Ferrenz called the FDA warning letter, publicly posted Tuesday, "a disappointment" but said it actually just moves up Celltex's plan to move into agency-approved trials targeting specific disease conditions. The Sugar Land company had been operating for nearly 18 months facilitating adult stem-cell procedures with little regulation.

The Texas Medical Board in July began requiring that any stem-cell procedure be reviewed for patient safety by a board expert at such evaluations. The board used by Celltex, Texas Applied Biomedical Services, last month received an FDA warning letter of its own, informing it the agency will withhold approval of all its reviews because of problems with the review board's operations, such as members with conflicts of interest.

FDA warning letters are considered big deals in drug regulation, the federal agency's principal means of achieving compliance. They include language that failure to take corrective action can result in company seizure or shutdown.

It is unclear if the FDA letters to Celltex and the review board will have an effect on the new medical board rules, meant to regulate the experimental therapy in the absence of oversight from the FDA. A medical board spokeswoman said this week that the board could reopen the matter at its November meeting.

Leigh Turner, a University of Minnesota bioethicist who writes frequently about stem-cell tourism and in February complained to the FDA that Celltex is "a potential danger to patients" and not in compliance with federal law, said he thinks it's "highly unlikely" that Celltex could quickly meet FDA requirements for research trials. He said Celltex would need to make a dramatic reconfiguration considering all the deficiencies an FDA inspection found in April.

Those included numerous basic manufacturing problems, all reiterated in the warning letter. Ferrenz said Celltex is eager to meet with FDA officials to learn what they still want to know beyond the "tons of information" the company has already sent.

Celltex had argued stem-cell injections are like bone marrow transplants and not subject to the FDA's jurisdiction. But in its warning letter, the FDA said Celltex's processing "alters the original relevant characteristics" of the cells and hence doesn't meet its requirement that living cells only be "minimally manipulated." It categorized the stem cells stored and treated at Celltex as biologic drugs.

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Houston company ceases supplying stem cells

Stem cell therapy for muscle, sports injury alternative to surgery

By Stem Cell Treatment

By Erika Sauler Philippine Daily Inquirer

MANILA, Philippines This type of stem cell therapy does not claim to be the fountain of youth, but an alternative treatment to arthritis, muscle pain and tendon tear.

Two Filipino doctors who trained in the United States said in a media forum on Sunday that autologous stem cell therapy could speed up the healing of musculoskeletal and sports-related injuries, which could be an optional remedy before undergoing surgery.

Dr. Jeimylo de Castro explained that the procedure would involve taking stem cells from the patients blood, fat tissue or bone marrow and injecting them to the injured area of the same person. This type of therapy is different from the controversial embryonic stem cells which are harvested from animals or fertilized eggs.

With stem cell therapy being a current fad for anti-aging, the Department of Health has warned the public that the benefits of stem cell therapy are still under evaluation. The DOH will soon issue guidelines for the use of stem cell therapy and the licensing of facilities offering this service.

De Castro and Dr. Franklin Domingo are both fellows of the Philippine Academy of Rehabilitation Medicine. They underwent training for stem cell therapy under Dr. Joseph Purita of the Institute of Regenerative and Molecular Orthopaedics, and Dr. Sherwin Kevy of Harvards Immune Disease Institute.

If you have arthritis and you take anti-inflammatory drugs, you will not feel the pain so you will move around and further damage the cartilage. Whereas stem cells will regenerate tissues and ease the pain, making the damaged cells become young again, De Castro said.

Domingo likened the stem cells to high school students who have no career yet and could be trained to be professionals in a field where they are needed. So if the stem cells are injected into an injured knee, they will develop into tissues that hasten the recovery of the area.

According to Domingo, stem cell therapy is not for everybody and is not a quick-fix solution because it uses the bodys natural ability to heal.

Patients who have cancer and infection are not allowed to undergo stem cell therapy, and so are those under the influence of alcohol or who have taken blood-thinning medicine like Coumadin at the time of extraction.

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Stem cell therapy for muscle, sports injury alternative to surgery

Stem cell meeting takes on national, international flavor

By Stem Cell Treatment

La Jolla's annual meeting about stem cells was once about stem cell science in San Diego, largely presented and attended by stem cell scientists in San Diego. But the Stem Cell Meeting on the Mesa has grown to take on a national, or even international, flavor.

Along with the growing emphasis on commercializing regenerative medicine research, companies in the field are hunting for corporate partners. And to reach the right people, they're willing to travel far.

Of 35 companies and institutes presenting their technology Monday and Tuesday at the Sanford Consortium for Regenerative Medicine, just five are headquartered in San Diego County; 10 are headquartered elsewhere in California and 18 are from other states, along with one from the United Kingdom and one from the Netherlands.

Other companies have sent representatives to scout partnering opportunities.

The Stem Cell Meeting on the Mesa provides a focus on regenerative medicine hard to get in other conferences, said Alexander Vos, chief executive of PharmaCell, based in Maastricht, Netherlands. The company provides contract human cell and tissue culturing services.

"It makes (discussions) much more effective," Vos said. "There are clearly other conferences as well, for instance the larger BIO (Biotechnology Industry Organization) meeting, but that covers all segments of the biotechnology industry, so there regenerative medicine is a small part. Here, it's a very focused meeting."

Closer to home, Cedars-Sinai Regenerative Medicine Institute in Los Angeles presented its technology along with the 34 other institutions, each given 15 minutes to make their "elevator pitch" to pique investor interest. Director Clive Svendsen said the institute is getting into "translational" research, which requires a business partner to get the treatment to patients. The meeting is well-suited to that goal, he said.

Svendsen said the meeting was made even more attractive because of the role of the state stem cell institute in organizing it. The California Institute for Regenerative Medicine, which has been awarding grants for basic research, has recently starting giving out more money for translational medicine. Last week it gave a $10.1 million grant to help San Diego's ViaCyte bring a diabetes treatment to market.

In July, the Cedars-Sinai Regenerative Medicine Institute was awarded a $17.8 million CIRM grant to develop treatments for ALS, also known as Lou Gehrig's disease.

Svendsen said he's had good discussions at the meeting, including one with a company that has developed a method of tracking stem cells once they're transplanted into the body. That's desirable to make sure the cells actually survive after transplantation, he said.

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Stem cell meeting takes on national, international flavor

Perry brings his stem-cell cause to Houston

By Stem Cell Treatment

Gov. Rick Perry pushed Friday for Texas to become the center of adult stem-cell therapy, disregarding the federal government's increasing crackdown on clinics marketing the experimental medicine.

Perry told a crowd of stem-cell researchers, industry leaders and patients gathered in Houston that the young science "holds the promise of miracles" desperately needed by people across the world and suggested Texas' "wildcat spirit" and "conducive climate" can make it happen here.

"I'm not shy about asking people to relocate or start up their companies in Texas," said Perry, likening stem-cell treatment to previous innovations in space and heart care. "All of you outside the state of Texas - come on in. The water's fine. We've got an amazing environment here."

Perry, who famously got the unlicensed treatment for an ailing back in 2011, said the state has made sure that innovators won't be "hindered by exorbitant taxes, wrapped up by bureaucratic red tape or at the mercy of predatory attorneys, seeking to make steady money off extensive, drawn-out court cases."

Perry's remarks, made at the first of a planned annual Houston conference, came as the state appears headed toward a collision with the Food and Drug Administration, which has begun stepping up action against businesses that treat patients with their own stem cells. Last month, it issued a warning letter to Celltex Therapeutics Corp., the largest facilitator of the therapy in the Houston area, saying the process it puts the cells through alters them and makes them a biologic drug. The letter said the therapy was thus under FDA jurisdiction.

Perry's position

The letter was delivered just a few months after the Texas Medical Board began implementing a policy allowing doctors to use stem cells banked at facilities such as Celltex as long as it's part of research overseen by a panel that reviews clinical trials for patient safety. The TMB said it was allowing stem-cell use because it couldn't wait on the FDA.

As a result of the FDA letter, Celltex is in the process of closing down its 2012 trials.

Perry told the media after his keynote address that he disagrees with the FDA's decision on Celltex. He said that therapy involving one's own stem cells should no more be regulated by the FDA than bone marrow transplants or in-vitro fertilization.

Stem cells are cells in the body that multiply to replenish dying cells. The basis of what's known as regenerative medicine because of their ability to grow new tissue and repair diseased or injured body parts, they are touted by some as the future of medicine.

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Perry brings his stem-cell cause to Houston

Stem cell therapy a cure-all? Not so fast

By Stem Cell Treatment

MANILA, Philippines Its supposed to cure various illnesses such as cancer, spinal cord injury and Parkinsons disease. Is stem cell therapy the cure-all that it is touted to be?

Health Undersecretary Teodoro Herbosa said it is important to note that stem cell treatments are still at the experimental stage.

"The advisory is very clear. This is still an investigative form of therapy. Anecdotal reports are not enough evidence to say there is treatment, he said in an interview on ANC's Talkback with Tina Palma.

He said there are only two standard stem cell therapies considered effective and acceptable to the medical community.

"To date, I can only name two cases that are considered standard therapy. That is bone marrow transplantation--one for severe cancer, blood cancer and the other one is bone marrow transplantation after chemotherapy for any type of cancer, he said.

Herbosa said the Department of Health cannot confirm yet if stem cell treatment is indeed effective against certain diseases.

Dr. Tranquilino Elicao Jr., an oncologist who availed of the treatment in April in Frankfurt, Germany, said stem cell therapy cured his high blood pressure, sugar, cholesterol and uric acid.

He had 12 injections of cells, which came from lambs.

After a month, I had my blood tests. Everything went down to normal, Elicao said.

Elicao also said he is not taking medication anymore because he has regained his health.

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Stem cell therapy a cure-all? Not so fast

Journal Stem Cell Translational Medicine to Publish Article on FDA Communications and the Regulatory Pathway for Cell …

By Uncategorized

WASHINGTON, DC--(Marketwire - Oct 17, 2012) - The Alliance for Regenerative Medicine (ARM), the international organization representing the interests of the regenerative medicine community, announced the publication today of an article on FDA communications to help companies developing cell-based therapies by clarifying the development pathway. The article, entitled "Communications with the FDA on the Development Pathway for a Cell-Based Therapy: Why, What, When, and How?" will be published in the journal Stem Cells Translational Medicine. It is co-authored by representatives from ARM, Janssen R&D, GE Healthcare and Life Technologies, with the lead author from the California Institute for Regenerative Medicine (CIRM).

"There are a number of ways cell-based therapy companies can communicate with FDA that will help them navigate the road from the bench to a regulatory submission," said Michael Werner, Executive Director of ARM. "We hope that our combined experience as co-authors, and our attempt to create a single source of guidance on the regulatory process, will help companies bring new cell-based therapies through clinical trials and the regulatory review process more quickly so they can reach patients faster," added Mr. Werner.

Lead author Ellen Feigal, MD, Senior Vice President for Research and Development at the California Institute for Regenerative Medicine (CIRM) commented, "Cell-based therapies represent a fundamentally new way to treat or cure disease, but developing a new therapy is costly, time consuming and fraught with uncertainty. Our paper takes a practical approach to clarifying the path to market."

"Communications with the FDA on the Development Pathway for a Cell-Based Therapy: Why, What, When, and How?" provides detailed information on options for communicating with the FDA at different stages; the official communications tied to each stage of development; and the most common reasons regulatory applications are delayed. The article can be accessed at: http://stemcellstm.alphamedpress.org/content/early/recent

About CIRM: CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities. A list of grants and loans awarded to date may be seen here: http://www.cirm.ca.gov/for-researchers/researchfunding.

About ARM: The Alliance for Regenerative Medicine is a Washington, DC-based multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, DC to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today ARM has more than 120 members and is the leading global advocacy organization in this field. In March 2012, ARM launched a sister organization in Europe -- the Alliance for Advanced Therapies. For more information go to http://www.alliancerm.org.

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Journal Stem Cell Translational Medicine to Publish Article on FDA Communications and the Regulatory Pathway for Cell ...

NeoStem, Inc. Announces the Redemption of the Outstanding 7% Series E Preferred Stock

By Uncategorized

NEW YORK, Oct. 17, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), an emerging leader in the fast growing cell therapy market, today announced that it will redeem all outstanding shares of its Series E 7% Senior Convertible Preferred Stock ("Series E Preferred Stock").

On October 10, 2012, the Company gave notice to its Series E Preferred Stockholders that it is redeeming all of the outstanding shares of Series E Preferred Stock for an aggregate redemption price of $3.4 million, $2.5 million of which was funded by money placed into escrow when the Series E Preferred stock was issued in November 2010.

"We are pleased that we have been able to redeem this $10 million investment in full over a two year period. Equal to our focus on cell therapy product development and expanding our PCT contract development and manufacturing operations, we are committed to improving our balance sheet. Through the redemption of the Series E Preferred Stock, we will remove a significant overhang and simplify NeoStem's capital structure. The redemption of the Series E Preferred Stock is another example of a step taken by us to improve Common Stockholder value," said Dr. Robin Smith, Chairman and CEO of NeoStem. "We look forward to continued execution on our near term business strategy, including the forthcoming closing of the divestiture of our Erye China pharmaceutical subsidiary."

About NeoStem, Inc.

NeoStem, Inc. continues to develop and build on its core capabilities in cell therapy, capitalizing on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. We are emerging as a technology and market leading company in this fast developing cell therapy market. Our multi-faceted business strategy combines a state-of-the-art contract development and manufacturing subsidiary, Progenitor Cell Therapy, LLC ("PCT"), with a medically important cell therapy product development program, enabling near and long-term revenue growth opportunities. We believe this expertise and existing research capabilities and collaborations will enable us to achieve our mission of becoming a premier cell therapy company.

Our contract development and manufacturing service business supports the development of proprietary cell therapy products. NeoStem's most clinically advanced therapeutic, AMR-001, is being developed at Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011. Amorcyte is developing a cell therapy for the treatment of cardiovascular disease and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is collaborating with Becton-Dickinson in the early clinical exploration of a T-cell therapy for autoimmune conditions. In addition, pre-clinical assets include our VSELTM Technology platform as well as our mesenchymal stem cell product candidate for regenerative medicine. Our service business and pipeline of proprietary cell therapy products work in concert, giving us a competitive advantage that we believe is unique to the biotechnology and pharmaceutical industries. Supported by an experienced scientific and business management team and a substantial intellectual property estate, we believe we are well positioned to succeed.

For more information on NeoStem, please visit http://www.neostem.com.

Forward-Looking Statements for NeoStem, Inc.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, including with respect to the Company's or its partners' successful development of AMR-001 and other cell therapeutics, the size of the market for such products, its competitive position in such markets, the Company's ability to successfully penetrate such markets and the market for its contract development and manufacturing ("CDMO") business, and the efficacy of protection from its patent portfolio, as well as the future of the cell therapeutics industry in general, including the rate at which such industry may grow. Forward looking statements also include statements with respect to satisfying all conditions to closing the disposition of Erye, including receipt of all necessary regulatory approvals in the PRC. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors, including but not limited to matters described under the "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 20, 2012 and in the Company's other periodic filings with the Securities and Exchange Commission, all of which are available on its website. The Company does not undertake to update its forward-looking statements. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.

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NeoStem, Inc. Announces the Redemption of the Outstanding 7% Series E Preferred Stock

FDA issues warning letter to local stem cell company

By Stem Cell Treatment

The Food and Drug Administration has informed the Sugar Land company involved in Gov. Rick Perry's adult stem-cell procedure that it is illegally marketing an unlicensed drug.

In a warning letter, the FDA gave Celltex Therapeutics Corp. 15 business days to submit a plan to address the agency's concerns, including correcting previously cited manufacturing problems. The letter said that failure to respond promptly could result in seizure or injunction by the FDA.

"Based on (our) information, your product violates the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act," says the letter, sent on Sept. 24 and publicly posted Tuesday.

The letter comes about six months after the FDA made a 10-day inspection of the facilities where Celltex banks and grows stem cells taken from prospective patients. The agency subsequently filed a report, obtained by the Chronicle in June, detailing dozens of manufacturing deficiencies, from incorrectly labeled products to failed sterility tests.

The new warning letter reiterates those problems and asks for more information about them.

David Eller, Celltex's CEO, was unavailable Tuesday, but a public relations official said the company on Wednesday would make available a redacted copy of its letter to the FDA.

In a previous news release, Eller said Celltex "respectfully but firmly" disagreed with the FDA's position that its process causes the cells to be considered biological drugs and thus subject to the federal agency's regulations. Biological drugs involve living human cells, as opposed to chemically synthesized drugs.

"We are considering all options as we work with the agency toward a resolution," Eller said in the release.

Adult stem cells multiply to replenish dying cells. Long used to treat leukemia and other cancers, they have recently shown promise for tissue repair in other diseases, though most scientists in the field consider them not ready for mainstream use.

Treatment, at a price

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FDA issues warning letter to local stem cell company

FDA issues warning to local stem cell company

By Stem Cell Treatment

The Food and Drug Administration has informed the Sugar Land company involved in Gov. Rick Perry's adult stem-cell procedure that it is illegally marketing an unlicensed drug.

In a warning letter, the FDA gave Celltex Therapeutics Corp. 15 business days to submit a plan to address the agency's concerns, including correcting previously cited manufacturing problems. The letter said that failure to respond promptly could result in seizure or injunction by the FDA.

"Based on (our) information, your product violates the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act," says the letter, sent on Sept. 24 and publicly posted Tuesday.

The letter comes about six months after the FDA made a 10-day inspection of the facilities where Celltex banks and grows stem cells taken from prospective patients. The agency subsequently filed a report, obtained by the Chronicle in June, detailing dozens of manufacturing deficiencies, from incorrectly labeled products to failed sterility tests.

The new warning letter reiterates those problems and asks for more information about them.

David Eller, Celltex's CEO, was unavailable Tuesday, but a public relations official said the company on Wednesday would make available a redacted copy of its letter to the FDA.

In a previous news release, Eller said Celltex "respectfully but firmly" disagreed with the FDA's position that its process causes the cells to be considered biological drugs and thus subject to the federal agency's regulations. Biological drugs involve living human cells, as opposed to chemically synthesized drugs.

"We are considering all options as we work with the agency toward a resolution," Eller said in the release.

Adult stem cells multiply to replenish dying cells. Long used to treat leukemia and other cancers, they have recently shown promise for tissue repair in other diseases, though most scientists in the field consider them not ready for mainstream use.

Treatment, at a price

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FDA issues warning to local stem cell company

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