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NeoStem Announces Proposed Public Offering of Common Stock and Warrants

NEW YORK, March 28, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE Amex:NBS) ("NeoStem" or "the Company"), a leader in the cell therapy industry, today announced that it intends to offer and sell shares of its common stock and warrants in an underwritten public offering. All of the shares and warrants in the offering will be sold by NeoStem. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. The securities will be issued pursuant to a prospectus supplement filed as part of an effective registration statement on Form S-3 previously filed with the Securities and Exchange Commission (SEC).

Maxim Group LLC is acting as book-runner of the offering.

A shelf registration statement relating to the securities was filed with the SEC, which became effective on June 13, 2011. A preliminary prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC's website at http://www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, from Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174 or via telephone at (212) 895-3685.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. NeoStem intends to file a preliminary prospectus supplement relating to the offering with the SEC, which will be available along with the prospectus filed with the SEC in connection with the shelf registration, on the SEC's website at http://www.sec.gov.

About NeoStem, Inc.

NeoStem, Inc. ("we," "NeoStem" or the "Company") continues to develop and build on its core capabilities in cell therapy to capitalize on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a large role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. Our January 2011 acquisition of Progenitor Cell Therapy, LLC ("PCT") provides NeoStem with a foundation in both manufacturing and regulatory affairs expertise. We believe this expertise, coupled with our existing research capabilities and collaborations, will allow us to achieve our mission of becoming a premier cell therapy company. Our PCT subsidiary's manufacturing base is one of the few current Good Manufacturing Practices ("cGMP") facilities available for contracting in the burgeoning cell therapy industry. Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011, is developing a cell therapy for the treatment of cardiovascular disease. Amorcyte's lead compound, AMR-001, represents NeoStem's most clinically advanced therapeutic and has commenced enrollment for a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. We also expect to begin a Phase 1 clinical trial by 2013 to investigate AMR-001's utility in arresting the progression of congestive heart failure and the associated comorbidities of that disease. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is engaged in collaboration with Becton-Dickinson that is exploring the earlier stage clinical development of a T-cell therapy for autoimmune conditions. In addition, our pre-clinical assets include our VSELTM Technology platform as well as our MSC (mesenchymal stem cells) product candidate for regenerative medicine.

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

Forward-Looking Statements

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 and medical strategy, including with respect to the development of AMR-001 and other cell therapies and its divestiture of its interest in Suzhou Erye Pharmaceutical Co., Ltd. about which no assurance can be given. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the "Risk Factors" described in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 19, 2012 and in the Company's periodic filings with the Securities and Exchange Commission. 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 Announces Proposed Public Offering of Common Stock and Warrants

NeoStem Announces Pricing of Public Offering for $6,000,000 in Gross Proceeds

NEW YORK, March 29, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE Amex:NBS) ("NeoStem" or "the Company"), a leader in the cell therapy industry, announced today the pricing of an underwritten public offering of 15,000,000 units at $0.40 per unit. Each unit consists of one share of common stock and a warrant to purchase one share of common stock with a per share exercise price of $0.51. Maxim Group LLC acted as sole bookrunner. The Company expects to receive $6,000,000 in gross proceeds, prior to deducting underwriting discounts and commissions and offering expenses payable by the Company. These funds will be used for working capital purposes, including research and development of cell therapeutic product candidates, expansion of business units, strategic transactions and other general corporate purposes. The Company has granted the underwriters a 45-day option to purchase up to an additional 2,250,000 units to cover over-allotments.

The financing is expected to close on or about April 3, 2012, subject to the satisfaction of customary closing conditions.

This offering is being made by means of a prospectus supplement and accompanying prospectus. Copies of the final prospectus supplement and accompanying prospectus relating to this offering may be obtained from the Securities and Exchange Commission's website at http://www.sec.gov or from Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174 or via telephone at (212) 895-3685.

A shelf registration statement relating to the offering was previously filed with the Securities and Exchange Commission and became effective on June 13, 2011. This press release is neither an offer to sell nor a solicitation of an offer to buy any of the Company's securities. No offer, solicitation or sale will be made in any jurisdiction in which such offer, solicitation or sale is unlawful.

Further information regarding the offering is contained in the Company's Current Report on Form 8-K to be filed with the Securities and Exchange Commission and which may be accessed at http://www.sec.gov.

About NeoStem, Inc.

NeoStem, Inc. ("we," "NeoStem" or the "Company") continues to develop and build on its core capabilities in cell therapy to capitalize on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a large role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. Our January 2011 acquisition of Progenitor Cell Therapy, LLC ("PCT") provides NeoStem with a foundation in both manufacturing and regulatory affairs expertise. We believe this expertise, coupled with our existing research capabilities and collaborations, will allow us to achieve our mission of becoming a premier cell therapy company. Our PCT subsidiary's manufacturing base is one of the few current Good Manufacturing Practices ("cGMP") facilities available for contracting in the burgeoning cell therapy industry. Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011, is developing a cell therapy for the treatment of cardiovascular disease. Amorcyte's lead compound, AMR-001, represents NeoStem's most clinically advanced therapeutic and has commenced enrollment for a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. We also expect to begin a Phase 1 clinical trial by 2013 to investigate AMR-001's utility in arresting the progression of congestive heart failure and the associated comorbidities of that disease. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is engaged in collaboration with Becton-Dickinson that is exploring the earlier stage clinical development of a T-cell therapy for autoimmune conditions. In addition, our pre-clinical assets include our VSELTM Technology platform as well as our MSC (mesenchymal stem cells) product candidate for regenerative medicine.

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

Forward-Looking Statements

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 and medical strategy, including with respect to the development of AMR-001 and other cell therapies and its divestiture of its interest in Suzhou Erye Pharmaceutical Co., Ltd. about which no assurance can be given. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the "Risk Factors" described in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 19, 2012 and in the Company's periodic filings with the Securities and Exchange Commission. 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 Announces Pricing of Public Offering for $6,000,000 in Gross Proceeds

Stem cell therapy for 13-year-old dog helps with its arthritis

COLUMBIA, SC (WIS) - A few weeks ago, we told you the story of Maggie, the 13-year-old Boykin Spaniel who was suffering from arthritis.

Maggie is enjoying life once again thanks to a new type of surgery. The dog received stem cell therapy surgery six weeks ago.

Doctors were able to use adult stem cells from Maggie's blood and fat samples to collect repair cells. They then took the cells and repaired the dog's arthritic spine.

Maggie's owner, Beth Phibbs, says she could tell the dog had been in pain.

"You could tell she didn't feel well, but yet now she is like she's 5 and she's 13. She just runs out and she plays. I think she knows. She can feel the difference," Phibbs said.

The surgery costs about $2,000, but Medi-vet America says this costs about half as much as the older treatments.

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Stem cell therapy for 13-year-old dog helps with its arthritis

New Data Show BioCision’s CoolCell Family of Products Outperform Traditional Cryopreservation Methods

MILL VALLEY, Calif.--(BUSINESS WIRE)--

BioCision LLC today released new data demonstrating that the companys CoolCell technology resulted in a 33 percent increase in human embryonic stem cell (hESC) viability when compared to common freezing methods, such as styrofoam boxes, paper towel wraps and alcohol-based methods.

Based on thermo-conductive principles and developed through precision-engineering, CoolCell is a rate-controlled cryopreservation system that ensures uniform and reproducible freezing rates for biological samples, including primary cells, cell lines, stem cells, yeast and other cell types.

Addressing the lack of standardization in common sample handling, processing and viable long-term storage has emerged as one of the greatest challenges facing biobanks, diagnostics companies and researchers today, said Rolf Ehrhardt, CEO, BioCision. Scientists know that error is inherent in sample handling and can be the difference between viable and non-viable cells, particularly when handling embryonic stem cells that are extremely fragile following thawing.1

Researchers set out to compare cell recovery rates post-thaw using the CoolCell method of cryopreservation and three commonly used methods with two human Embryonic Stem Cell (hESC) lines, RC-7 and RC-10. The study concluded that:

The study was conducted in collaboration with scientists at Edinburgh-based Roslin Cellab, a stem cell technology company with expertise in the stem cell culture and regenerative medicine field, and sister company to Roslin Cells, a leading European and UK provider of clinical grade human embryonic stem cells.

The results of our study show that the CoolCell technology clearly outperforms all other methods and provides excellent efficiency and reproducibility for stem cell cryopreservation and recovery, said Aidan Courtney, Director at Roslin Cellab.

About CoolCell

CoolCell alcohol-free cell cryopreservation systems provide highly reproducible controlled-rate freezing for eukaryotic cells, including primary cells, cell lines, stem cells, PBMC, yeast and other types of cells. Used worldwide in academic, research and clinical laboratories, CoolCell is the standard for passive controlled-rate cell cryopreservation. The CoolCell technology - using novel thermo-conductive alloy and highly insulative materials - ensures precise heat removal from each tube and standardizes the freezing experience of all cryogenic tubes in a -80C freezer.

Benefits include:

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New Data Show BioCision’s CoolCell Family of Products Outperform Traditional Cryopreservation Methods

Antibody Shrinks Tumors Of Seven Cancers

Featured Article Academic Journal Main Category: Cancer / Oncology Also Included In: Immune System / Vaccines;Stem Cell Research Article Date: 28 Mar 2012 - 2:00 PDT

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Senior author Dr Irving Weissman, professor of pathology at Stanford, and colleagues, write about their success in treating bladder, brain, breast, colon, liver, ovarian, and prostate cancer tumors in this week's online ahead of print issue of the Proceedings of the National Academy of Sciences.

They say the antibody blocks a protein known as CD47, that sends "don't eat me" signals that cancer cells use to stop macrophages and other cells of the immune system from gobbling them up.

Anti-CD47 is the first antibody treatment to work against a variety of human solid tumors. The investigators said they are now eager to get started with phase 1 and phase 2 clinical trials in humans within the next two years.

The treatment also significantly reduced the ability of the tumors to spread (metastasize) to other parts of the mice's bodies, and in some cases, the animals appeared to be "cured".

Weissman, who directs the Institute of Stem Cell Biology and Regenerative Medicine and the Ludwig Center for Cancer Stem Cell Research and Medicine, both at Stanford, told the press their findings show "conclusively" that CD47 is a "a legitimate and promising target for human cancer therapy":

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Antibody Shrinks Tumors Of Seven Cancers

New gene therapy approach developed for red blood cell disorders

ScienceDaily (Mar. 27, 2012) A team of researchers led by scientists at Weill Cornell Medical College has designed what appears to be a powerful gene therapy strategy that can treat both beta-thalassemia disease and sickle cell anemia. They have also developed a test to predict patient response before treatment.

This study's findings, published in PLoS ONE, represents a new approach to treating these related, and serious, red blood cells disorders, say the investigators.

"This gene therapy technique has the potential to cure many patients, especially if we prescreen them to predict their response using just a few of their cells in a test tube," says the study's lead investigator, Dr. Stefano Rivella, Ph.D., an associate professor of genetic medicine at Weill Cornell Medical College. He led a team of 17 researchers in three countries.

Dr. Rivella says this is the first time investigators have been able to correlate the outcome of transferring a healthy beta-globin gene into diseased cells with increased production of normal hemoglobin -- which has long been a barrier to effective treatment of these disease.

So far, only one patient in France has been treated with gene therapy for beta thalassemia, and Dr. Rivella and his colleagues believe the new treatment they developed will be a significant improvement. No known patient has received gene therapy yet to treat sickle cell anemia.

A Fresh Approach to Gene Therapy

Beta-thalassemia is an inherited disease caused by defects in the beta-globin gene. This gene produces an essential part of the hemoglobin protein, which, in the form of red blood cells, carries life-sustaining oxygen throughout the body.

The new gene transfer technique developed by Dr. Rivella and his colleagues ensures that the beta-globin gene that is delivered will be active, and that it will also provide more curative beta-globin protein. "Since the defect in thalassemia is lack of production of beta-globin protein in red blood cells, this is very important," Dr. Rivella says.

The researchers achieved this advance by hooking an "ankyrin insulator" to the beta-globin gene that is carried by a lentivirus vector. During the gene transfer, this vector would be inserted into bone marrow stem cells taken from patients, and then delivered back via a bone marrow transplant. The stem cells would then produce healthy beta-globin protein and hemoglobin.

This ankyrin insulator achieves two goals. First, it protects delivery of the normal beta-globin gene. "In many gene therapy applications, a curative gene is introduced into the cells of patients in an indiscriminate fashion," Dr. Rivella explains. "The gene lands randomly in the genome of the patient, but where it lands is very important because not all regions of the genome are the same." For example, some therapeutic genes may land in an area of the genome that is normally silenced -- meaning the genes in this area are not expressed. "The role of ankyrin insulator is to create an active area in the genome where the new gene can work efficiently no matter where it lands," Dr. Rivella says. He adds that the small insulator used in his vector should eliminate the kind of side effects seen in the French patient treated with beta-thalassemia gene therapy.

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New gene therapy approach developed for red blood cell disorders

Stem cell study aids quest for motor neuron disease therapies

ScienceDaily (Mar. 26, 2012) A breakthrough using cutting-edge stem cell research could speed up the discovery of new treatments for motor neuron disease (MND).

The international research team has created motor neurons using skin cells from a patient with an inherited form of MND.

Role of protein

Using patient stem cells to model MND in a dish offers untold possibilities for how we study the cause of this terrible disease as well as accelerating drug discovery by providing a cost-effective way to test many thousands of potential treatments said Professor Siddharthan Chandran, Director of the University's Euan MacDonald Centre for MND Research.

The study discovered that abnormalities of a protein called TDP-43, implicated in more than 90 per cent of cases of MND, resulted in the death of motor neuron cells.

This is the first time that scientists have been able to see the direct effect of abnormal TDP-43 on human motor neurons.

The study, led by the University of Edinburgh's Euan MacDonald Centre for Motor Neuron Disease Research, was carried out in partnership with King's College London, Columbia University, New York and the University of San Francisco.

Motor neuron disease

MND is a devastating, untreatable and ultimately fatal condition that results from progressive loss of the motor nerves -- motor neurons -- that control movement, speech and breathing.

The study, funded by the MND Association, is published in the journal Proceedings of the National Academy of Sciences.

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Stem cell study aids quest for motor neuron disease therapies

Cell Therapy Improves Damaged Heart In Study

March 27, 2012

According to a new study, using a patients own bone marrow may help repair damaged areas of the heart caused by heart failure.

Researchers found that left ventricular ejection fraction increased by 2.7 percent in patients who received stem cell therapy.

The study, which was presented at the American College of Cardiologys 61st Annual Scientific Session, revealed that the improvement in ejection fraction correlated with the number of CD34+ and CD133+ cells in the bone marrow.

This is the kind of information we need in order to move forward with the clinical use of stem cell therapy, Emerson Perin, MD, PhD, director of clinical research for cardiovascular medicine at the Texas Heart Institute and the studys lead investigator, said at the event.

The study included 92 patients who were randomly selected to receive stem cell treatment or placebo. The patients all had chronic ischemic heart disease and an ejection fraction of less than 45 percent along with heart failure.

Doctors placed a catheter in the hearts left ventricle to inject 3 ccs, or 100 million stem cells, into an average of 15 sites of the stem cell patients hearts.

The doctors used electromechanical mapping of the heart to measure the voltage in areas of the heart muscle and create a real-time image of the heart.

With this mapping procedure, we have a roadmap to the heart muscle, said Dr. Perin. Were very careful about where we inject the cells; electromechanical mapping allows us to target the cell injections to viable areas of the heart.

The trial was designed to determine whether left ventricular end systolic volume and myocardial oxygen consumption improved in patients who received stem cell treatment.

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Cell Therapy Improves Damaged Heart In Study

Cancer research targets a key cell protein

Blocking "don't destroy me" signals that normally sit on the surface of tumor cells and render them resistant to immune-cell attack slows the growth of a broad range of human cancers when they're implanted in mice, researchers have found.

The approach, reported by immunologists at the Stanford University School of Medicine, was effective against ovarian, breast, colon, bladder, liver, prostate and brain cancer cells. If the work can be repeated in people, the approach may someday help doctors marshal defender cells in patients' own bodies to fight cancers, the researchers said.

Key to the work is a cell protein called CD47, which is already being investigated in the treatment of leukemia.

CD47 sits on cell membranes and communicates with various immune cells, including macrophages, which gobble up foreign invaders in the body. It plays an important role in the normal life cycle of healthy red blood cells, telling macrophages to leave the cells alone.

In the study, the scientists injected the animals with antibodies that bind to CD47 and block out its protective signal.

"If we can block this signal, we can get the immune system to eat [the cancer cells] up," said Stephen Willingham, a postdoctoral researcher in the laboratory of immunologist Dr. Irving Weissman at Stanford and first author of a paper about the work.

The Stanford team examined cancer cells removed from patients with a variety of types of solid tumors. They found that CD47 studded the membranes of almost all of the cancer cells in their sample, suggesting that it is a molecule common to all cancers.

Placing the cells in lab dishes, the team administered an antibody: a protein that binds to CD47 and blocks it from warding off immune system cells. Macrophages ate the cells.

The researchers then implanted human tumor cells in mice for further study. They allowed the cancers to grow, and administered the antibody against CD47.

Antibody treatment inhibited the growth of almost all of the solid tumors and was able to wipe out some smaller cancers altogether, according to the report, which was published Monday in the journal Proceedings of the National Academy of Sciences.

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Cancer research targets a key cell protein

Bone marrow stem cells improve heart function, study finds

Public release date: 24-Mar-2012 [ | E-mail | Share ]

Contact: Traci Klein newsbureau@mayo.edu 507-284-5005 Mayo Clinic

CHICAGO -- A research network led by a Mayo Clinic physician found that stem cells derived from heart failure patients' own bone marrow and injected into their hearts improved the function of the left ventricle, the heart's pumping chamber. Researchers also found that certain types of the stem cells were associated with the largest improvement and warrant further study.

The results were presented today at the 2012 American College of Cardiology Meeting in Chicago. They will also be published online in the Journal of the American Medical Association.

This Phase II clinical trial, designed to test this strategy to improve cardiac function, is an extension of earlier efforts in Brazil in which a smaller number of patients received fewer stem cells. For this new network study, 92 patients received a placebo or 100 million stem cells derived from the bone marrow in their hips in a one-time injection. This was the first study in humans to deliver that many bone marrow stem cells.

"We found that the bone marrow cells did not have a significant impact on the original end points that we chose, which involved reversibility of a lack of blood supply to the heart, the volume of the left ventricle of the heart at the end of a contraction, and maximal oxygen consumption derived through a treadmill test," says Robert Simari, M.D., a cardiologist at Mayo Clinic in Rochester, Minn. He is chairman of the Cardiovascular Cell Therapy Research Network (CCTRN), the network of five academic centers and associated satellite sites that conducted the study. The CCTRN is supported by the National Heart, Lung, and Blood Institute, which also funded the study.

"But interestingly, we did find that the very simple measure of ejection fraction was improved in the group that received the cells compared to the placebo group by 2.7 percent," Dr. Simari says. Ejection fraction is the percentage of blood pumped out of the left ventricle during each contraction.

Study principal investigators Emerson Perin, M.D., Ph.D., and James Willerson, M.D., of the Texas Heart Institute, explain that even though 2.7 percent does not seem like a large number, it is statistically significant and means an improvement in heart function for chronic heart failure patients who have no other options.

"This was a pretty sick population," Dr. Perin says. "They had already had heart attacks, undergone bypass surgery, and had stents placed. However, they weren't at the level of needing a heart transplant yet. In some patients, particularly those who were younger or whose bone marrows were enriched in certain stem cell populations, had even greater improvements in their ejection fractions."

The average age of study participants was 63. The researchers found that patients younger than 62 improved more. Their ejection fraction improved by 4.7 percent. The researchers looked at the makeup of these patients' stem cells from a supply stored at a biorepository established by the CCTRN. They found these patients had more CD34+ and CD133+ type of stem cells in their mixture.

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Bone marrow stem cells improve heart function, study finds