Stem Cell Therapy to Repair Damaged Knee Cartilage

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Rush University Medical Center is conducting the nation’s first clinical study of an innovative stem cell drug, Cartistem, to repair knee cartilage damaged by aging, trauma or degenerative diseases such as osteoarthritis.

Cartistem is manufactured from mesenchymal stem cells derived from allogeneic (donor) umbilical cord blood. Umbilical cord blood is a readily accessible source of high-quality stem cells, is associated with minimal health risks and carries relatively few ethical concerns.

The stem cells are mixed with hyaluronan, a natural polymer that plays a major role in wound healing and is a building block of joint cartilage. Cartistem is surgically administered into the area of cartilage damage following an arthroscopic surgery as an adjunct to microfracture, a commonly used technique used to repair cartilage damage.

The principal investigator on the study is Dr. Brian Cole, a professor in the department of orthopedics and anatomy and cell biology at Rush University Medical Center. Dr. Cole is the head of Rush’s Cartilage Restoration Center and is also the head team physician for the Chicago Bulls. Cole and his co-researchers will assess the drug’s safety as well as its ability to regenerate cartilage repair tissue and reduce pain in patients with localized cartilage loss in the knee.

Treating cartilage damage can be problematic because the tissue does not contain blood vessels or nerves and therefore has a limited ability to re-grow. Various treatments for cartilage degeneration, such as drug therapy, arthroscopy and joint replacement, yield mixed results and are unable to regenerate damaged tissue.

“Finding a biological solution for cartilage regeneration in orthopedics is one of the fastest growing areas of research and development in our specialty, said Cole. “Rush is spearheading this field of research with the ultimate goal of safely improving outcomes and sparing patients from having more complicated surgery at a relatively young age.”

The two-year, phase I/IIa study will enroll a total of 12 participants aged 18 years and older, with a body mass index of less than 35. Initially, six individuals with lesions sized 2 to 5 centimeters will be recruited into the study; an additional six volunteers with lesions larger than 5 centimeters will be enrolled sequentially. Each participant will undergo eligibility screening followed by a 12-month observation period to determine the safety and efficacy of the drug with an additional long-term follow-up evaluation at 24 months.

“With a burgeoning aging, yet active population, our patients are looking for effective non-joint replacement solutions to treat their damaged knee cartilage,” said Cole. “This research is significant in that it utilizes a commonly performed operation (microfracture) in an effort to improve upon variable outcomes.”

“Notably, this is a treatment for patients with localized cartilage damage and not for patients who are diagnosed with diffuse or bone on bone arthritis who have otherwise been told they require a knee replacement.” said Cole.

Source: Sciencedaily.com

Avoid the Knife (and Drugs) With Alternative Therapy

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by Linda Larrowe Bergersen

Six years ago my husband had stem cells injected into his heart (injured during a routine medical procedure) to strengthen it and to possibly avert any future deterioration; this was performed in Bangkok, by physicians trained and associated with U.S. stem cell professionals. He was the 35th patient to ever receive stem cells derived from his own blood through this newly-patented procedure. Today, with stem cells and nutritional therapy, he is more vibrant than ever. The procedure had strengthened his heart muscle by 50 percent. Back then, stem cell therapy was considered a Star Wars concept, and still is in many minds, but today this alternative therapy seems to be snowballing into becoming mainstream.

It’s unfortunate that the majority of Americans still equate all stem cell therapy with embryos, but what’s not as prominently known is that there are adult stem cells, which includes those derived from bone marrow, personal blood, fat cells, and donated cells of brain and skin tissue.

Today there are reported and verified cases of remarkable reversal of debilitating physical ailments such as stroke, pain, bone and ligament injuries by the injection of stem cells. It’s unfortunate that Americans are still pressed to travel overseas for most stem cell treatments for the heart, but there are centers throughout the U.S. that offer options for various conditions that stem cells can benefit. A person does not have to be fearful of this any longer. The stigmas that were once attached to these precarious alternatives are now disappearing. The stigma of stem cells per se as only coming from embryos is slowly eradicating with the growing awareness that stem cells can be extracted from other sources.

John Brodie, once a dynamic NFL football quarterback, experienced a significant stroke in 2000 that left him debilitated, bedridden, without control of his bodily functions. Now, after stem cell therapy in Europe, he is walking, talking and now has a better quality of life. I personally know a woman who had been in a horrific automobile accident many, many years ago that left her legs in constant pain, recently had injections of her own stem cells derived from her own fat. Within days, her pain was gone, and walking was no longer agonizing; for the last year there has been no pain since the two treatments. Also, Peyton Manning, another notable quarterback, has reportedly undergone stem cell injections in Europe, using his own fat cells, for his recent neck injury.

Yes, stem cell therapy is costly, and like all breakthrough procedures, in time the price will go down. But stem cell therapy is just one of many alternative therapies that anyone can be offered to relieve myriad conditions; here are just a few:

  • Stem cell therapy
  • EECP therapy
  • Hyperbaric chamber therapy
  • Glutathione/chelation therapy
  • Medical marijuana

Enhanced external counterpulsation (EECP) is a little-known therapy that actually is Harvard-produced, FDA-approved, and Medicare-approved (for certain medical problems). This is a non-invasive procedure of electrodes applied to the chest, and attached to an electrocardiograph machine to monitor heart rhythm, while cuffs are wrapped around the ankles, thighs and buttocks to gently compress the blood vessels in the lower limbs, increasing blood flow to the heart. The completed therapy aids in restoring circulation to a functional level. Success stories include relief from angina, obstructed circulation, and congestive heart failure, yet the average patient is rarely told about this option. In fact, it does not become an option with doctors because for them there is no major financial benefit, it is a hindrance to their office structure, and not conducive with their cardiological acumen, says Dr. Richard N. Fogoros, former professor of medicine at the University of Pittsburgh. And because of this, it is hard to find a center to go to. A series of 35 sessions is the standard allowable therapy that has been determined to achieve the optimum benefit. This is a treatment that more and more people should request in order to bring it to light. As the FDA and Medicare have approved this procedure, it makes sense to give it a try.

Hyperbaric oxygen therapy may be the most efficient method of transporting oxygen to every cell of the body. And oxygen is what the body needs for recuperation from trauma. Hyperbaric therapy for stroke and brain injury have not had enough trials and studies to determine their degrees of efficacy, but personal successes have been continually reported over the years, since the public became aware of this after President Kennedy authorized it for his ailing baby. Successes and continual use have proven that it does warrant an option for anyone in dire need of improvement after such trauma. It is FDA- and Medicare-approved for such things as severe wound healing, carbon monoxide poisoning, smoke inhalation, and diabetic foot ulcers. In knowing this, it shows that it is deemed safe, and does have merit. And for anyone wishing to try oxygen therapy for improvement after a stroke, there are centers throughout the country that offer this, where they strongly believe in beneficial results. The necessary amount of sessions is usually at least 20 to see signs of improvement.

Glutathione and chelation therapies are nutritional, natural approaches to improving health and health conditions. Glutathione is considered ”the mother of all antioxidants.” We all have a natural stream of glutathione running through our system, and major trauma and disease will lower this supply. When our supply is low, our bodies suffer, and have difficulty in any recuperation process. This nutrient can get a boost by taking certain other supplements such as R-lipoic acid, milk thistle and N-acetyl cysteine, but through intravenous therapy (IV) this remarkable nutrient can be presented directly, in its purest form. IV glutathione is offered at nutritional centers all over the country. David Perlmutter, M.D., neurologist, has done research with this antioxidant and Parkinson’s, and has found it to be “quite effective” in improving symptoms. It has had great resultsin treating fibromyalgia, chronic fatigue syndrome, Alzheimer’s, autoimmune diseases, liver and brain detoxification, and autism. A study in 2010 involving the Cleveland Clinic has shown marked improvement in treating male infertility.

Chelation is another natural approach to improving health. This IV procedure introduces EDTA into the body, a synthetic amino acid first introduced in the 1940s that draws out heavy metals and free radicals from the body naturally. It is a proven treatment for lead poisoning in hospitals. Doctors throughout the country offer chelation for detoxification purposes, and purport that it may also have the ability to dissolve plaque and calcium blockages. Larger studies are needed to show proof to the medical community, FDA and Medicare, that it can be a preventive measure inheart disease before approving it. Lead poisoning is something much more prevalent and harmful to children than adults. The symptoms can include:

• Abdominal pain and cramping
• Aggressive behavior
• Anemia
• Constipation
• Sleep disturbance
• Headaches
• Irritability
• Loss of previous developmental skills (in young children)
• Low appetite and energy
• Reduced sensations

Lead and other heavy metals accumulated in the body can cause health maladies at any age, like joint pain, circulation problems and autoimmune diseases. Length of treatment relates to each particular ailment.

Medical marijuana of course is a controversial treatment, legal in just 16 states at the present. But studies have shown its effectiveness in helping with chronic pain, especially in cancer patients, as well as helping with chemotherapy-induced nausea and vomiting. It has helped many with sleep disorders; those with major debilitating diseases, such as multiple sclerosis or HIV, use it to cope with side effects. For end-stage disease, medical marijuana could be considered for bettering the quality of remaining life.

There are suggestions that the beneficial substance in marijuana, THC, should be made into a drug instead of allowing the patient to smoke marijuana in its original form. Because it cannot be patented since it’s not a drug, the FDA has yet to approve it. Several independent companies are currently in the process of producing pill-form marijuana by extracting certain compounds such as cannabidiol that seems to be effective on pain and inflammation but does not give the high effect.

“Marijuana contains anti-inflammatory, antioxidant, and probably anticancer compounds in it,” says Dr. Donald Abrams, an oncology physician and professor of clinical medicine at the University of California, San Francisco (UCSF). “I’m a cancer doctor and I often suggest to my patients that they consider marijuana for their loss of appetite, nausea, pain, depression, and insomnia. That’s one medicine they can use instead of five.”

Too many times patients are not given the options of the preventive treatments that can save them from forthcoming surgeries, unnecessary harmful prescription drugs, and debilitating pain. With the onset of the increased awareness concerning alternative therapies, everyone now has more options to improve their health and well-being. Personal physicians should be queried about these options, but if they do not have the knowledge or do not approve, then, as patients, second opinions are warranted. We are in control of our health, and can and should be proactive. Without physician referral, it is imperative that we take upon ourselves the initiative to research and explore these and any natural therapeutic options.

Source: huffington post.

Adult Stem Cells: A Piece of My Heart, From Cells in My Arm

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I left my heart in Minnesota — a tiny, pulsing piece of it, anyway.

The folks at the Mayo Clinic call it “Lil’ Bill” and it lives in a comfortable Petri dish on a climate-controlled shelf deep in the bowels of the renowned hospital.

Each day it is taken out for care and feeding and very smart people carefully check to make sure it is growing bigger and stronger by the hour.

Chances are remote that Lil’ Bill will ever join its genetic brethren in my chest, but the fact that I can peer through a microscope and see my own cardiac tissue pulse at 60 beats a minute proves that we are tantalizingly close to a Holy Grail of healing: regenerative medicine.

Because though Lil’ Bill acts like heart muscle, it didn’t come from my heart. It came from the skin under my arm.

Doctors have dreamed of a day when science could grow healthy spare parts in a lab for the human body. A pivotal moment in this search came in the late ’90s when the first embryonic stem cells were isolated. These cells are the biological “seeds” that divide, differentiate and grow into the myriad parts of the human body.

While it was a thrilling discovery, it was also the start of an ethical and political firestorm, since an embryo had to be destroyed in order to isolate its stem cells. In 2001, President George W. Bush signed an executive order to restrict further research.

The move forced scientists to search for other ways and in 2007, researchers in Japan and Wisconsin figured out a way to reprogram adult cells into stem cells. Word of the discovery reached Mayo, and Dr. Tim Nelson and his colleagues at the Center for Regenerative Medicine were intrigued. This could be a way to help all those kids, born with deformed hearts, who sit on transplant waiting lists at Mayo each year.

“This is one technology that allows us to understand disease,” Dr. Nelson told me, “but it also allows us to dream about the day we apply that therapeutically.” And as he described his work, he made me a tantalizing offer. If I would agree to partake in their research, he said I “could be the first person to ever see his own heart tissue beat outside his body.”

It began with a biopsy of the skin under my left bicep, all the better to hide the tiny scar. With a small round knife, Dr. Nelson dug out a pencil eraser-sized chunk of my flesh and plopped it into a jar of pink liquid. I flew home and they went to work, using a combination of genes to bioengineer these bits of flesh into pluripotent (“many potentials”) stem cells. At that stage, they could’ve nudged them into becoming neurons or lung cells or even parts of my eyeball, but in keeping with Dr. Nelson’s promise, the Mayo team turned them into cardiac tissue.

Months later, I returned for a one-of-a-kind reunion and gazing through that microscope, I could see pumping proof why this kind of medical science just won the Nobel Prize.

Dr. Nelson got most excited when he showed me a tiny piece of my cardiac tissue that had dramatically formed into the shape of a heart — a pumping, three-dimensional glimpse into a future when this kind of cell could theoretically be injected into a heart-attack victim or a diseased child and literally mend the person from within.

That is the hope, but while these cells could grow hearts, lungs or brains they could also grow tumors. So it could be years before the science is ready for first clinical trials on humans.

For parents of kids on the transplant list, the work cannot go fast enough.

Source: ABC News
By BILL WEIR (@BillWeirABC)

‘Brimming with energy’ after $20K stem cell treatment

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Visit NBCNews.com for breaking news, world news, and news about the economy

Jennifer Vasilakos got the shocking surprise of her life after helping a man who stopped to ask her for directions. That man happened to be the billionaire founder of the Beanie Baby company and what he did may have saved her life. NBC’s Kristen Dahlgren reports.

By Kristen Dahlgren and Erica Ayisi, NBC News

What started out as a modest fundraising event held in a Santa Barbara, Calif., parking lot has turned into a life-changing moment for Jennifer Vasilakos, thanks to a chance meeting with Beanie Baby billionaire Ty Warner.

It all began in a parking lot in July of last year. Vasilakos, 42, set up a table near her hometown’s annual Santa Barbara French Festival to raise money for stem cell treatment, displaying signs and flyers that explained her cause. She also brought a small moneybox to stash cash made from parking cars for festival-goers.

Equipped with sunglasses, a water bottle and coffee, Vasilakos was prepared to spend the day raising awareness and telling people her personal story – that she was diagnosed with acute renal failure in 2011 and had received dialysis three times a day, three times a week. It was a grueling regimen that she would endure the rest of her life. A kidney transplant wasn’t an option; she had been rejected as a candidate because of a previous bout with cancer.

Vasilakos, a Reiki teacher and herbalist, decided her only option was to save up for stem cell treatment – a costly procedure that is not performed in the United States.

But as the day wore on, her moneybox largely remained empty. The festival, she said, “was completely dead.”

That’s when a lost driver in a “small little car” drove up, looking for directions. Jennifer chatted him up.

Louis Lanzano / ASSOCIATED PRESS

Ty Warner, Beanie Baby creator and chief executive of Ty Inc., arrives at the Toy Fair to sign

“The man rolls down the window, has a piece of paper in his hand and he’s looking for a local business,” she recalled. “I provide him instructions and because I am fundraising that day to get my stem cell treatment, I hand him my flyer.”

The man gave her $50.

About an hour later, the driver returned, looked her in the eye and asked if she was the woman in the flyer raising money for stem cell treatment. She confirmed that she was.

Courtesy of Jennifer Vasilakos

Jennifer Vasilakos received this note from Ty Warner, accompanied by a check for $20,000. It reads: “Dear Jennifer, Someone up there loves you because I was guided to meet you on Saturday. I never lose my way, but fate had me lost and ask you for direction. The rest of the story I hope will be a wonderful new life for you. God bless you Jennifer. Ty.”

The man replied, “I’m Ty Warner, and I’d like to help you with this and take care of it for you.”

Yes, that Ty Warner – of Ty Inc., the billionaire brain behind the Beanie Babies collectibles craze. Vasilakos said she recognized his name but had no idea he would ultimately make a huge donation.

“I was hoping to raise a few hundred dollars that day by the generosity of my community for the stem cell treatment that I needed to get,” she said. “I had no idea I would meet Ty Warner that day.”

On her blog, Vasilakos wrote: “I listened as he repeated over and over that he was going to help me. That my fundraising was done.  That I didn’t need to worry any longer. He said he would send a check after he returned to his offices during the week.”

Several days after they met, Vasilakos received a $20,000 check from Warner along with a handwritten note. She said she hopes it “was a little birdy in his ear that said, ‘You should help this woman.’”

Vasilakos had the stem cell treatment last year in Trinidad.

Warner, according to a prepared statement, was enlightened by their chance encounter.

“After I serendipitously met Jennifer, I further educated myself on her stem cell needs. I was shocked that this particular type of treatment wasn’t available to her in the U.S.,” Warner said. “My hope is that we can bring this lifesaving treatment to the forefront so that it can become more readily available and provide alternatives for people like Jennifer.”

Vasilakos underwent the treatment in September 2012 and now, after months of recovery, she says she feels great.

“The day the length of my dialysis treatment was reduced to two and half hours per treatment was an exciting day. I regained three hours of freedom per month! My blood pressure has dropped down to normal with lower and lower levels of medication,” she wrote recently on her blog. “The biggest change is how amazing I feel, and I am brimming with energy. My immune system has become resilient, and I can feel the difference in my body.”

 

2012 Breakthroughs In Cell Therapy Development

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The last year has been transcendent for cell therapy, with countless medical breakthroughs in the space. During the last year, we have made strides to learn more about its many benefits, and now the possibility of an approved cell therapy does not seem unrealistic. Therefore, in this article I am looking at the best of the best, those developments that could have industry changing effects, and could open new doors in the immediate future. Specifically, I am looking at the leader in cell therapy,NeoStem (NBS), a company that had a truly breakthrough year.

Quick Highlights from 2012

Cell therapy has always been a segment of intrigue, but mostly for its regenerative capabilities in the sports medicine field. Up until recently, cell therapy was considered by many to be junk science, quackery, and a focus that could not hold up under the regulatory requirements of the FDA. However, in recent history, cell therapy has shown that it can be a cure for sexual dysfunction; an answer for cerebral palsy; return motor function for those with paralysis; return sight to the blind; and even stop the spread of cancer.

The developments above were those that took place in 2012; as a record$1 billion was brought and raised to continue the development of cell therapy products during the last year. In 2012 alone, the first U.S. manufactured cell therapy was approved for use - the U.S. made strides in deciding to regulate marketing claims – public companies advanced into late stage clinical studies – we saw two newly approved cell therapy products in the Korean market – a Nobel prize was awarded for research in cell therapy – and finally, a favorable debate on the regulation of adult stem cells as a drug. With such an incredible year, 2013 might be setting itself up to be even better than last year.

First Approval of a U.S. Manufactured Cell Therapy!

Cell therapy company, Osiris Therapeutics (OSIR) achieved in obtaining the first approval with a cell therapy as the main component in its product, Prochymal. The therapy is now approved in both New Zealand and in Canada for children with graft-vs-host disease. This is a major accomplishment because it sets the stage for other cell therapy approvals in the future. The stock has since bolstered to a market cap of $300 million, showing a substantial amount of excitement for this company and its drug. And although the therapy will not have a large market outcome in terms of sales (the company’s market is most likely less than 100 people per year), the approval itself is still exciting for the industry.

While developments surrounding regulatory approvals, spinal cord injuries, and Alzheimer’s disease have remained top catalysts for the excitement surrounding the space, NeoStem continues to be the best measure of success in the industry. I have chosen to invest in NeoStem because of its diverse presence in the cell therapy arena. And in 2012, the company made several breakthroughs in the industry, some of which remained under-the-radar. I would like to more fully investigate this leader in cell therapy, and two accomplishments that may pay great dividends in the next few years.

Finding a Threshold of CD34+ Cell Dose

NeoStem’s lead candidate is a Phase 2 cell therapy product, AMR-001, that has often been compared to Baxter’s (BAX) successful Phase 3 CD34+ cell therapy product. Unlike Baxter’s CD34+ cell therapy, NeoStem uses a cell combination of CD34+CXCR4+ for a natural repair mechanism to repair the heart muscles following an acute myocardial infarction. There are approximately 800,000 myocardial infarction events that occur every year in the U.S., and although there is a strong clinical belief that CD34+ cells could be most effective at treating a multitude of conditions, a threshold dose has remained a mystery; that is until NeoStem’s findings in 2012.

In a high-profile series of studies that measured the efficacy of autologous bone marrow mononuclear cells in acute myocardial infarction, three clinical studies supported by the U.S. Federal Government and coordinated by Cardiovascular Cell Therapy Research Network (CCTRN) found some very interesting results. The studies were considered a failure, but the reasons for the failure are now coming to light thanks to NeoStem. Among these studies was “TIME”, which found that only 2.2% of participants corresponded to 3.3 million CD34+ cells. Keep in mind that these particular cells have been considered the workhorse of regeneration, but this study made many believe otherwise. In fact, it was this study that helped push shares of NeoStem lower, as many believed that it was a good indication that the company’s billion-dollar product would be unsuccessful.

NeoStem’s breakthrough was in its Phase 2 product, AMR-001, which uses CD34+CXCR4+ cells. The company found that, when using 10 million cells, no patients experienced a deterioration of heart muscle function. However, 30-40% of patients did experience deterioration when receiving less than 10 million cells. What does this mean? It means that NeoStem found the ever-so-important therapeutic dose to this workhorse of regeneration, and that the TIME study was most likely unsuccessful because it was not using a therapeutic dose (not even close to a therapeutic dose). This is a significant breakthrough because the use of CD34+ cells is crucial to the development of cell therapy products for the treatment of cardiovascular disorders; and NeoStem now has the leg up.

Creating a New Method of Treatment

NeoStem’s very small embryonic-like stem cells (VSELs) could be the most promising game changer in cell therapy (possibly all of medicine); that is if it works and if it’s developed correctly. Up until recently, it had just been an idea, one that avoids the potential political and moral dilemmas that come with using many of the best cell therapy products. The reason is because it doesn’t use human embryos, but rather bone marrow-derived cells that mimic and are structurally similar to that of highly effective embryo cells.

Before going any further, I want to share an example of the dilemmas surrounding not just embryonic cells, but others. This has been a heavily debated area of development for cell therapy companies, such asNeuralStem (CUR). NeuralStem is developing an investigational cell product, NSI-566RSC, for the treatment of Lou Gherig’s disease (ALS). And in a Phase 1 trial of 12 patients, with 100,000 cells per injection, the company made a true medical breakthrough as patients responded extraordinarily well to the therapy.

Neuralstem was heralded for its informative study and the results that followed by the prominent stem cells assays. We learned a great deal about the product and its efficiency as all patients tolerated the therapy well. Furthermore, these same cells were used in a study of paralyzed rats-and these rats regained a remarkable level of motor function after being treated with the stem cells.

The one problem for Neuralstem might be that its source of cell material is the spinal cord of single eight-week fetus, and for whatever reason, the company has chosen to conduct its Phase 2 trial in Mexico (and its other trial in China). The company is apparently testing U.S. patients in Mexico and the FDA has been somewhat slow to advance the trial, and has made the design difficult for Neuralstem. So despite the company having a truly transcendent and potentially life-altering therapy, we must wonder if these decisions could indicate that the FDA will not approve the therapy, regardless. More than likely, it has something to do with moral dilemmas, a problem that many cell therapy products face. The problem for cell therapy companies is and also remains developing a cell therapy product that is as effective as the more controversial cell materials while avoiding the moral and political backlash that could prevent a great therapy from earning an FDA approval.

There has been one common belief in cell therapy, which is changing the process of development: Despite the fact that embryonic stem cells (and other controversial cells) can differentiate into nearly all cell types, no therapy using these cells will ever become marketable due to ethical concerns from certain religious and political organizations. Dr. Jalees Rehman, a physician and a cell biologist, discusses this issue in-depth in his article, “The Importance of Being Embryonic”.

Dr. Rehman discusses the evolution of cells and the perfect balance found with induced pluripotent stem cells, which are cells not created from embryos, but are converted into an “embryonic state”. This belief, and the study behind these findings, won Shinya Yamanaka the Nobel prize in 2012, whose work abolishes the need for human embryonic cells. In comparison, the embryonic and the converted cells are near identical, thus could perform the same function without the moral drama. As a result, it is clear to see how any news regarding NeoStem’s VSELs would be heralded as a potential great opportunity.

Due to the upside combined with the benefits, VSELs is a well-funded technology that is being developed to treat a variety of indications, including: bone regeneration, eye disease, wound healing, sciatic nerve regeneration, radiation exposure, etc. And recently, NeoStem found that its VSELs actually created bone from cells when implanted in the bone tissue of SCID mice. The company is now moving forward in clinical studies to further develop the technology.

Now what makes VSELs so promising, for both investors and NeoStem, are the current trends in regenerative medicine. According to a recent study by Stem Cells Assays, the NIH Center for Regenerative Medicine funded just 9% of human embryonic projects, meanwhile 30% and 47% to human non-embryonic and non-human non-embryonic cell projects. This shows that NeoStem’s discovery with VSELs could continue to be developed with the support of regulators and other institutions. As a result, if VSELs can continue to produce meaningful results, then NeoStem should have no problem in gaining regulatory support, which could open the door for an entire line of therapeutics using these cells.

Conclusion:

Despite these incredible findings, NeoStem has only returned gains of 17.50% in 2012. It’s a company that is already producing sales with its manufacturing business, some expecting revenue between $25 and $30 million in 2013. Therefore, the stock is trading at just 3.5 times 2013′s revenue; and with the two clinical developments above (AMR-001 and VSELs), it’s positioned to see a much more vital future.

NeoStem is not just creating “another drug”; its entire pipeline is unique, different, and could transcend treatments for the next decade. Its late-stage product, AMR-001, is showing all the signs of success, with a market potential of more than $1 billion annually. The VSELs Technology could usher in a line of products that have the potential to treat numerous injuries and diseases. Inevitably, VSELs could earn revenue in the multi-billions in the next decade. With that being said, NeoStem had a company-changing year; and in 2013, I expect a stock that reflects its potential as revenue continues to grow and the company builds on its clinical developments of 2012.

Source: seekingalpha

Small Cap Chinese Stem Cell Stocks to Watch

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Small cap stocks China Cord Blood Corp (CO) and EastBridge Investment Group Corp (EBIG) are active in the Chinese stem cell market while and Neostem Inc (NBS) recently exited the market to focus on the US market.

 

While stem cell research and treatment has attracted controversy in the States, small cap Chinese stem cell stocks or players in the industry likeChina Cord Blood Corp (NYSE: CO), EastBridge Investment Group Corp (PINK: EBIG) and Neostem Inc (NYSEAMEX: NBS) have no qualms about advancing scientific and medical knowledge (Note: Neostem Inc has just sold its stake in a Chinese stem cell company to focus on its US activities). Moreover and given China’s huge and aging population, the Chinese pharmaceutical market is worth $50 billion today; but within five years, its expected to become the world’s second largest health care market. That means opportunities will abound for large and small cap players alike in the Chinese stem cell market, but it should be said that investing in Chinese stocks is never for the risk adverse as even Chinese stocks have been impacted by allegations against the lower quality Chinese stocks. With that in mind, here is a quick overview at China Cord Blood Corp, EastBridge Investment Group Corp and Neostem Inc:

China Cord Blood Corp (NYSE: CO) Counts Kohlberg Kravis Roberts As an Investor

China Cord Blood Corp is a life sciences enterprise dedicated to the storage of umbilical cord blood stem cells. Specifically, China Cord Blood Corp provides umbilical cord blood storage services for parents to save cord blood stem cells on behalf of their children, in China and the Asia Pacific regions. In fact, China Cord Blood Corporation is the first cord blood banking operator to be approved by China’s Ministry of Health. Investors should be aware that back in April, it was reported that Kohlberg Kravis Roberts & Co. L.P. would invest $65 million into China Cord Blood Corp to get access to China’s fast-growing health-care services industry plus to take advantage of low valuations for high quality Chinese companies that have been battered by accusations against the not so high quality companies. The Wall Street Journal’s article about the investment also noted that Mainland China is fairly underpenetrated in terms of stored stem cells to total births with the rate standing at about 1% verses 22% for Taiwan and 15% for Hong Kong. In addition, it should be noted that for the second fiscal quarter of 2013, revenue rose 30.5% to $20.4 million while net income rose 6.2% to $3.9 million. China Cord Blood Corp is up 16% over the past year, but its also down 58.8% since early 2010 due mainly to the fallout from accusations against other Chinese stocks.

EastBridge Investment Group Corp (PINK: EBIG) Is a New Chinese Stem Sell Stock To Watch

The EastBridge Investment Group assists with IPOs, joint ventures and merchant banking for high-growth companies in Asia and in the United States. Recently, the company announced that it has entered into an agreement to merge with Cellular Biomedicine Group Inc. (CBMG) – which offers cell therapies for the treatment of cancer and degenerative diseases. Specifically, Cellular Biomedicine Group has developmental stem cell, progenitor cell and immune cell projects that are the result of collaborative research and development between scientists and doctors from the China and the US. In addition, Cellular Biomedicine Group’s flagship GMP facility consists of eight independent cell production lines that were designed, certified and are managed according to US standards. Under the agreement, which is expected to be completed this quarter, EastBridge Investment Group and Cellular Biomedicine Group will continue to operate as separate divisions with the combined entity planning to apply for a NASDAQ listing as soon as practicable under the ticker symbol “CBMG.” Its worth noting that besides having an experienced team of managers and scientists, Cellular Biomedicine Group has an intellectual property portfolio consisting of in-house developed protocols for regenerative medicine therapies and in-licensed immunotherapy patents and know-how exclusively for Greater China plus the company maintains a pipeline of clinical trials based on US protocols that includes potential treatments for knee osteoarthritis, liver cancer, skin cancer and spinal muscular atrophy. Otherwise and for the first nine months of 2012, The EastBridge Investment Group itself reported revenues of $6,053,828 versus $31,000 for the same period last year along with net income of $4,747,460 verses a net loss of $744,483 – not bad for a small cap trading on the OTC markets.

Neostem Inc (NYSEAMEX: NBS) Has Sold Its Stake in a Chinese Stem Cell Company

Finally, Neostem is worth briefly mentioning as it was active in the Chinese stem cell market from 2009 until late last year. Neostem’s Progenitor Cell Therapy company is a cell therapy contract manufacturing company with licensed, state-of-the art facilities in New Jersey and California for the contract development and manufacturing of proprietary cell therapy products. The Progenitor Cell Therapy company’s 80% owned subsidiary Athelos Corporation is collaborating with Becton, Dickinson and Co. (NYSE: BDX) in the early clinical exploration of a T-cell therapy for autoimmune conditions while Neostem’s subsidiary Amorcyte is developing a cell therapy for the treatment of cardiovascular disease and is enrolling patients in a Phase 2 trial. In addition, NeoStem has been active in China since 2009 when it acquired a controlling interest in Suzhou Erye Pharmaceuticals Ltd., or Erye, which has recently built and validated a new manufacturing facility with double the capacity for higher margin products. However, NeoStem completed the divestiture of its 51% ownership of Erye in November 2012 for $12,280,000 in cash with the deal also removes $30 million in short and long-term debt obligations from the company’s balance sheet. NeoStem will use the proceeds to invest in its cell therapy development and contract manufacturing activities in the USA.

The Bottom Line. Again, there is risk involved when it comes to investing in China and a whole new sector like stem cells, but for investors who can stomach the risks associated with both, China Cord Blood Corp and EastBridge Investment Group Corp are at least worth watching.

 

Source: smallcapnetwork

Adult Stem Cell Therapy Breakthrough Leads to Crowd Funding Campaign on Indiegogo.com for Centagen, Inc.

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Centagen, Inc. has announced a new discovery that allows for the expansion of a person’s own adult stem cells up to a million times without aging. The company believes this will greatly improve treatment for many types of chronic pain, disability and diseases. This might even be a real beginning at reversing the aging process since it supplies the body with a large number of one’s own rejuvenated stem cells to rebuild organs and tissues that have been damaged by aging, injury or disease. Even better this type of adult stem cell therapy could be available fairly soon.

Each of us has a limited supply of the kind of stem cells needed to rebuild, repair, and rejuvenate any part of our body. As we age, the supply and healing power of our stem cells diminishes. By providing a practically unlimited supply of one’s own rejuvenated stem cells, we may keep people young and healthy for well over a century. In particular, regenerating tissues and organs prepared by expanding one’s own stem cells could help with Alzheimer’s disease, diabetes, immune senescence, damaged heart tissue, arteriosclerosis, failing kidneys, failing hearing or eyesight, osteoporosis, weak muscles, and aged skin.

The technology requires no genetic engineering of the stem cells, so the procedure is much safer than the current procedures requiring genetic tampering. Only a patient’s adult stem cells are used, so there are no ethical issues common with embryonic stem cell use or side effects due to tissue rejection by your immune system.

Centagen has recently opened a crowd funding bid at http://www.indiegogo.com/centagen in concert withMaximum Life foundation, whose mission is to make “100 years old the new 50”.

A clear policy in stem cell therapy will foster innovative healthcare

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The rising cost of healthcare has been a cause of concern around the globe. The global economic crisis has seen governments such as the US and Japan attempting to minimise the cost of state-funded healthcare.

The increased prevalence of cardiovascular disorders, metabolic diseases, cancer, etc coupled with the emergence of more virulent forms of existing diseases poses a challenge for current medical therapies.

 

India is already seen as the world’s low-cost pharmacy as far as conventional therapies are concerned. And the recent economic and epidemiological changes present a lucrative opportunity for the Indian biotech industry to replicate this success in the field of innovative healthcare therapies that include biopharmaceuticals, vaccines, regenerative medicine, etc.

The Indian biotech industry registered a compounded annual growth rate (CAGR) of 20% in the past decade. While biosimilars — generic versions of biologic drugs — currently make the most significant contribution to the top-line, another promising field is regenerative medicine. This is a novel multi-disciplinary field that relies on cell therapeutics and bio-engineering techniques to enhance the functionality of organs and tissues.

Among various types of medical therapies that can be classified under regenerative medicine, stem cell therapy is, perhaps, the most well-known. Stem cell therapy began with bone marrow transplants.

Since then, the field has expanded to using adult stem cells, human embryonic stem cells and found uses in in-vitro-fertilization (IVF), biomaterial engineering, etc.

With stem cell products being rolled out in various parts of the world, the global stem cell market is poised to grow at a rate of 30% from 2010 to 2012 and projected to be around $1.2 billion by 2012 and expected to reach around $16 billion in 2017.

However, the stem cell market in India is still underdeveloped. In the next few years, the field of stem cell biology and regenerative medicine is likely to move towards translational research and eventually to clinical practice in India.

According to the GBI Research report, the stem cell market in India is estimated to touch $600 million by 2017. The Indian Council of Medical Research(ICMR), the apex body for the regulation of medical research in India and the Department of Biotechnology (DBT) have until now only approved indications for stem cell therapies in bone marrow transplantation, labelling all other procedures as experimental and it needs to be conducted only in the form of clinical trials.

However, stem cells have been used to restore vision in patients who have suffered corneal damage due to chemical injuries or burns. Therapies involving stem cells are also being offered as treatments for spinal cord injuries, heart ailments and Parkinson’s disease. Worldwide, scientists have even used stem cells to generate cartilage and insulin producing cells in the pancreas.

Stem cell technology seems to have huge health benefits and business potential; but it is essential to develop a framework to tap into this immense potential in a planned manner.

The government has drafted guidelines for stem cell R&D, but a definitive law is yet to be formulated. This has led to expensive procedural delays of 12-18 months that effectively drive investors away to destinations such as Malaysia that have a clear policy and decision within 90 days.

Hoschton veterinarian now offers stem cell therapy

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Boomer, a 7-year-old Mastiff, was the first patient at Hoschton Animal Clinic to undergo a new stem cell therapy to treat arthritis in his legs and hips using adult stem cells culled from the fat which was removed from Boomer’s shoulder.

Dr. Kevin Chapman DVM performed the procedure a few months ago on Boomer. His owner, Janice Whittington said, “He’s old, I just didn’t want to see him hurt anymore. It’s a miracle when they first start to respond.”

Until recent years, older pets suffering from arthritis had only painkillers and anti-inflammatory medications to help with pain relief.

Pill therapies are costly, can be harmful to the liver, and may offer only minor relief for our precious pets.

Now, a different kind of assistance is on the way, thanks to a procedure developed by MediVet America and participating veterinarians like Dr. Chapman. MediVet America is the leading developer of animal stem cell regenerative therapy for pets suffering from osteoarthritis, hip dysplasia, ligament and cartilage injuries and similar ailments.

“We feel pride in being able to offer such an advanced form of medicine to the residents of Georgia. It is more natural and permanent treatment for Arthritis than traditional pain medications and a less invasive procedure than joint replacement. I love that we are helping the body heal itself by supplying what it needs where it needs it most,” said Dr. Chapman.

The procedure uses adult animal stem cell technology and the body’s own regenerative healing power. No embryonic stem cells are used. MediVet’s kit and equipment enable veterinarians to remove a sample of fat from the pet, separate stem cells from the fat, then activate and inject the cells into the affected area. The entire procedure is all done in-clinic and on the same day.

Within about two months, most animals can be removed from pain and anti-inflammatory drugs. Results show animals that had been unable to climb stairs or jump, now are walking, running and playing.

STEM CELL THERAPY DOMINATES THE GLOBAL REGENERATIVE MEDICINE INDUSTRY

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High number of unmet needs associated with chronic diseases, as well as a rising ageing population will create a strong demand for innovative cures using stem cell therapy, says RNCOS. 
As per new report released by RNCOS, entitled, “Global Regenerative Medicine Market”, the globalstem cell therapy market, which had around US$ 5.2 Billion revenue in 2010, was the regenerative medicine industry’s largest segment with a 72.2% share. Further, the future landscape of the stem cell therapy market looks promising as there are innovative products in pipeline which, if commercialized effectively, will boost the industry’s revenue. Besides, a high number of unmet needs associated with chronic diseases, as well as the ageing population will create a strong demand for innovative cures using stem cell therapy.

The report, “Global Regenerative Medicine Market”, covers the regenerative medicine market landscape in developed regions, such as the US and Europe, and emerging markets like India and China. It investigates the key industry characteristics and trends that have a large impact in themarket performance. The report also summarizes the patent landscape and entails comprehensive information on the pipeline products of key companies.

The report is an outcome of extensive research and prudent analysis of the global regenerative medicine market providing a deep insight into the growth of key segments. Future forecasts for the industry in the report calculated on the basis of the sum of economic and judgmental analysis based on past drivers, challenges, and opportunities for expansion. Overall, the report is likely to provide clients with an optimum source of knowledge and statistics on regenerative medicine sector worldwide.

About RNCOS

RNCOS specializes in Industry intelligence and creative solutions for contemporary business segments. Our professionals analyze the industry and its various components, with a comprehensive study of the changing market behavior. Our accuracy and data precision proves beneficial in terms of pricing and time management that assist the intending consultants in meeting their objectives in a cost-effective and timely manner.