NeoStem's Stem Cell Therapy Fails Mid-Stage Heart Attack Study

By: Adam Feuerstein | 11/18/14 - 10:16 AM EST

Inject a cocktail of undifferentiated stem cellsinto a patient who has suffered a heart attack, and days or even weekslater, the stem cells transform into cardiac cells and rebuild the damaged heart muscle. Months later, the patient has a "new" healthy heart.It's a great story. But so far, the proof remains elusive though not for a lack of trying.

The latest company to fulfill this ambitious scenario is NeoStem (NBS) which presented disappointing (but not surprising) results from a small study of its proprietary cardiac stem-cell therapy NBS10 at the American Heart Association annual meeting Monday. NeoStem tried to put some positive spin on the bad news but shares are down 25% to $5.10.

NBS10, formerly known as AMR-001, is an autologous stem-cell therapy derived from a patient's own bone marrow. When injected back into patients following a heart attack, the stem cells are supposed torestore blood flow, rebuild damaged cardiac muscle and improve function.

Except in NeoStem's study, NBS10 fell short on two primary endpoints designed to assess the therapy's efficacy. The study used non-invasive imaging to assess blood flow through the heart, six months after a single infusion of NBS10 or a placebo. There was no difference between NBS and placebo, NeoStem said.

The study's other co-primary efficacy endpoint was a measurement of adverse cardiac "MACE" events --defined as cardiovascular death, a repeatheart attack, heart failure hospitalization and coronary revascularization. To date, 17% of patientstreated with NBS10 have suffered a MACE event compared to 19% of patients in the placebo arm -- a difference which was not statistically significant.

NeoStem said NBS10 therapy was safe relative to placebo and that no patients treated with the stem cells have died compared to three deaths in the placebo patients. But with only one year of follow up on a small number of patients, any claims about a mortality benefit are clinically meaningless.

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NeoStem's Stem Cell Therapy Fails Mid-Stage Heart Attack Study

Cardiac stem cell therapy may heal heart damage caused by Duchenne muscular dystrophy

PUBLIC RELEASE DATE:

17-Nov-2014

Contact: Sally Stewart sally.stewart@cshs.org 310-248-6566 Cedars-Sinai Medical Center @cedarssinai

LOS ANGELES (NOV. 17, 2014) - Researchers at the Cedars-Sinai Heart Institute have found that injections of cardiac stem cells might help reverse heart damage caused by Duchenne muscular dystrophy, potentially resulting in a longer life expectancy for patients with the chronic muscle-wasting disease.

The study results were presented today at a Breaking Basic Science presentation during the American Heart Association Scientific Sessions in Chicago. After laboratory mice with Duchenne muscular dystrophy were infused with cardiac stem cells, the mice showed steady, marked improvement in heart function and increased exercise capacity.

Duchenne muscular dystrophy, which affects 1 in 3,600 boys, is a neuromuscular disease caused by a shortage of a protein called dystrophin, leading to progressive muscle weakness. Most Duchenne patients lose their ability to walk by age 12. Average life expectancy is about 25. The cause of death often is heart failure because the dystrophin deficiency leads to cardiomyopathy, a weakness of the heart muscle that makes the heart less able to pump blood and maintain a regular rhythm.

"Most research into treatments for Duchenne muscular dystrophy patients has focused on the skeletal muscle aspects of the disease, but more often than not, the cause of death has been the heart failure that affects Duchenne patients," said Eduardo Marbn, MD, PhD, director of the Cedars-Sinai Heart Institute and study leader. "Currently, there is no treatment to address the loss of functional heart muscle in these patients."

During the past five years, the Cedars-Sinai Heart Institute has become a world leader in studying the use of stem cells to regenerate heart muscle in patients who have had heart attacks. In 2009, Marbn and his team completed the world's first procedure in which a patient's own heart tissue was used to grow specialized heart stem cells. The specialized cells were then injected back into the patient's heart in an effort to repair and regrow healthy muscle in a heart that had been injured by a heart attack. Results, published in The Lancet in 2012, showed that one year after receiving the experimental stem cell treatment, heart attack patients demonstrated a significant reduction in the size of the scar left on the heart muscle.

Earlier this year, Heart Institute researchers began a new study, called ALLSTAR, in which heart attack patients are being infused with allogeneic stem cells, which are derived from donor-quality hearts.

Recently, the Heart Institute opened the nation's first Regenerative Medicine Clinic, designed to match heart and vascular disease patients with appropriate stem cell clinical trials being conducted at Cedars-Sinai and other institutions.

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Cardiac stem cell therapy may heal heart damage caused by Duchenne muscular dystrophy

UCLA Stem Cell Researcher Pioneers Gene Therapy Cure for Children with "Bubble Baby" Disease

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Newswise UCLA stem cell researchers have pioneered a stem cell gene therapy cure for children born with adenosine deaminase (ADA)-deficient severe combined immunodeficiency (SCID), often called Bubble Baby disease, a life-threatening condition that if left untreated can be fatal within the first year of life.

The groundbreaking treatment was developed by renowned stem cell researcher and UCLA Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research member Dr. Donald Kohn, whose breakthrough was developed over three decades of research to create a gene therapy that safely restores immune systems in children with ADA-deficient SCID using the patients own cells with no side effects.

To date, 18 children with SCID have been cured of the disease after receiving the stem cell gene therapy in clinical trials at UCLA and the National Institutes of Health.

All of the children with SCID that I have treated in these stem cell clinical trials would have died in a year or less without this gene therapy, instead they are all thriving with fully functioning immune systems said Kohn, a professor of pediatrics and of microbiology, immunology and molecular genetics in Life Sciences.

To protect children born with SCID they are kept in isolation, in controlled environments because without an immune system they are extremely vulnerable to illness and infection that could be lethal.

Other current options for treating ADA-deficient SCID are not always optimal or feasible for many children, said Kohn. We can now, for the first time, offer these children and their families a cure, and the chance to live a full healthy life.

Defeating ADA-Deficient SCID: A Game-Changing Approach

Children born with SCID, an inherited immunodeficiency, are generally diagnosed at about six months. They are extremely vulnerable to infectious diseases, and in a child with ADA-deficient SCID even the common cold can prove fatal. The disease causes cells to not create an enzyme called ADA, which is critical for production of the healthy white blood cells that drive a normal, fully-functioning immune system. About 15 percent of all SCID patients are ADA-deficient.

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UCLA Stem Cell Researcher Pioneers Gene Therapy Cure for Children with "Bubble Baby" Disease

Pope warns against the false sense of compassion in euthanasia

Vatican City

Pope Francis has warned doctors and ethicists on several hot-button social issues, attacking abortion, embryonic stem cell research and euthanasia as playing with life and a sin against God.

In a strongly worded address that marked a departure for a pope who tends to focus more on social justice issues, Francisdenounced what he called the false sense of compassion that was used to promote abortion and those who regarded euthanasia as an act of dignity.

We are living in a time of experimentation with life. But a bad experiment, the pope told members of the Association of Italian Catholic Doctors at the Vatican Saturday.

Francisalso condemned in vitro fertilization, which he said promoted children as a right rather than a gift to welcome, and embryonic stem cell research, which used human beings as guinea pigs to presumably save others.

This is playing with life, he said. Be careful, because this is a sin against the Creator: against God the Creator, who created things this way.

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Francis has spoken out several times against the assisted suicide movement, which he considers to be a symptom of todays throw-away culture that views the sick and elderly as a drain on society.

On Saturday, the pope said it was unlawful to take a life and warned of the dangers posed to the elderly by hidden euthanasia in our culture of waste.

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Rodrigo Alves who has spent 125k on plastic surgery splashes out ANOTHER 5k

Rodrigo Alves, 30, has undergone 20 cosmetic procedures Those include nose jobs, liposuction, six-pack and pec implants Underwent stem cell hair surgery to cover balding patches on head 5,100 procedure saw doctors perform liposuction in his back to extract fat Mixed this with 500ml of his blood and extracted the stem cells The mixture was then injected into his scalp and he loves the results

By Bianca London for MailOnline

Published: 11:14 EST, 17 November 2014 | Updated: 12:20 EST, 17 November 2014

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An air steward who has spent 125,000 on plastic surgery in a bid to turn himself into a real-life Ken doll has become the first person in the UK to have stem cell hair treatment.

Rodrigo Alves, 30, has undergone 20 cosmetic procedures including nose jobs, liposuction, six-pack and pec implants, calf shaping and botox fillers.

But that, it seems, is not enough for Mr Alves who recently had his 21st cosmetic treatment - a pioneering form of stem cell surgery that claims to fix baldness.

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Rodrigo Alves who has spent 125k on plastic surgery splashes out ANOTHER 5k

Beyond Batten Disease Foundation and the New York Stem Cell Foundation Chosen as a National Innovator by the Milken …

New York, New York (PRWEB) November 17, 2014

Beyond Batten Disease Foundation (BBDF) and the New York Stem Cell Foundation (NYSCF) have been selected as a national innovator by the Milken Institute and will present their breakthrough findings about juvenile Batten disease at the 6th annual Partnering for Cures, November 16-18 in New York City. The presentation will highlight the collaborative efforts of NYSCF, BBDF and Batten Disease Support and Research Association.

Craig and Charlotte Benson established Beyond Batten Disease Foundation in August 2008 after their then five-year-old daughter, Christiane, was diagnosed with juvenile Batten disease. Together with hundreds of families affected by Batten disease, and many more supporters who share their hope and resolve, they are working tirelessly to create a brighter future for Christiane, and all children with Batten disease.

Watch the Benson Family story:

The Benson Family Story

Beyond Batten Disease and the New York Stem Cell Foundation hope to ramp up funding and partnerships to develop stem cell resources to investigate and explore new treatments and ultimately find a cure for juvenile Batten disease, a fatal illness-affecting children as they convene at the FasterCures, conference. The Washington, D.C.-based center of the Milken Institute will bring together nearly 1,000 medical research leaders, investors and decision-makers to forge the collaborations needed to speed and improve outcomes-driven R&D. NYSCF scientists have created the first iPS cells from a neurological disease and the first ever stem cell disease model from any disease. This discovery was named Time Magazine #1 breakthrough in 2008 because it was the first time anyone has made stem cells from a person with a disease and used them to produce the type of cell that degenerated in that patient. Again, in 2012 Time Magazine recognized the Beyond Batten Disease Foundations creation of a rate genetic disease test as a top ten medical breakthrough.

We know the genetic mutations associated with juvenile Batten disease. This partnership will result in stem cell models of juvenile Batten, giving researchers an unprecedented look at how the disease develops, speeding research towards a cure, said Susan L. Solomon, NYSCF Chief Executive Officer.

Working with NYSCF to generate functional neuronal subtypes from patients and families is a stellar example of one of our key strategies in the fight against juvenile Batten disease: creating resource technology with the potential to transform juvenile Batten disease research and accelerate our timeline to a cure, said Danielle M. Kerkovich, PhD, BBDF Principal Scientist.

Juvenile Batten disease begins in early childhood between the ages of five and ten. Initial symptoms typically begin with progressive vision loss, followed by personality changes, behavioral problems, and slowed learning. These symptoms are followed by a progressive loss of motor functions, eventually resulting in wheelchair use and premature death. Seizures and psychiatric symptoms can develop at any point in the disease.

Juvenile Batten disease is one disorder in a group of rare, fatal, inherited disorders known as Batten disease. Over 40 different errors (mutations) in the CLN3 segment of DNA (gene) have been attributed to juvenile Batten disease. The pathological hallmark of juvenile Batten is a buildup of lipopigment in the bodys tissues. It is not known why lipopigment accumulates or why brain and eventually, heart cells are selectively damaged. It is, however, clear that we need disease-specific tools that reflect human disease in order to figure this out and to build therapy.

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Donor: The German teenager who saved my life: How a global network of stem cell donors found an unlikely saviour for a …

Sue Walters only chance of survival from leukaemiawas a stem cell transplant No one in her family matched her tissue type Doctors searched the worldwide donor register They found Nicola Gerber, a student from Mechern, near the French border

By Chloe Lambert for the Daily Mail

Published: 20:21 EST, 17 November 2014 | Updated: 20:35 EST, 17 November 2014

When Sue Walters was diagnosed with leukaemia, she hoped that the best of medical science would be used to cure it.

What she could never have anticipated was that her life would be saved by an 18-year-old boy from a remote German village.

Sues only chance of survival was a stem cell transplant previously known as a bone marrow transplant.

What Nicola has done is amazing it really is a gift of life. If I hadnt had the transplant, it was unlikely Id have lived beyond three months,' said Sue Walters of her donor Nicola Gerber

This would give her a new, stronger immune system to destroy the cancerous cells in her blood.

No one in her family matched her tissue type, so doctors searched the worldwide donor register and found Nicola Gerber, a student from Mechern, near the French border.

He had recently registered as a stem cell donor, and was the perfect match.

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Donor: The German teenager who saved my life: How a global network of stem cell donors found an unlikely saviour for a ...

Veteran Actor Darius McCrary from Family Matters Receives Stem Cell Procedures with Dr. Raj in Beverly Hills

Beverly Hills, California (PRWEB) November 17, 2014

Veteran television and movie actor Darius McCrary has received a revolutionary stem cell procedure for his painful knee and ankle. The regenerative medicine procedure with stem cells was performed by Dr. Raj, a top orthopedic doctor in Beverly Hills and Los Angeles.

Darius McCrary is well known for his decade long stint on Family Matters as character Eddie Winslow. He won a Best Young Actor Award for this role along with movie roles in both Mississippi Burning and Big Shots. Currently, Darius appears along with Charlie Sheen in the show Anger Management.

While staying in tip top shape for his career, Darius has developed persistent pain in his right knee and ankle. Rather than seek a regular cortisone injection for pain relief or opt for surgery, he desired the ability to repair the joint damage and achieve pain relief. "I couldn't imagine being immobilized because of injury, so I opted for a stem cell procedure."

The procedures were performed by Dr. Raj, who is a prominent Beverly Hills orthopedic doctor with extensive experience in regenerative medicine. The procedure consisted of a combination of platelet rich plasma therapy along with amniotic derived stem cell therapy. Anecdotal studies are showing that the stem cell procedures for extremity joints allow patients to achieve pain relief and often avoid the need for potentially risky surgery.

Dr. Raj has performed over 100 stem cell procedures for patients who have degenerative arthritis or sports injuries. "Patients do extremely well with the procedures. Minimal risk and there's a huge potential upside!"

With an active acting career, Darius McCrary cannot afford to be distracted with chronic pain. "I'm looking forward to getting back in the gym and going hard without this pain," he stated excitedly. The procedure was filmed and can be seen on Dr. Raj's Facebook page.

To discuss stem cell procedures at Beverly Hills Orthopedic Institute and how they can benefit, call (310) 247-0466.

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Veteran Actor Darius McCrary from Family Matters Receives Stem Cell Procedures with Dr. Raj in Beverly Hills

UW professor using stem cell research to find treatment for eye conditions

Through stem cell research, two Madison men who suffer from a genetic condition that causes blindness and hearing loss are receiving experimental treatment.

Johnny and Mike Walsh, sons of University of Wisconsin Regent David Walsh who suffer from Usher disease are receiving experimental treatmentfrom David Gamm, a UW professor and expert in retinal and stem biology.

Johnny has had hearing problems from birth and is now legally blind. However, he maintains a positive attitude due to the experimental treatment he is receiving in Madison and does not let his disability get in the way of his career as an attorney at Axley Brynelson LLP.

It is interesting that here I am in Madison getting a diagnosis and then having such a great research institution there in my backyard and its convenient for them to have my family there because you got four kids, three who carry the genes, two who are affected and one who isnt. So you have a perfect control right there, I think thats kind of neat for Dr. [David] Gamm to have and he takes our blood whenever he needs it, Walsh said.

Mike started a project entitled Flight4Sight, where he travels the world to spread awareness and understanding about blindness. His project is on Facebook and a blog, where he takes his followers advice on where to travel next.

Mike said he benefits from the research Gamm, of the Waisman Center,does.

Gammis working closely with Cellular Dynamics International, a Madison-based company which has recently received a $1.2 million grant to continue their research on human stem cells.

CDI specializes in creating human cells, including various types of stem cells. With the National Eye Institutes funding, CDI will carry out this stem cell-based research in the first study of its kind to be performed in the United States.

Eye conditions that include dry age-related macular degeneration affect as many as 11 million Americans who have some form of macular degeneration, according to the CDI statementregarding the grant. The cells being used for this study are CDI developed and manufactured through induced pluripotent stem cells, which will potentially have application in discovering treatments for retinal and eye conditions.

The goal of the study will be to find out how to reprogram stem cells in order to make retina cells to prevent further damage in decaying eyes and eye conditions, Gamm said.

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UW professor using stem cell research to find treatment for eye conditions

Stem Cells Treatment Not Useful In Stroke Patients Finds Indian Study

A large-scale trial conducted in India has shown that stem cell therapy does not work in stroke patientsREUTERS

A study conducted on 120 patients in India has shown that stem cell treatment is not effective in treating paralysis resulting from a stroke.

The research which is thefirst large-scale study conducted in Indiacompared outcomes in those treated with stem cells to others and found no difference, reports Down to Earth.

While 60 patients with some form of disability of limbs caused by a stroke were given conventional treatment, an equal number received bone marrow stem cells in addition. All had experienced a stroke 3-4 weeks before the trial.

"We found that at the end of the first month, patients with stem cells showed more improvement compared to the control group. But at the end of the third month and one year, there was no difference," said Kameshwar Prasad, head, Department of Neurology, All India Institute of Medical Sciences (AIIMS), who led the study.

On an average 280 million bone marrow cells were injected, of which blood forming stem cells were around 2.9 million per patient.

The average age of patients in the study was around 50.

The study, published in the current issue of American journal Stroke, was conducted at AIIMS in New Delhi and four other hospitals covering four cities.

The study comes when many others have been suggesting that stem cells could help treat paralysis in stroke patients. The earlier study was done on a small number of patients as compared to the AIIMs study.

More research needs to be done, before stem cells are used in therapy as in India, many private clinics are openly offering stem cell treatment for various diseases.

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Stem Cells Treatment Not Useful In Stroke Patients Finds Indian Study