Neuralstem Completes Phase I ALS Stem Cell Trial

ROCKVILLE, Md., Aug. 27, 2012 /PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) announced the completion of the Phase I trial of its NSI-566 spinal cord neural stem cells for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), with the eighteenth patient treated. This patient, the third to return to the trial for an additional set of injections, is also the last in the Phase I portion of the trial as it is currently designed, which is scheduled to conclude six months after this final surgery.

(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO )

"We are delighted to have completed Phase I in this groundbreaking trial, the first approved by the FDA to test neural stem cells in patients with ALS," said Karl Johe, PhD, Chairman of Neuralstem's Board of Directors and Chief Scientific Officer.

"There have been many firsts in this trial, including the first lumbar intraspinal injections, the first cervical region intraspinal injections, and the first cohort of patients to receive both," said Jonathan D. Glass, MD, Director of the Emory ALS Center. "This has required incredible effort from the Emory medical and support team and I wish to express my thanks to all of them, as well as to acknowledge the generosity and courage of the patients and their families."

"We have found the procedure to be extremely safe," said Eva Feldman, MD, PhD, Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of Michigan Health System. "In some patients, it appears that the disease is no longer progressing, but it is too early to know if the result from that small number of patients is meaningful." Dr. Feldman is the principal investigator (PI) of the trial and an unpaid consultant to Neuralstem.

About the Trial

The Phase I trial to assess the safety of Neuralstem's NSI-566 spinal cord neural stem cells and intraspinal transplantation method in ALS patients has been underway since January 2010. The trial was designed to enroll up to 18 patients, the last of which was just treated. The first 12 patients were each transplanted in the lumbar (lower back) region of the spine, beginning with non-ambulatory and advancing to ambulatory cohorts.

The trial then advanced to transplantation in the cervical (upper back) region of the spine. The first cohort of three was treated in the cervical region only. The last cohort of threereceived injections in both the cervical and lumbar regions of the spinal cord. In an amendment to the trial design, The Food and Drug Administration (FDA) approved the return of previously treated patients to this cohort. The entire 18-patient trial concludes six months after the final surgery.

About Neuralstem

Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem is in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, and has been awarded orphan status designation by the FDA.

See the article here:
Neuralstem Completes Phase I ALS Stem Cell Trial

AMERICA STEM CELL, INC. Initiates a Phase I/II Trial of ASC-101 in Patients with Hematologic Malignancies Undergoing …

SAN ANTONIO--(BUSINESS WIRE)--

America Stem Cell, Inc. announced today the initiation of a single-center study at The University of Texas MD Anderson Cancer Center evaluating ASC-101 in dual-umbilical cord transplantation in patients with hematologic malignancies.

There is a significant unmet medical need to improve stem cell engraftment into bone marrow for patients undergoing umbilical cord transplantation, and America Stem Cell is committed to filling that need, said Dr. Linda Paradiso, Chief Development Officer at America Stem Cell. ASC-101 is a novel enzyme treatment that will potentially transform hematopoietic stem cell transplantation by accelerating patient immune system and platelet recovery, reducing opportunistic infections and other co-morbidities, and improving patient survival.

Enhancing umbilical cord stem cell engraftment into bone marrow in the dual cord transplant setting will improve clinical outcomes for patients with serious, life-threatening cancers and other disorders for which hematopoietic stem cell transplant is prescribed, said, Dr. Elizabeth Shpall, MD, Medical Director, Cell Therapy Laboratory and Director, Cord Blood Bank at M.D. Anderson Cancer Center and Principal Investigator on the ASC-101 Phase I/II clinical trial. The MD Anderson study has enrolled and dosed its first patient in this Phase I/II study designed to study the safety of ASC-101 in the hematopoietic stem cell transplant setting and gather preliminary data on potential clinical benefit.

ASC was founded with the vision to make stem cell transplants safer and more efficacious for patients undergoing cell therapy. The start of this trial using ASC-101 in cancer patients undergoing bone marrow transplantation is a major step forward in advancing the ASC clinical pipeline, said Lynnet Koh-LeMaire, Chief Executive Officer/Founder of America Stem Cell.

About America Stem Cell, Inc.

ASC is a privately held biotechnology company based in San Antonio, TX, with offices in San Diego, CA. It is focused on the development and commercialization of its novel enzyme technology platforms (ASC-101 and ASC-102) to improve the homing and engraftment of stem cells to target organs and increase their therapeutic potential for patients in need of stem cell transplantation. The initial focus of ASC is to transform clinical efficacy outcomes for hematopoietic stem cell transplantation with ASC-101. Additionally, these platforms have the potential to enhance efficacy outcomes for stem cell treatment of inflammation from chemotherapy/radiation, solid tumors, autoimmune diseases, and ischemic diseases including myocardial infarction and stroke. ASC has collaborations/partnerships with medical research institutions including The University of Texas M.D. Anderson Cancer Center, Oklahoma Medical Research Foundation, National Institutes of Health, Fred Hutchinson Cancer Center, University of California San Diego, the Sanford-Burnham Institute, Indiana University, Juvenile Diabetes Research Foundation, Spectrum Health Innovations as well as a corporate partnership with Kyowa Hakko Kirin. For additional information, please contact Lynnet Koh-LeMaire at (210) 410-6427, or view http://www.americastemcell.com.

See the rest here:
AMERICA STEM CELL, INC. Initiates a Phase I/II Trial of ASC-101 in Patients with Hematologic Malignancies Undergoing ...

Beanie Baby billionaire's stem cell gift

Beanie Babies billionaire Ty Warner has donated $19,000 to a woman with kidney failure (Jennifer Vasilakos, inset) to pay for a stem cell treatment she hopes will save her life. Source: Supplied

A WOMAN who gave driving directions to a lost traveller ended up with a $US20,000 cheque to pay for life-saving medical treatment.

Jennifer Vasilakos wrote in her blog that she was sitting at her stall by the side of the road in Santa Barbara California, trying to raise money for an operation.

Ms Vasilakos has kidney failure but does not qualify for a transplant because of the removal of a small spot of melanoma from her back last year.

She was seeking donations towards the cost of a stem cell treatment which she hoped could repair her kidneys, but which was not available in the US.

Then one day a stranger rolled up in a nondescript car.

"He was lost and needed directions, Ms Vasilakos blogged. "I often get asked by random strangers for directions. Not one to miss an opportunity, I handed him my flyer and he made a fifty dollar donation. As he drove off, I thought that was the end of our encounter."

But an hour later he came back and introduced himself as Ty Warner, the billionaire founder of the company that made the hit 1990s stuffed toys called Beanie Babies.

He said her "fundraising was done", went back to his office and sent her a cheque for $US20,000 ($19,200), to cover the operation, travel and accommodation.

Ms Vasilakos said the cheque arrived in a cream envelope with a handwritten letter she described as "genuine and heartfelt - the kind of letter you keep forever".

Read more here:
Beanie Baby billionaire's stem cell gift

The Post published Bristol hospital to carry out world stem cell first

PATIENTS are due to undergo a pioneering stem cell treatment to repair knee cartilage as a world first is trialled at a Bristol hospital.

The "bandage" which uses patients' own stem cells has been developed by a Bristol University spin-out company, Azellon Ltd, and will be implanted in their knee in a procedure at Southmead Hospital.

Professor Anthony Hollander with an appliance used to insert the pioneering stem cell 'bandage' into damaged knee cartilage; left, a close-up of how the knee operation is carried out

Patients with torn meniscal cartilage are now being recruited as part of the study.

In the initial phase ten patients will undergo the procedure.

Researchers have already established in laboratory tests that stem cells can be used to repair tears in cartilage, which is a common sports injury.

Anthony Hollander, who has led the research, was involved in the world's first windpipe transplant in 2008 and has used similar technology to create the stem cell bandage for patients with torn knee cartilage.

Patients who have been diagnosed with torn meniscal cartilage following an MRI scan will have a small operation to take the bone marrow from their hip.

The stem cells taken from the bone marrow will then be sent to the lab to grow them on the membrane, called a bio-scaffold, which forms the basis of the bandage. Two weeks later the bandage would be sent back to Southmead for an arthroscopy operation, using a small camera, to implant the bandage into the site of the injury.

Patients will be advised not to stand for a few weeks after the procedure. They will then be followed up on a regular basis for seven years.

Excerpt from:
The Post published Bristol hospital to carry out world stem cell first

Undetectable stem cell treatment could be the wave of the performance-enhancement future

It was a good week for the drug police. Lance Armstrong dropped his fight against the U.S. Anti-Doping Agency, and Oakland Athletics pitcher Bartolo Colon was banned 50 games by Major League Baseball for a positive testosterone test.

Bartolo Coln credits stem cell treatment for his return to Major League Baseball. (Getty)The enforcers should enjoy this moment while it lasts, because sports science is on the precipice of a potentially new era of performance enhancement: stem cell therapy, which could soon make testosterone injections as ancient as the typewriter and press enforcement agencies like USADA to play catch up once again.

"Sports medicine will definitely see a revolution in the next 10 to 50 years," says Allston Stubbs, associate professor of orthopedic surgery at Wake Forest Baptist Health. "We'll go from traditional scalpel surgery to biologic surgery. Now we operate with a knife, but we'll move to cells or growth factors."

This is both thrilling and daunting in the performance-enhancement realm, because stem cell therapy is potentially both an avenue to better performance and a doorway to undetectable enhancement.

Colon is an example of how both, if the science advances as some in the field of stem cell research believe it will, are inevitable.

First, a short primer: Stem cell therapy is where fat and/or bone marrow (both of which contain stem cells) are drawn from the body. The stem cells are then separated out from the extracted fluid and re-injected into an injured area (i.e. Colon's elbow) to help stimulate the re-growth of healthy tissue.

In 2010, Colon underwent stem cell therapy for his injured elbow and shoulder. He credited the procedure for saving his career. And even more recently, Peyton Manning reportedly traveled to Germany for a stem cell procedure on his injured neck. He's gone from the brink of retirement to the new starting quarterback for the Denver Broncos.

Certain stem cell treatments are allowed in the Unites States (usage of embryonic stem cells is not legal in the U.S.). But the science here in the States is far behind the rest of the world, which has been dabbling in stem cell therapy for years. For this reason, athletes tend to travel abroad. Colon, 38, was one of them.

[Related: Bartolo Colon suspended 50 games for testing positive for synthetic testosterone]

But there was a murky side to the story: Colon worked with a Florida-based doctor named Joseph R. Purita, who told the New York Times he has used Human Growth Hormone (banned by Major League Baseball) for the procedure in the past. Purita insisted to the Times he did not use HGH in Colon's procedure, which was conducted in the Dominican Republic. MLB investigators questioned Purita, but nothing came of it.

Go here to read the rest:
Undetectable stem cell treatment could be the wave of the performance-enhancement future

BIOTECH: Fate Therapeutics raises $9.2M for stem cell treatments

LA JOLLA ---- Fate Therapeutics Inc., a company developing stem-cell treatments, has raised $9.2 million in equity. The disclosure was made Tuesday ina regulatory filingwith the Securities and Exchange Commission.

Fate's technology uses chemicals calledstem-cell modulators that guide the path, or "fate" of non-embryonic stem cells as they mature. Left to themselves, stem cells grow unpredictably. So methods to increase the efficiency of "reprogramming" the cells into the desired kind are much in demand.

The company's most advanced treatment, ProHema, guides development of hematopoietic, or blood-forming stem cells. It's in clinical trials for blood cancer patients who are getting stem-cell transplants.

Fate has attracted notable executive and scientific talent. Biotech and venture capital veteran William Rastetter serves as chairman and interim CEO. Scientific founders include stem-cell pioneers Sheng Ding of the Gladstone Institute of Cardiac Disease, formerly of The Scripps Research Institute, and Rudolf Jaenischof the Whitehead Institute.

View original post here:
BIOTECH: Fate Therapeutics raises $9.2M for stem cell treatments

Italian court OKs stem cell cure for toddler

(AP) MILAN - Doctors are preparing an emergency one-off stem cell treatment for 2-year-old Venetian girl suffering a severe muscular disease after a judge revoked an order blocking the cure.

Brescia hospital officials said Thursday the treatment for Celeste Carrer would begin within days. Carrer suffers from spinal muscular atrophy, which has a life expectancy of about two years. Her family reported marked improvement after beginning the experimental treatment this winter.

But the stem cell lab was shut down in May after Italy's drug agency determined it was not hygienic and had violated procedures. A judge in Venice has allowed one treatment pending a final ruling, expected next week, on the family's appeal.

Besides reactivating the lab, doctors must determine if the stem cells from the girl's mother remain viable.

Stem cells in tumors may fuel cancer regrowth, new studies suggest Timothy Ray Brown, man thought to be first "cured" of AIDS, says he's still cured 10-year-old girl gets new vein made from her own stem cells in medical first

Read the original:
Italian court OKs stem cell cure for toddler

Stem cell research may have application to treat autism

SACRAMENTO, Calif. Rydr Rudgers suffers from cerebral palsy. He couldnt move or talk before a cord blood stem cell treatment undertaken during a Duke University study.

His doctor, Michael Chez, M.D. is medical director of Pediatric Neurology at Sutter Neuroscience Institute. He is now heading up the first stem cell clinical trial on autism and hopes for similar results.

Dr. Chez says autism shares some of the same symptoms as cerebral palsy and that there is plenty of anecdotal evidence that using cord blood stem cells from the patients own umbilical cord can regenerate brain cells. The study which will employ placebos will determine scientifically whether such treatments make improvements in young autism patients.

Sutter Neuroscience Institute got FDA approval for the landmark study and will enroll 30 kids with autism age 2 to 7 to receive injections of their own stem cells. Most parents are given the option of saving their childrens ubilical cords after birth.

Elisa Rudgers is glas she did. Now four years old, Rydr is walking, talking and eating on his own. That wasnt possible without three stem cell therapy injections over several years. After each injection he made a marked improvement in motor skills.

Its amazing from where he started and we believe it has t do with the cord blood and all therapy hes gone thorugh since birth, said Rudgers.

Dr. Chez says such therapy is much safer than using randomly donated stem cells and has the potential to evolve into an effective autism treatment. Autism now strikes one in every 88 children born in the Unitied States, one in every 52 boys who are born.

Chez says its not known exactly how stem cells regenerate brain cell functions and that eventually a smaller portion of the stem material will be injected to fight the symtoms of autism.

Probably this will be looked back on as a crude first step but if we see progress it will lead to more progress, said Chez.

View original post here:
Stem cell research may have application to treat autism

Stem Cell Study to Enroll 30 Autistic Children

Lonnie Wong FOX40 News

1:53 p.m. PDT, August 21, 2012

SACRAMENTO

Rydr Rudgers suffers from cerebral palsy. He couldnt move or talk before a cord blood stem cell treatment undertaken during a Duke University study.

His doctor, Michael Chez, M.D. is medical director of Pediatric Neurology at Sutter Neuroscience Institute. He is now heading up the first stem cell clinical trial on autism and hopes for similar results.

Dr. Chez says autism shares some of the same symptoms as cerebral palsy and that there is plenty of anecdotal evidence that using cord blood stem cells from the patients' own umbilical cord can regenerate brain cells. The study which will employ placebos will determine scientifically whether such treatments make improvements in young autism patients.

Sutter Neuroscience Institute got FDA approval for the landmark study and will enroll 30 kids with autism age 2 to 7 to receive injections of their own stem cells. Most parents are given the option of saving their childrens' ubilical cords after birth.

Elisa Rudgers is glas she did. Now four years old, Rydr is walking, talking and eating on his own. That wasn't possible without three stem cell therapy injections over several years. After each injection he made a marked improvement in motor skills.

"It's amazing from where he started and we believe it has t do with the cord blood and all therapy he's gone thorugh since birth," said Rudgers.

Dr. Chez says such therapy is much safer than using randomly donated stem cells and has the potential to evolve into an effective autism treatment. Autism now strikes one in every 88 children born in the Unitied States, one in every 52 boys who are born.

See the original post here:
Stem Cell Study to Enroll 30 Autistic Children

Doctors to study newborn stem cells as treatment for autism

SACRAMENTO, CA - At 4-years-old Rydr Rudgers is able to eat, speak, and walk --all thingshis family wasn't sure he'd ever do after being diagnosed with cerebral palsy as an infant.

"He was born without any brain stem functions; no sucking, no swallowing, no breathing," said Rydr's mother Elisa.

When Rydr was 15-months-old, he began stem cell infusions from his cord blood that was saved in a stem cell bank.Rydris making great progress after three infusionsand can even feed himself.

"These are like huge milestones that people don't think about, but actually being able to hold a fork and eat a sandwich is, in our world, an unanticipated milestone and it's amazing," Elisa Rudgers explained.

"Like autism, cerebral palsy or brain injuries of that nature are a diffused population, it's not one cause,"said Dr. Michael Chez, who is the Medical Director of Pediatric Neurology at the Sutter Neuroscience Institute.

Doctors at the Sutter Neuroscience Institute are now beginning research to evaluate cord blood stem cells to help improve language and behavior in autism patients.

The announcement was made on Tuesday morning at Sutter Medical Plaza.It's the first FDA-approved clinical trial that uses a newborn's stem cells from cord blood to treat autism patients.

Doctors will infuse umbilical cord stem cells into the bloodstreams of 30 children diagnosed with autism.

"We feel it will offer a safe and effective answer to the question of whether the cord blood is an effective intervention as a way to introduce stem cell therapy for autism," Chez said.

Autism impacts one in 88 children and one in 54 boys. According to Sutter doctors, a newborn's umbilical cord blood contains a unique population of stem cells that have been used for more than 20 years in medical practice.

Link:
Doctors to study newborn stem cells as treatment for autism