Author Archives: admin


Stem Cell Clinic > Articles by: admin

Gazette.Net: Osiris scores approval down under for stem cell drug

By Stem Cell Treatment

Osiris Therapeutics has won a second nations imprimatur for its stem cell treatment for a deadly complication of bone marrow transplants in children.

Following Canada's lead last month, New Zealand this week gave the Columbia company marketing approval for Prochymal to treat pediatric graft-vs.-host disease, Osiris reported. Canada was the first internationally recognized regulatory body to approve a stem cell drug.

The disease kills up to 80 percent of children who contract it, many within weeks of diagnosis.

"With each of our approvals it becomes clearer that the time for life-saving stem cell therapies in the practice of medicine has arrived, and we are humbled to have a leading role, CEO C. Randal Mills said in a company statement.

More cases of the disease are expected "as the demographic profile of our transplant population evolves," Hans Klingemann, professor of medicine and director of the Bone Marrow & Hematopoietic Stem Cell Transplant Program at Tufts University School of Medicine, said in the statement. "Effective strategies to manage the often lethal consequences of [graft-vs.-host disease] reduce the overall risk to transplantation ..."

Osiris applied for marketing approval in New Zealand in May 2011 and was given priority review the following month.

Besides Canada and New Zealand, Prochymal is available in the U.S. and several other nations under special patient circumstances.

The company also is testing the drug as a treatment for Crohns disease, heart attacks and type 1 diabetes.

In other Maryland bioscience industry news:

Sanaria, working with University of Maryland researchers, has won a three-year federal grant worth almost $3 million to genetically engineer mosquitoes for the Rockville biotech's malaria vaccine manufacturing program.

View original post here:
Gazette.Net: Osiris scores approval down under for stem cell drug

Stroke patients 'healed' by controversial stem cell injections that have improved movement and allowed one to speak

By Stem Cell Treatment

By Fiona Macrae

PUBLISHED: 19:48 EST, 14 June 2012 | UPDATED: 19:48 EST, 14 June 2012

The pioneering treatment could revolutionise stroke rehabilitation (picture posed by model)

The first stroke patients to have a pioneering and controversial stem cell treatment have shown tantalising signs of improvement.

The five men have seen improvements in their ability to move, and in one case, speak, after millions of stem cells from an aborted 12-week-old baby were injected into their brains up to 18 months ago.

However, the treatment has provoked criticism from campaigners who say that the use of aborted tissue cannot be justified, whatever the benefits to the patient.

The trial, spearheaded by Surrey-based biotech firm ReNeuron and carried out at Glasgows Southern General Hospital, was the first in the world to give brain cells to stroke patients.

The treatment capitalises on the power of stem cells, dubbed master cells, which have the ability to multiply repeatedly and transform into other cell types, acting as a repair kit for the body.

Experts cautioned that the work is at a very early stage, but added that even the smallest of improvements can make a huge difference to someone who has been robbed of the ability to dress or feed themselves.

Go here to read the rest:
Stroke patients 'healed' by controversial stem cell injections that have improved movement and allowed one to speak

Six new stem cell lines now publicly available

By Stem Cell Treatment

ScienceDaily (June 14, 2012) Six new human embryonic stem cell lines derived at the University of Michigan have just been placed on the U.S. National Institutes of Health's registry, making the cells available for federally-funded research.

U-M now has a total of eight cell lines on the registry, including five that carry genetic mutations for serious diseases such as the severe bleeding disorder hemophilia B, the fatal brain disorder Huntington's disease and the heart condition called hypertrophic cardiomyopathy, which causes sudden death in athletes and others.

Researchers at U-M and around the country can now begin using the stem cell lines to study the origins of these diseases and potential treatments. Two of the cell lines are believed to be the first in the world bearing that particular disease gene.

The three U-M stem cell lines now in the registry that do not carry disease genes are also useful for general studies and as comparisons for stem cells with disease genes. In all, there are 163 stem cell lines in the federal registry, most of them without major disease genes.

Each of the lines was derived from a cluster of about 30 cells removed from a donated five-day-old embryo roughly the size of the period at the end of this sentence. The embryos carrying disease genes were created for reproductive purposes, tested and found to be affected with a genetic disorder, deemed not suitable for implantation and would have otherwise been discarded if not donated by the couples who donated them.

Some came from couples having fertility treatment at U-M's Center for Reproductive Medicine, others from as far away as Portland, OR. Some were never frozen, which may mean that the stem cells will have unique characteristics and utilities.

The full list of U-M-derived stem cell lines accepted to the NIH registry includes:

"Our last three years of work have really begun to pay off, paving the way for scientists worldwide to make novel discoveries that will benefit human health in the near future," says Gary Smith, Ph.D., who derived the lines and also is co-director of the U-M Consortium for Stem Cell Therapies, part of the A. Alfred Taubman Medical Research Institute.

"Each cell line accepted to the registry demonstrates our attention to details of proper oversight, consenting, and following of NIH guidelines," says Sue O'Shea, Ph.D., professor of Cell and Developmental Biology at the U-M Medical School, and co-director of the Consortium for Stem Cell Therapies.

U-M is one of only three academic institutions to have disease-specific stem cell lines listed in the national registry, says Smith, who is a professor in the Department of Obstetrics and Gynecology at the University of Michigan Medical School. The first line, a genetically normal one, was accepted to the registry in February.

Read more from the original source:
Six new stem cell lines now publicly available

Stem cell treatment helps heal stroke victims

By Stem Cell Treatment

"So it's interesting to see that in all the patients so far they have improved slightly over the course of their involvement in the study."

The six patients suffered strokes between six months and five years before they were treated, and all had been left with limb weakness.

The patients were assessed using the National Institutes of Health Stroke Scale which ranked the first five patients with a median score of eight before the treatment and four points three months afterwards.

The sixth patient was treated less than three months ago. Six further patients will be treated as part of this Phase 1 trial.

Professor Muir said he was "intrigued" by the early results.

He added: "We know that if you're involved in a trial you are going to see patients change in behaviour, particularly if you're doing something invasive, so we need to be very cautious indeed in interpreting these results.

"However, that said, it is not something we'd anticipated seeing in this group of patients."

Further trials are needed to establish whether stem cells actually help the brain repair damaged tissue.

Michael Hunt, chief executive officer of the company developing the treatment, ReNeuron, said: "The clinical trial is primarily a safety study and we must therefore treat any of the observed early indications of functional benefit with considerable caution at this stage.

"That said, we remain encouraged by the results seen in the study to date and we look forward to providing further updates."

Go here to read the rest:
Stem cell treatment helps heal stroke victims

10-year-old girl gets new vein made from her own stem cells in medical first

By Stem Cell Doctors

(CBS News) A 10-year-old girl made medical history when a vein created from her own stem cells was transplanted into her body to treat a life-threatening blockage.

PICTURES: First lab-grown windpipe saves cancer patient

The girl had a condition called hepatic portal vein obstruction in which there is a blockage in the vein that drains blood from the intestines and spleen to the liver. A blockage here can lead to major complications like bleeding, developmental delays, an enlarged spleen and even death. Typical treatments include removing veins from other parts of the body - such as the leg - and transplanting them elsewhere to restore blood flow, but the procedures can be risky and have had mixed success.

For the new procedure, the girl was admitted to the Sahlgrenska University Hospital in Gothenburg, Sweden, where a team had already taken a 9 centimeter segment of vein from the groin of a deceased donor. The doctors stripped all cells from the vein, leaving just a tube of scaffolding, which was then injected with stem cells obtained from the girl's own bone marrow. After two weeks in a bioreactor, the graft was re-implanted in the 10-year-old girl, and her condition has been improving ever since.

The medical milestone is described in the June 14 issue of the The Lancet.

"The young girl in this report was spared the trauma of having veins harvested from the deep neck or leg with the associated risk of lower limb disorders," and avoided the need for a liver transplant, explained Dr. Martin Birchall, chair of laryngology, and Dr. George Hamilton, professor of vascular surgery, both at the University College London, U.K., in a commentary published in the same issue.

The girl had no complications from the operation and her blood flow was restored immediately.

In the year since the procedure, the girl has grown from about 4 feet 4.5 inches to almost 4 feet 7 inches and her weight increased from 66 pounds to 77 pounds. However over that year her blood flow decreased and the graft narrowed, requiring a second stem cell-based procedure. She has remained well since the second procedure, taking long walks of up to two miles and participating in light gymnastics. Especially noteworthy is her immune system has not attempted to fight off the donor tissue, despite her not taking any immunosuppressive drugs which often carry side effects.

"The new stem-cells derived graft resulted not only in good blood flow rates and normal laboratory test values but also, in strikingly improved quality of life for the patient," wrote the surgeons, led by Dr. Michael Olausson, a profsesory of surgery at the University of Gothenburg in Sweden. They added that their work opens up the possibility of trying to reproduce arteries for surgical use, such as for coronary bypass surgery.

This isn't the first procedure to use a patient's stem cells to create new tissue to save a person's life. HealthPop reported in 2011 of an Eritrean man with late-stage throat cancer who received the world's first synthetic windpipe. The organ was grown from the man's stem cells and then applied to a plastic scaffold, eliminating the need for a donor organ.

Here is the original post:
10-year-old girl gets new vein made from her own stem cells in medical first

Lab-grown vein transplant marks another milestone in stem cell research

By Stem Cell Doctors

In a first, doctors in Sweden have transplanted into the body of 10-year-old girl a vein grown in the laboratory from her own stem cells.

The core team that performed the procedure was led by Dr Suchitra Holgersson, a transplant medicine scholar originally from Mumbai, and included four other doctors from India. The landmark transplant was published in the British medical journal The Lancet on Thursday.

The child had a blockage in her extrahepatic portal vein, which was obstructing blood supply to her liver. Options available to doctors included a liver transplant or taking a vein graft from the umbilical cord of a donor, which would have led to lifelong dependence on immunosuppressants.

A third alternative was to graft another vein usually from the leg or neck onto the liver vein. This is associated with risks of lower limb disorders, and was not considered a viable option due to the girls young age.

Speaking to The Indian Express by telephone, Dr Holgersson, a professor in the department of transplant and regenerative medicine at Sahlgrenska Science Park in Gothenburg University, said: We took a 9-centimetre graft from a deceased donor and removed all its original cells, leaving a hollow piece of vein. We then extracted stem cells of two kinds from the bone marrow of the little girl endothelial and smooth muscle cells gave it necessary growth factors, and let it incubate for two weeks.

This manufactured vessel was then transplanted into the girl. Blood flow to the liver started immediately after the procedure, and since the stem cells were the patients own, there was no fear of an adverse immune reaction either, and she needs no drugs, Dr Holgersson said.

... contd.

Read the original:
Lab-grown vein transplant marks another milestone in stem cell research

Doctors Use Stem Cells To Grow Vein For Young Patient

By Stem Cell Doctors

June 14, 2012

Brett Smith for redOrbit.com

A successful transplant operation in Sweden points to a medical future where your doctor can grow a transplant organ from your own cells, making organ donation a thing of the past.

Doctors have now successfully transplanted a vein grown with a patients own stem cells without complications or the need for immunosuppressants, according to a report published this week in The Lancet. The patient was a 10-year-old girl in Sweden who was suffering from a potentially fatal blockage in the vein which drains blood from the intestines and spleen to the liver.

Last March, a team of doctors at the University of Gothenburg decided to grow the new blood vessel used to bypass the blocked vein instead of using an invasive neck or leg surgery to extract one of her own.

The young girl in this report was spared the trauma of having veins harvested from the deep neck or leg with the associated risk of lower limb disorders, and avoided the need for a liver or multivisceral transplantation, Martin Birchall and George Hamilton of University College London wrote in The Lancet.

To start the procedure, doctors took a three-inch section of a cadaver groin vein and stripped it of all living cells, leaving only an inert protein structure. The team then injected it with blood-forming stem cells taken from the girls bone marrow. After growing the vein for two weeks in an incubator, the stem cells had multiplied and converted into vein wall cells, to create a biologically-engineered replacement. The new vein was then implanted into the patient a year ago.

The new stem-cells derived graft resulted not only in good blood flow rates and normal laboratory test values but also, in strikingly improved quality of life for the patient, the report said.

In noting the success of the transplant, the doctors reported that the patient grew 2 inches and gained 11 pounds over the following year. In addition, her parents said that she was more physically active, had improved articulated speech, and had concentrated better on her studies.

The only major complication was the slight constriction of the vein nine months after the operation, which was corrected in a follow-up procedure. During the course of following up on the operation, scientists found no antibodies for the donor vein in the girls blood. This meant her body was not rejecting the transplant because it was recognized as being made of her own cells.

Link:
Doctors Use Stem Cells To Grow Vein For Young Patient

Team devises stem-cell method for retinal tissue

By Stem Cell Medicine

KOBE A method to generate multilayered retinal tissue from human embryonic stem cells, developed by a Japanese biological research unit and Sumitomo Chemical Co., has been published in the June 13 edition of the U.S. scientific journal Cell Stem Cell.

It is the first time multilayered retinal tissue has been developed from human ESCs. In the article, the research team at the Riken Center for Developmental Biology and Sumitomo Chemical said, "We demonstrate that an optic cup structure can form by self-organization in human ESC culture."

The method could be applied to regenerative medicine by transplanting the tissue generated to treat conventionally incurable eye diseases such as retinitis pigmentosa, an inherited, degenerative eye disease that causes severe visual impairment and blindness.

"Human ESC-derived neural retina grows into multilayered tissue containing both rods and cones, whereas cone differentiation is rare in mouse ESC culture," the article said.

The researchers developed a method to generate a large amount of such tissue in a short period of time as well as a method that enables en bloc cryopreservation of stratified neural retina of human origin, with useful applications.

Kyodo

LONDON Japanese scientist Shinya Yamanaka has received this year's Millennium Technology Prize for his discovery of a new method to produce induced pluripotent stem cells at a ceremony in Helsinki.

He shared the prize with Finland's Linus Torvalds, 42, who developed the Linux open-source computer operating system. They will split the ?1.2 million in prize money, given by Technology Academy Finland, a foundation partially funded by the Finnish government.

More here:
Team devises stem-cell method for retinal tissue

Millennium Highlights Updated Survival Data from ADCETRIS® (Brentuximab Vedotin) Pivotal Trial in Patients with …

By Stem Cell Medical Center

CAMBRIDGE, Mass.--(BUSINESS WIRE)--

Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), today announced updated survival data from a pivotal Phase II clinical trial of single-agent brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma (HL) after autologous stem cell transplant (ASCT) showing that the median overall survival has not been reached after a 26.5 month median follow-up. The data will be reported during an oral presentation at the 17th European Hematology Association (EHA) Annual Meeting being held June 14-17, 2012 in Amsterdam, Netherlands. Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of the majority of types of HL.

Heavily pretreated Hodgkin lymphoma patients who relapse following autologous stem cell transplant often have a poor prognosis and there is a high unmet medical need for effective treatment options, said Scott Smith M.D., Ph.D., Loyola University Medical Center. These updated overall survival results from the pivotal trial are encouraging and suggest that brentuximab vedotin may play an important role in the treatment of patients with relapsed or refractory disease.

Long-term Follow-up Results of an Ongoing Pivotal Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Hodgkin Lymphoma

A pivotal trial was conducted in 102 patients with relapsed or refractory HL after ASCT. The primary endpoint was objective response rate (ORR) per independent review. The secondary endpoints were complete remission (CR) rate, duration of response, progression-free survival (PFS), overall survival (OS), and safety and tolerability. At the time of the long-term follow-up analysis, the median observation time from first dose was 26.5months. Data, to be presented by Dr. Smith, include:

Patients received 1.8milligrams per kilogram of brentuximab vedotin every 3 weeks as a 30-minute outpatient intravenous infusion for up to 16cycles. Patients received a median of nine cycles of brentuximab vedotin while on trial. The median age of patients in the pivotal trial was 31 years. Enrolled patients had received a median of 3.5 (range 113) prior cancer-related systemic therapies, excluding ASCT. Seventy-one percent of patients had primary refractory disease, defined in the study protocol as patients who relapsed within three months of attaining CR or failed to achieve a CR, and 42 percent had not responded to their most recent prior therapy.

Details of the oral presentation are as follows:

About Brentuximab Vedotin

Brentuximab vedotin is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

Brentuximab vedotin is not approved for use outside the United States. The marketing authorization application for brentuximab vedotin in relapsed or refractory Hodgkin lymphoma and sALCL, filed by Takeda Global Research & Development Centre (Europe), was accepted for review by the European Medicines Agency for review in June 2011.

Link:
Millennium Highlights Updated Survival Data from ADCETRIS® (Brentuximab Vedotin) Pivotal Trial in Patients with ...

Harvard To Resume Allston Science Center Development in 2014

By Stem Cell Clinic

After halting construction on its Allston science center more than two years ago, Harvard announced on Wednesday that it will resume development in 2014.

The facility, which will be called the Health and Life Science Center, will house academic projects for stem cell science and engineering and physical sciences.

Douglas A. Melton, a co-director of theHarvard Stem Cell Instituteand co-chair of the Harvard stem cell and regenerative biology department, added that this development "should leadto the kinds of collaborations and exciting advances, and interesting experiments in undergraduate teaching, that otherwise might not take place."

Previous plans for the new science center included stem cell science, but the second componentengineering and physical sciences with application to biological and life sciencesis new.

By allowing stem cell scientists and bioengineers with common goals to work literally side-by-side, in close proximity to the I-Lab and Business School, Harvard will be hastening the day discoveries in our labs can be moved into the clinic, where they will benefit patients, Melton said in a statement.

Associate Vice President for Public Affairs and Communications Kevin Casey, who presented the plan at a Harvard-Allston Task Force meeting, told attendees that that the complex would likely be 500,000 to 600,000 square feet in size,providing office space for 500 scientists and an additional support staff.

Harvard halted construction in Allston in 2009 following a credit crunch caused by the 2008 recession. Allston planning restarted in December 2011.

According to Harvard Executive Vice President Katherine N. Lapp, Harvard hopes to begin readying its Western Avenue site forconstruction towards the end of 2013.

"The Health and Life Science Center will represent the single largest investment in a science facility ever made by Harvard, and the biggest investment in science space envisioned for at least the next decade," Lapp wrote in a public update.

Harvard officials also updated Task Force members on the progress of its other efforts in Allston. University officials said that they will work with Boston-based Samuels & Associates to develop residential and retail spaces in Barrys Corner, few blocks away from the future site of the Health and Life Science Center.

See more here:
Harvard To Resume Allston Science Center Development in 2014

→←