Category Archives: Stem Cell Therapy

By Denise Mann HealthDay Reporter

THURSDAY, May 10 (HealthDay News) -- A new treatment that involves spinning bone marrow stem cells to enhance their healing potential may help people with advanced heart failure feel and function better, a small study suggests.

Researchers developed the treatment by culturing a patient's own bone marrow for 12 days. This process helped increase the amount of immune cells and stem cells that can differentiate into several different cell types, including heart cells. Those cells were then injected into heart muscle. The study was funded by treatment manufacturer Aastrom Biosciences.

According to the findings, this treatment was safe, helped repair the damaged heart muscle and reversed some heart failure symptoms, when compared to a placebo injection. The findings were to be presented Thursday at the Society for Cardiovascular Angiography and Interventions annual meeting, in Las Vegas.

The U.S. National Heart, Lung, and Blood Institute reports that about 5.8 million people in the United States have heart failure, a condition that occurs when the heart can no longer pump enough blood to meet the body's needs. Symptoms include shortness of breath, fatigue and swelling in the ankles, feet, legs and abdomen. There is no cure; treatment typically includes a cocktail of medications aimed at reducing symptoms and improving quality of life.

"A number of people with heart failure have slowly progressing disease despite medication and/or device therapy. If we could have a therapy for this group that would slow the progression of heart failure, it would be economic and change the disease process tremendously," said study author Dr. Timothy Henry, director of research and an interventional cardiologist at the Minneapolis Heart Institute at Abbott Northwestern Hospital in Minneapolis. The treatment would not be used for people who need a heart transplant.

Calling it the next generation of stem cell therapy, Henry said the treatment process helps enhance the potency of existing stem cells. "It gives a more functional product," and when injected these stem cells may promote the growth of new blood vessels, he added.

Further study is ongoing, and if the results are positive a product could be available within two years to treat inadequate blood supply to the legs, and soon thereafter for heart failure, he said. According to Henry, six or seven new products that enhance bone marrow stem cells are being developed. "Ask your doctor if you are a candidate for any of the clinical trials," Henry advised.

The new study included 22 participants with advanced heart failure and an enlarged heart whose current medication regimen was no longer effective. They either received an injection of the stem cell therapy treatment into their heart muscles or a placebo shot. After 12 months, there were no complications and no difference in side effects among those who received the stem cells and the control group. That said, individuals who received the novel stem cell therapy did have a lower number of major heart-related events and were more likely to see improvements in their ability to walk without growing breathless. Those who received the stem cell treatment also showed marked improvements in their ejection fraction, which is a measure of how much blood leaves the heart with each pump.

"This study tells us that injecting stem cells into the heart muscle of a patient with chronic heart failure may be beneficial," says Dr. Sandeep Jauhar, director of the congestive heart failure program at Long Island Jewish Medical Center in New Hyde Park, N.Y. Typically, these individuals are treated with multiple medications, put on a low-salt diet and encouraged to get some exercise.

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Stem Cell Study Shows Promising Results Against Heart Failure

ROCKVILLE, Md., May 8, 2012 /PRNewswire/ --Neuralstem, Inc. (CUR) announced that the Federal Drug Administration (FDA) has approved the return of three patients from earlier cohorts in its ongoing Phase I safety trial to treat amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) with its spinal cord stem cells (HSSC's). These patients will be permitted to return to the trial for second treatments as the next cohort of patients, provided they meet inclusion requirements at the scheduled time. They will be the first to receive stem cell transplantation along the length of the spinal cord.

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

The first twelve patients in the trial, which is taking place at Emory University Hospital in Atlanta, Georgia, received stem cell transplants in the lumbar (lower back) region of the spinal cord only. Thelast cohort of three, completed in April, received transplants in the cervical (upper back) region of the spinal cord, where stem cell transplantation could help support breathing, a key function that is lost as ALS progresses. The next cohort of three patients is designed to receive 10 HSSC injections in the lumbar region and 5 in the cervical, for a total of 15 injections along the length of the spinal cord. In the case of the returning patients, who have already received 10 lumbar injections, they will receive five cervical injections. These patients are between 15-17 months out from their first dosing and appear to have tolerated the first procedure well.

Additionally, Neuralstem has submitted a trial amendment to the FDA to increase both the number of patients treated as well as the dose in future cohorts. The amendment would also expand the trial to include certain efficacy endpoints. The trial was initially designed as a safety trial to treat 18 patients.

"The return of these patients to the trial for second treatments is a continuing validation of the trial's safety. Typically, Phase I trials do not bring study subjects back, as that could increase their exposure to potentially harmful treatments," said Karl Johe, PhD, Neuralstem Chairman and Chief Scientific Officer. "Treating these patients who have already received injections in one part of their spine allows us to both increase the overall dosage for each patient as well as transplant them in regions of the spine where they have not been treated," Dr. Johe continued. "Thisnext cohort of patients will be the first in the world to receive stem cell transplants in both cervical and lumbar regions of their spinal cord. With cervical injections of the lumbar patients, for example, we could also potentially support their breathing function, which is vital for preserving quality of life."

"Patients 10-12, who might return to the trial, were among those studied in a paper examining the first safety data from the trial, published online in STEM CELLS last month," 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. "As the paper showed, we believe that the cells and the route of administration are safe. It is a further validation of the safety profile to be able to bring patients back for additional dosing several months past the period which was reported on in the journal." Dr. Feldman is also principal investigator (PI) of the ALS trial and an unpaid Neuralstem consultant.

The FDA-approved amendment to the protocol requires approval of the Emory Institutional Review Board before it can be implemented.

About the Study

The ongoing Phase I study is designed to assess the safety of Neuralstem's spinal cord stem cells (HSSC's) and transplantation technique in up to 18 patients with amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease).

The first twelve patients were all transplanted in the lumbar (lower back) region of the spine. Of these, the initial six (Cohort A) were all non-ambulatory with permanent paralysis. The first patient was treated on January 20, 2010. Successive surgeries have followed at the rate of one every one-to-two months. The first three patients (Cohort A1) were each treated with five unilateral HSSC injections in L2-L4 lumbar segments, while the next three patients (Cohort A2) received ten bilateral injections (5 on each side) in the same region. The next six patients (Cohort B and C) were all ambulatory. Of these, the first three (Cohort B) received five unilateral injections in the L2-L4 region. The last three patients (Cohort C) in this study group received ten bilateral injections in the same region.

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Neuralstem Updates ALS Stem Cell Trial Progress

Regulated information May 8, 2012

TiGenix to Present at Key Conferences Spring 2012

Leuven (BELGIUM) - May 8, 2012 - TiGenix (TIG.BR), a leader in the field of cell therapy, announced today that during the months of May and June the company will present at a number of key events in Europe and the U.S. geared at investor, industry, and academic audiences to highlight the commercial potential of ChondroCelect, the only approved cell therapy in Europe, and of the company`s innovative proprietary allogeneic stem cell platform with programs in Phase I, II, and III for a range of inflammatory and autoimmune diseases.

May 15-16 BioEquity, Marriott Hotel, Frankfurt, Germany Presenter: Eduardo Bravo, CEO Date & time: Tuesday, May 15, 16:00-16:25 Room: Level 1, Room Gold 1

May 21-23 World Stem Cells and Regenerative Medicine Congress, Victoria Park Plaza, London, UK Presenter: Eduardo Bravo, CEO Date & time: Monday, May 21, 15:25 -15:50 Title: Cell Therapy & Regenerative Medicine - Progressing into phase III with an orphan indication

May 24 Knowledge for Growth, ICC Ghent, Belgium Presenter: Eduardo Bravo, CEO Time: 11:30 Keynote speech - Advanced therapies: this time it is for real

June 5-8 18th International Stem Cell Therapy Sociey Annual Meeting, Sheraton Seattle, WA, U.S. Presenter: Eduardo Bravo, CEO Date & time: June 7, 13:45-15:15 Title: Plenary Session 4 - Regenerative Medicine and Positioning for Commercial Success - Lessons from the commercial roll out of ChondroCelect in Europe

June 18-21 BIO International Convention, Boston Convention & Exhibition Center, MA, U.S. Presenter: Eduardo Bravo, CEO Date & time: June 20, 15:00-15:45 Title: Stem Cell Therapies...Fact or Fiction?

June 23 VFB Biotech Congres, Leuven, Belgium Location: Imec, Kapeldreef 75, Leuven Presenter: Gil Beyen, Chief Business Officer Time: 11am

June 23 Dag van de Biotechnologie, Leuven, Belgium Location: TiGenix headquarters, Leuven Event: Open day event throughout Flanders for all biotech companies & academic labs Time: 10am-5pm

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TiGenix : presenting at Key Conferences - Spring 2012

Public release date: 8-May-2012 [ | E-mail | Share ]

Contact: David Eve celltransplantation@gmail.com Cell Transplantation Center of Excellence for Aging and Brain Repair

Tampa, Fla. (May. 8, 2012) Two studies appearing in a recent issue of Cell Transplantation (20:11-12), now freely available on-line at http://www.ingentaconnect.com/content/cog/ct/, evaluate stem cells derived from dental tissues for characteristics that may make them therapeutically useful and appropriate for transplantation purposes.

Induced pluripotent stem cells from immature dental pulp stem cells

A Brazilian and American team of researchers used human immature dental pulp stem cells (IDPSCs) as an alternative source for creating induced pluripotent stem cells (iPSCs), stem cells that can be derived from several kinds of adult tissues. According to the study authors, production of iPSCs "opens new opportunities for increased understanding of human genetic diseases and embryogenesis" and will likely have a "great impact on future drug screening and toxicology tests."

The authors note, however, that the reprogramming methodology for making iPSCs is relatively new and "needs refining" in terms of technique, efficiency and cell type choice.

The researchers report that they easily, and in a short time frame, programmed human immature dental pulp stem cells into iPSCs with the hallmarks of pluripotent stem cells.

"Human IDPSCs can be easily derived from dental pulp extracted from adult or 'baby teeth' during routine dental visits," said study lead author Dr. Patricia C.B. Beltrao-Braga of the highly ranked National Institute of Science and Technology in Stem and Cell Therapy in Ribeirao Preto, Brazil. "hIDPSCs are immunologically privileged and can be used in the absence of any immune suppression protocol and have valuable cell therapy applications, including reconstruction of large cranial defects."

Contact: Dr. Patricia C.B. Beltrao-Braga, National Institute of Science and Technology in Stem Cell and Cell Therapy, 2051 Tenente Catao Roxo St. Ribeirao Preto, Brazil. Tel. 55 (11) 3091-7690 Email patriciacbbbraga@usp.br

Citation: Beltro-Braga, P. C. B.; Pignatari, G. C.; Maiorka, P. C.; Oliveira, N. A. J.; Lizier, N. F.; Wenceslau, C. V.; Miglino, M. A.; Muotri, A. R.; Kerkis, I. Feeder-free derivation of induced pluripotent stem cells from human immature dental pulp stem cells. Cell Transplant. 20(11-12):1707-1719;2011.

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2 Cell Transplantation studies impact dental stem cell research for therapeutic purposes

LEBANON Retired Dartmouth College professor Roger Smith said he had nothing to lose by joining a stem cell therapy clinical trial. In fact, if he didn't join, he did have something to lose possibly his leg.

In the end it appears the experiment saved his leg. And Smith, who'd already lost two toes to amputation, said he's proud to have played a part in a study that could dramatically improve the outcome for many other patients facing lower-limb amputations resulting from diabetes, high cholesterol, smoking, genetic predisposition and other causes.

The three-year study that ended last year was led by vascular surgeons at Dartmouth-Hitchcock Medical Center in Lebanon, who believe the treatment may offer new hope to sufferers of peripheral artery disease, a condition that causes nearly 60,000 lower-limb amputations every year.

Dr. Richard J. Powell, chief of vascular surgery at Dartmouth-Hitchcock, was the lead investigator of the second-phase national study, which included 72 patients from 20 different sites across the United States.

It's a winner, Powell said. For me, it was dramatic, because there has been nothing that has been shown to work. The results of the third-stage trial are to be presented to the Food and Drug Administration to be approved as a treatment for patients, Powell said.

Peripheral artery disease afflicts more than 9 million patients in the United States, according to Dartmouth-Hitchcock. The condition results from blockages in blood vessels caused by atherosclerosis hardening of the arteries. Options for these patients are limited to the insertion of stents or bypass surgery.

And for about 150,000 patients in the United States who have the most severe form of the disease, amputation is the only option. The results of this recent study suggest amputation could be prevented in the majority of these severe cases.

And if the third phase of the clinical trials confirms the earlier results, the lives of those patients with severe cases could be tremendously affected, Powell said.

This is the first potential treatment that is non-surgical for really severe cardiovascular disease in the legs, he said. Roger Smith's story

About six years ago, Smith, 79, said he was having pain in his leg and trouble sleeping. He was initially misdiagnosed as having the nerve-related condition referred to as spinal stenosis, more commonly known as sciatica. When his condition worsened, he was correctly diagnosed with advanced peripheral artery disease. He lost two of his toes to amputation and was in danger of losing his leg.

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Treatment spares Lebanon man from amputation