Category Archives: Cell Therapy

Cardiac cellular therapies are undergoing global clinical trials with "encouraging early results" and these economical options will soon be available in India which could bring relief to patients who cannot afford the currently available expensive surgical treatments, says Indian American cardiac surgeon Dr Mukesh Hariawala.

Delivering a special invited plenary lecture on the "Novel Cellular Therapies for Heart Disease" at the recently concluded Healthcare India 2012 convention in New Delhi, the renowned cardiac surgeon asserted that the new developments in cardiac cellular therapies would bring down the alarming healthcare costs globally.

Dr Hariawala is internationally acclaimed as a pioneer of cardiovascular surgical techniques using Therapeutic Angiogenesis. He said Therapeutic Angiogenesis is a fast emerging science of stimulating growth of new blood vessels in the heart which acts as natural bypasses to areas lacking in blood supply.

Dr Hariawala demonstrated angiogenesis along with bypass surgery, lasers and stem cell injections as a novel "Combo Therapy."

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The laser energy acts by creating channels in the diseased heart muscle which also triggers Angiogenesis. Stem cells are then injected directly into coronary arteries feeding the diseased territory or in the stimulated lasered muscle during the open heart surgery. This option could be very helpful in Indian patients with diffused distal small caliber coronary arteries and diabetes, who are not amicable to routinely offered current interventions, he said.

Dr Hariawala acknowledged that only a combination of these four therapies could give it the "Therapeutic Threshold Power" and bring about optimum results and relief of patients symptoms. Standalone, each of these therapies is weak to treat a large muscular pumping organ like the heart.

Stem cells have a therapeutic role and hold enormous promise for the future as they are harvested from the patient's own tissues. Currently, adult stem cell extraction is done from one's own hip bone and patients do not have to worry about rejection phenomenon occurring as they are native cells unlike transplanted from another donor. In the future, stem cell banks could proliferate allowing donors to freeze and store cells for family members who could be treated for many diseases, he added.

Harvard-trained Dr Hariawala's studies have been published in several scientific surgical journals and medical text books.

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Angiogenesis and Stem Cell Therapy Key to Treating Heart Patients: Dr Mukesh Hariawala

LONDON (Reuters) - Britain's Nuffield Council on Bioethics, which examines ethical issues raised by new developments in biology and medicine, launched a consultation on Thursday on the ethics of new technologies and devices that intervene in the human brain.

The three main areas of the group's focus are brain-computer interfaces, neurostimulation and neural stem cell therapy.

Here are some details about each area of research and how it is being explored.

* Brain computer interfaces (BCIs)

BCIs measure and analyze a person's brain signals and convert them into an output such as movement.

A paralyzed person, for example, could use a BCI to operate a wheelchair, or someone who has extreme difficulty speaking could use a BCI to communicate via a computer voice.

These sorts of applications have been shown to be successful in a few reported cases, but the technology has not yet been developed for regular clinical use and there are questions over whether these technologies are reliable enough for use in everyday life.

Military applications, such as remote control of vehicles and machinery are not yet in wide use but are being researched and tested, mainly in the United States.

Some commercial BCI developments are already on the market in the gaming sector. Gamers can buy a wireless headset that aims to replace a joystick by controlling game play through brain signals.

The use of BCIs sometimes require surgery to implant electrodes into a person's brain, although the most successful current developments are less invasive ones That detect brain signals from the scalp.

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Factbox: Neurotechnologies in spotlight of UK ethics review

SILVER SPRING, Md.--(BUSINESS WIRE)--

Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, announced today Goldman Small Cap Research has reissued its buy recommendation on Nuvilex with a short term price target of $0.50 per share.

According to the research report prepared by Goldman, The current share price represents but a fraction of its true value, in our view. With recently increased interest and valuation in the pancreatic cancer treatment arena, we believe that Nuvilex is worth $0.20 just on the oncology therapies alone and that the shares will reach $0.50 in the next six months. Looking ahead, as milestone events occur, $1.00 per share is within reach over the next 12-18 months.

Goldman bases this value projection, in part, on the pending acquisition of SG Austria assets, and with it complete control over the cell encapsulation technology that forms the backbone of Nuvilexs planned biotechnology development. The report states in part the following:

Following execution of the SG Austria asset acquisition, we expect to see a flurry of events and progress on the development side which will serve as catalysts, including when management submits its protocol for the next stage pancreatic cancer trial. We would not be surprised to see the stock break through the $0.50 price on such news as well as progress on the next stage of trials for other therapies.

One reason we are so convinced of the great buying opportunity is the fact that pancreatic cancer treatments are currently at the forefront of the biotech space and are enjoying very high valuations. Although Nuvilex is a not a drug producer, but an existing therapy enhancer through the use of its live cell encapsulation enhancement platform, the timing of these milestone events could not be better for Nuvilex and a re-valuation of its offering.

The Goldman report also compares alternative oncology therapies, including Gemzar from Threshold Pharmaceuticals and Merrimack Pharmaceuticals drug encapsulation technology, noting that, contrary to these treatments, the Nuvilex live-cell encapsulation technology is not limited to one specific use, but can be adapted to use for a host of cell types. The report states, Its difficult to compare apples-to-apples in this space as Nuvilex is the only firm utilizing live-cell encapsulation therapy for cancer, while all the other treatments are based upon a particular drug usage. Contrasting the results of different Phase II clinical trials, the Goldman report comments that the pancreatic cancer therapy, based on completed Phase 1/2 data, appears to have yielded statistically greater results than competing technologies.

Commenting on The Goldman Report, Nuvilex Chief Executive Officer, Dr. Robert Ryan, stated, The report did an excellent job highlighting the value and capabilities of our cell encapsulation technology, not just for cancer therapy, but also for the vast array of treatments where live-cell encapsulation can aid multiple diseases. In the case of the completed cancer trials, it generated superior results with lower drug dosages, and reduced chemotherapeutic side effects. As we move forward with diabetes and stem cell therapy treatments, we are confident our success will, as Goldman predicts prompt leaders in multiple treatment segments to partner with Nuvilex in order to maintain their respective market shares.

Investors are recommended to study the Goldman Research Report for a detailed review and valuation methodology regarding Nuvilex.

About Nuvilex

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Nuvilex Reveals Goldman Small Cap Research Cites Groundbreaking Cancer Therapy in Updating Buy Recommendation

By David Cyranoski of Nature magazine

With Texas pouring millions of dollars into developing adult stem-cell treatments, doctors there are already injecting paying customers with unproven preparations, supplied by an ambitious new company.

The US Food and Drug Administration (FDA) has not approved any such stem-cell treatment for routine clinical use, although it does sanction them for patients enrolled in registered clinical trials. Some advocates of the treatments argue, however, that preparations based on a patient's own cells should not be classed as drugs, and should not therefore fall under the FDA's jurisdiction.

There are certainly plenty of people eager to have the treatments. Texas governor Rick Perry, for instance, has had stem-cell injections to treat a back complaint, and has supported legislation to help create banks to store patients' harvested stem cells.

One company that has benefited from this buoyant climate is Celltex Therapeutics, which "multiplies and banks" stem cells derived from people's abdominal fat, according to chairman and chief executive David Eller. Its facility in Sugar Land, just outside Houston, opened in December 2011 and houses the largest stem-cell bank in the United States.

Celltex was founded by Eller and Stanley Jones, the orthopaedic surgeon who performed Perry's procedure, and it uses technology licensed from RNL Bio in Seoul. Because clinical use of adult-stem-cell treatments are illegal in South Korea, RNL has since 2006 sent more than 10,000 patients to clinics in Japan and China to receive injections.

Celltex says that although it processes and banks cells, it does not carry out stem-cell injections. It declined to answer Nature's questions about whether its cells have been used in patients. But there is evidence that the company is involved in the clinical use of the cells on US soil, which the FDA has viewed as illegal in other cases.

Public hype

In addition to the publicity surrounding Perry's treatment, a woman named Debbie Bertrand has been blogging about her experiences during a five-injection treatment with cells prepared at Celltex. Her blog (http://debbiebertrand.blogspot.com) hosts photographs of herself alongside Jones; Jennifer Novak, a Celltex nurse; Jeong Chan Ra, chief executive of RNL Bio; and her doctor, Jamshid Lotfi, a neurologist who works for the United Neurology clinic in Houston. Another photo is captioned: "My cells are being processed in here for my next infusion!!!" A third shows Bertrand, Lotfi and a physician called Matthew Daneshmand, who is, according to the caption, injecting Bertrand's stem cells into an intravenous drip, ready for the infusion. Nature has been unable to contact Bertrand.

Lotfi says that he has administered cells processed by Celltex to more than 20 people. "Five or six" -- including Bertrand -- have multiple sclerosis and "four or five" have Parkinson's disease, he says. Lotfi explains that patients sign up for treatment by contacting Novak, and that cells are prepared by removing about five grams of fat -- containing roughly 100,000 mesenchymal stem cells -- from the patient's abdomen. Over a three-week period, the cells are cultured until they reach about 800 million cells. Lotfi says that patients get at least three injections of 200 million cells each, and that the cells do not take effect for a few months. According to Lotfi, Celltex charges US$7,000 per 200 million cells, and pays Lotfi $500 per injection.

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Stem-Cell Therapy Takes Off in Texas

Allegheny-Kiski Health Foundation will present "Stem-Cell Therapy: Defeating the Aging Process" from 6 to 8 p.m. March 13 in the William & Grayce Walker conference Room at Allegheny-Kiski Health Foundation, Charles and Mary Lou Young Non-Profit Center, 1 Acee Drive, Natrona Heights.

Guest speaker will be Dr. Valerie Donaldson of the Individualized Advanced Medical Center of Pittsburgh. She is active in destressing the body and focusing on the anti-aging process.

Donaldson completed her undergraduate education at Colorado College where she earned a bachelor's degree in biology and obtained her doctorate at Rush Medical College in Chicago.

Registration is requested. Call 724-294-3157. Admission is free.

The seminar is sponsored through the Dr. H.W. Fraley Health and Wellness Fund.

Programs set at Destination Wellness

Upcoming programs at Allegheny Valley Hospital's Destination Wellness at Pittsburgh Mills, Frazer, include:

Pittsburgh North Restless Legs Syndrome Support Group will meet from 6:15 to 7:45 p.m. Dr. Avinash Aggarwal will discuss "Is it RLS or Something Else?" To register, call Destination Wellness at 724-274-5202.

Heartsaver First Aid, part one will be from 9 a.m. to noon March 10 and is the basic first-aid course. A two-year certification card will be given after completion of skills and written testing. Fee is $35 per part and includes a required student manual. Call 724-274-5202 to register. Space is limited to eight participants.

Heartsaver AED/CPR, part two will be from 1 to 4 p.m. March 10 and includes adult, child and infant CPR and automated external defibrillator use. A two-year certification card will be given after completion of skills and written testing. Fee is $35 per part and includes required student manual. Call 724-274-5202 to register. Space is limited to eight participants.

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Program looks at stem-cell therapy to defeat aging

28-02-2012 14:48 Albert Rodriguez, MD administers stem cell therapy for Hereditary Spastic Paraplegia. stemcelldrR.com, email airpainmd@aol.com

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Stem Cell Therapy Procedure and Outcome - Video

DEERFIELD, Ill.--(BUSINESS WIRE)--

Baxter International Inc. (NYSE:BAX - News) announced today that it has initiated a phase III pivotal clinical trial to evaluate the efficacy and safety of adult autologous (an individual’s own) CD34+ stem cells to increase exercise capacity in patients with chronic myocardial ischemia (CMI).

Chronic myocardial ischemia (CMI) is one of the most severe forms of coronary artery disease, causing significant long-term damage to the heart muscle and disability to the patient. It is often diagnosed based on symptoms of severe, refractory angina, which is severe chest discomfort that does not respond to conventional medical management or surgical interventions.

“The prospect of using a person’s own adult stem cells to restore and repair blood flow in CMI is a very exciting concept based on a biological regenerative approach,” said Norbert Riedel, Ph.D., Baxter’s chief science and innovation officer. “The goals of this phase III trial are aligned with Baxter’s overall mission to develop life-saving and life-sustaining therapies and it will help us determine if the therapy can make a meaningful difference for CMI patients.”

The trial will enroll approximately 450 patients across 50 clinical sites in the United States, who will be randomized to one of three arms: treatment with their own autologous CD34+ stem cells, treatment with placebo (control), or unblinded standard of care. The primary objective is to evaluate the efficacy of treatment with CD34+ stem cells to improve the functional capacity of patients with CMI, as measured by a change in total exercise capacity at 12 months following treatment. Secondary objectives include reduced frequency of angina episodes at 12 months after treatment and the safety of targeted delivery of the cells.

After stem cell mobilization, apheresis (collecting the cells from the body) and cell processing, participants will receive CD34+ stem cells or placebo in a single treatment via 10 intramyocardial injections into targeted areas of the heart tissue. Efficacy will be measured by a change in total exercise capacity during the first year following treatment and safety data will be collected for two years. Stem cell processing will be conducted in GMP facilities in the United States by Progenitor Cell Therapy (PCT), a subsidiary of NeoStem, Inc. To learn more or enroll, visit http://www.renewstudy.com or http://www.clinicaltrials.gov.

This trial is being initiated based on the phase II data, which indicated that injections of patients’ own CD34+ stem cells may improve exercise capacity and reduce reports of angina episodes in patients with chronic, severe refractory angina.

“The phase II trial provided evidence that this strategy, leveraging the body’s own natural repair mechanisms, can improve exercise capacity and reduce chest pain, the first time these endpoints have been achieved in a population of patients who have exhausted conventional treatment options,” said Douglas Losordo, MD, vice president of new therapeutic development at Baxter.

CD34+ cells, which are blood-forming stem cells derived from bone marrow, are comprised of endothelial progenitor cells (EPCs), which develop into new blood vessels. Previous preclinical studies investigating these cells have shown an increase in capillary density and improved cardiac function in models of myocardial ischemia.

About Baxter

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

This release includes forward-looking statements concerning the use of adult autologous stem cells to treat CMI, including expectations with respect to the related phase III clinical trial. These statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: clinical results demonstrating the safety and effectiveness of the use of autologous stem cells to treat CMI; timely submission of regulatory filings; satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; the enrollment of a sufficient number of qualified participants in the phase III clinical trial; the successful provision of stem cell processing by PCT, a third party; and other risks identified in Baxter’s most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter’s website. Baxter does not undertake to update its forward-looking statements.

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Baxter Initiates Phase III Adult Stem Cell Clinical Trial for Chronic Cardiac Condition