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Category Archives: Stem Cell Therapy

Nuvilex Announces Major Breakthrough in Stem Cell Research

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

Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, released information today about the companys cell encapsulation technology and the breakthrough in stem cell research which overcomes specific fundamental challenges faced in stem cell therapyhost rejection and migration of implanted cells away from the target site.

Stem cell therapy is believed by many medical researchers as holding a key to treating cancer, Type 1 diabetes mellitus, Parkinson's disease, Huntington's disease, Celiac Disease, cardiac failure, muscle damage, neurological disorders, and other chronic, debilitating diseases. There are presently >1,400 registered trials using stem cells that are recruiting patients (ClinicalTrials.gov). The encapsulation technology being advanced allows live stem cells to be implanted into robust, flexible and permeable capsules where they can replicate inside the capsules at the target site free from attack by the bodys immune system and free to undergo natural changes to become the appropriate cell type needed.

The Goldman Small Cap Research report, issued February 29, 2012, noted some inherent difficulties encountered in stem cell treatments, such as keeping stem cells alive for significant periods of time, potential rejection of the cells and subsequent destruction by the recipients immune system, and the migration of the stem cells away from the critical treatment site, while making a distinction that the Companys cell encapsulation technology overcomes these concerns.

The report also accurately recognized, Cells encapsulated in SG Austrias porous beads remain alive for long periods of time in humans, surviving intact for at least two years. Once encapsulated, cells are protected from the bodys immune system. Furthermore, encapsulated cells remain within the beads and do not migrate out of the beads to other sites in the body.

In assessing the overall importance of this technology to Nuvilexs overall business model, Goldman pointed out, The Companys acquisition of the Cell-in-a-Box approach along with the expertise of SG Austria could significantly advance the implementation and utilization of stem cells for a host of debilitating diseases and conditions, in addition to being used to target cancer cells, thus making it a uniquely valuable commodity. We believe that by partnering with leading players in the field, Nuvilex could find that companies with deep pockets would be happy to collaborate or license the delivery system and engage in further research which could result in meaningful development and licensing revenue.

Dr. Robert Ryan, Chief Executive Officer of Nuvilex, added, There is a broad range of expanding research supporting the use of stem cells to treat a variety of human diseases and conditions. Our technology allows for precise maintenance and localization of stem cells, preventing their loss from the critical area of need, that will enable us to potentially create miniature organs at specific sites and as a result we believe greater utilization of those stem cells at the site for their intended purpose, once implanted. As stem cell treatments advance, we expect Nuvilex to be at the forefront of developing new, significant, life changing therapies.

For a detailed review of the research report and valuation methodology, investors are directed to the Goldman Research Report.

About Nuvilex

Nuvilex, Inc. (OTCQB:NVLX) is an emerging international biotechnology provider of clinically useful therapeutic live encapsulated cells and services for encapsulating live cells for the research and medical communities. Through our effort, all aspects of our corporate activities alone, and especially in concert with SG Austria, are rapidly moving toward completion, including closing our agreement. One of our planned offerings will include cancer treatments using the companys industry-leading live-cell encapsulation technology.

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Nuvilex Announces Major Breakthrough in Stem Cell Research

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Texas family turned to Bonita stem cell doctor, but 5-year-old died before 'miracle'

Jason Bell

BONITA SPRINGS Jimmy and Jennifer Bell were scrambling to save their 5-year-old-son, Jason, last fall.

Shell-shocked with a diagnosis that their youngest child had primary pulmonary hypertension, a rare lung disorder, they decided to take a chance. If not, a heart-lung transplant would be their son's only chance.

They put their trust in a Southwest Florida cardiologist, Dr. Zannos Grekos, more than 1,000 miles from their Texas home. They learned Grekos performs an experimental stem cell therapy that possibly could help. That's despite a lack of clinical studies and scientific papers.

The U.S. Food and Drug Administration hasn't approved stem cell therapy despite a buzz of optimism of its potential for repairing damaged tissue.

"I was willing to do anything to give my son a fighting chance," said Jimmy Bell, 43, who owns a landscaping company in Keller, a suburb of Fort Worth. "When you are given no other option, you've got to try something."

The treatment would involve a trip to Bonita Springs where Grekos has his practice, Regenocyte; a trip to the Dominican Republic where the treatment would be done, and an up-front payment of $57,000.

"They looked at his medical records first. They didn't know if they could treat him," Bell said. "Once they agreed to treat him, I talked to Grekos. It was the greatest news in my life. I broke down. I just knew this was going to be the miracle to save his life."

* * * * *

The family wired the money in late October 2011 to a Regenocyte account in the Dominican Republic, according to a copy of the paid invoice furnished to the Daily News.

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Texas family turned to Bonita stem cell doctor, but 5-year-old died before 'miracle'

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

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

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It's not pulp fiction

Stem cell therapy is poised to become the next big thing in the treatment of major diseases. Even those extracted from dental pulp can be preserved for future use

Watching his five-year-old pull at his loose tooth, dad Shekar remembered something he had read in a dental clinic. Stem cells from teeth, called dental pulp stem cells (DPSCs) could be preserved and retrieved to treat his son if he had a major ailment in future. Stemade, a private company, would arrange to collect DPSCs through its Smile Clinics and store them in state-of-the-art labs in several cities across the country. His thought: Stem cell technology is the next big step in medical treatment. Banking SCs is medical bio-insurance for his kid.

Stem cell therapy didn't jump out of a box yesterday. We've heard of it being used in treating leukaemia. Patients with spinal cord injury have spent huge sums on it hoping to get up and walk. Some ask: If a house lizard can grow back its tail, why can't we get our systems to re-start with a million multiplying stem cells?

Kinds of cells

The best cells for banking are embryonic cells which are programmed to develop and grow. But harvesting these is banned. Ethical issues, you know. Adult SCs beyond the embryonic stage are classified as haematopoietic (from umbilical cord blood and bone marrow) and mesenchymal (tissues and organs). While haematopoietic cells are used in the treatment of blood-related diseases such as haemophilia, blood cancer and skin troubles, tissue cells are tried on all problems other than these. HSCs are collected only from the umbilical cord and bone marrow. Tissue cells are taken from many body sources such as bone marrow, placenta, menstrual blood, cornea, outer layer of the heart, liposuction waste and teeth pulp.

Among these DPSCs are perhaps the best option, says Shailesh Gadre, MD, Stemade Biotech. We all lose our milk teeth and cell extraction here is almost painless. As for the permanent teeth, we can harvest the pulp when people have to lose them for orthodontic (cosmetic) reasons, as when braces are fixed or teeth are extracted because of poor positioning. Of course, they need to be free of caries and other dental infections.

But as we age, our cells age too, so DPSCs are best extracted and preserved when we're very young, when the cells are virile and robust. DPSCs have extraordinary doubling properties that give them a huge advantage over other stem cells, says Dr. Julian Deepak, Medical Advisor, Stemade. They are derived from the same source as nerve cells, with the same capacity as neuron cells, making them a better option for treating Parkinson's, Alzheimer's and muscular dystrophy. Work is on to see their effectiveness in curing diabetes.

Back to the kid's tooth. After the dad's call, a dentist from Stemade will check if Milan's tooth is free of disease. At a Smile Clinic he will extract it and take a blood sample. The dentist will then place the tooth in a specially-designed vial of antibiotic solution. The vial will be packed in ice-gel to keep the temperature low during transport. At their lab (which I visited) in suburban Chennai, a visual inspection is done, the tooth is flooded with anti-bacterial solution and broken open. The pulp is extracted, divided into parts for quality control and sterility (aerobic/anaerobic) tests. The processing is done in zero-contamination conditions and the cells are put in 5 different vials and placed in the vapour phase of liquid nitrogen for cryo-preservation. It is complete, patented technology. The cells are stored in raw format and can be retrieved when needed. Shekar gets a certificate and a CR Management number which will be part of his son's medical records.

These are your own (autologous) cells and will need no matching should you need them for treatment of tissue-and-organ-related diseases such as spinal cord/bone/liver/cartilage regeneration, diabetes, eye-care, etc., says Shailesh. Adds Dr. Julian, Now for most diseases we just do maintenance therapy. With their regenerative property, stem cells will cure diseases in the future.

Fine, but for a few details. One, is the banking fee? Yes, you have to pay for the banking facility, but we can help you with EMIs, says Shailesh. Subsidies are given to the poor as part of CSR. We want to reach as many households as possible. Others are the right to will it and fool-proof identification of the cells. We may store DPSCs at six and may need them at sixty.

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It's not pulp fiction

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Stem-cell pawns

To read Hard Cell by Mayrav Saar (PostScript, Feb. 26), one would think the only form of stem-cell therapy is the embryo-destroying kind. There wasnt a single mention of non-embryonic adult stem cells.

One attraction of embryonic versus non-embryonic research for some is political the chance to stick it to pro-lifers. But it grieves me to see ailing people used as pawns in this culture war and being denied the possible benefits of adult stem-cell research.

Flushing such an idea down the memory hole, as you help do with this article, is against the spirit of scientific inquiry.

Bob Hunt, Hillsborough, NJ

Wrong on the right

If social conservatives had won out in history, women would not be able to vote and we would still have slavery (Why Social Issues Matter, Jeffrey Bell, PostScript, Feb. 26).

Their thinking denigrates the role of science and promotes antiquated religious beliefs. Many of the causes taken up by social conservatives have been seen to be wrong in light of later progressive thought.

While social conservatives say some good things, history has shown that their views work against American freedoms an obscurantism that continues today.

Jeffrey Bell should balance his thought with facts and not be led blindly by evangelicals.

Eduardo Rodriguez, Corona

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Stem-cell pawns

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Conflict of Interest: California Stem Cell Agency Releases More Documents in Sladek Violation


The California stem cell agency today released its letter to leaders of the California legislature concerning the conflict of interest violation by the scientist who was then chairman of the panel that makes the de facto decisions on hundreds of millions of dollars in research grants.

The agency also posted the review summary of the application involved in the conflict of interest, which had been missing from its web site.

The incident occurred last April, but was not publicly disclosed by the $3 billion research enterprise until questions were raised this month by the California Stem Cell Report. The case involved John Sladek of the University of Colorado in Denver, then chairman of the CIRM grant review group, which makes decisions on the hundreds of grant applications. The CIRM board of directors has final approval but it almost never overturns a favorable recommendation from the grant panel.

Sladek resigned from the review group after CIRM staff discovered the conflict following the March 17 review session. CIRM called it a "technical violation."

The information provided today by CIRM added some details to the matter, including Sladek's statement that the conflict was inadvertent on his part.

The June 15 letter to the speaker of the state Assembly and the leader of the state Senate was labelled "confidential disclosure." Signed by then CIRM Chairman Robert Klein, it said,

"While preparing the public summary for Basic Biology III Awards Application No. RB3-02119, CIRM staff discovered that Dr. Sladek had co-authored two papers in the last three years with a researcher on the application. Although the researcher’s name was included on the CIRM conflict of interest form, Dr. Sladek did not disclose these publications to CIRM."

As reported earlier, Sladek's participation did not affect the outcome on the application, which was not recommended for funding.

As is CIRM's practice, the review summary of the grant application did not identify the scientist seeking funding. The summary listed one reviewer with an unspecified conflict, Ali Brivanlou of Rockefeller University.

The letter was provided by CIRM at the request of the California Stem Cell Report, which also asked for the review summary of the grant application after discovering it was missing. James Harrison, outside counsel to the agency, said in an email that the summary was not posted because of a "programming error."

The summary can be found here. Here is the letter.Sladek/CIRM Conflict of Interest Letter to California Legislative Leadership

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