Stemedica Medical Team Cautions Patients About Stem Cell Therapy & Comments on PLoS Medicine Article

Stemedica Medical Team Cautions Patients About Stem Cell Therapy & Comments on PLoS Medicine Article

Stemedica provides its observations and comments to the media regarding the PLoS Medicine article published online February 17, 2009. The PLoS Medicine article describes a patient who developed "brain tumors" (glioneuronal neoplasms) after undergoing repeated transplants of "fetal neural stem cells" in Russia starting in 2001.

San Diego, California (PRWEB) February 27, 2009 -- Stemedica Cell Technologies (http://www.stemedica.com), Inc. ("Stemedica") provided its observations and comments to the media regarding the PLoS Medicine article published online February 17, 2009. The PLoS Medicine article describes a patient who developed "brain tumors" (glioneuronal neoplasms) after undergoing repeated transplants of "fetal neural stem cells" in Russia starting in 2001.

"All of us at Stemedica would like to extend our condolences to the young patient involved in this situation and our hope is for a speedy and positive outcome to this unfortunate experience. Never before have we or any of our Principal Investigators ever encountered such an occurrence either in our own research or in any of the published research", said Dr. David Howe, Stemedica's Vice President and Medical Director.

"We want to use this unfortunate incident to warn those seeking stem cell therapy abroad," warns Dr. Nikolai Tankovich, President & Chief Medical Officer of Stemedica, "to make certain that the manufacturer of the stem cells used in transplantation comply with the rigid standards that have been established by the FDA and other Internationally-recognized regulatory agencies. The future of this industry and the safety of all future patients depend on such adherence." FDA Compliance and Surveillance Standards can be referenced by visiting www.fda.gov/cber/compliance.htm (http://www.fda.gov/cber/compliance.htm).

The report in PLoS, Donor-Derived Brain Tumor Following Neural Stem Cell Transplantation in an Ataxia Telangiectasia Patient (http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.1000029), describes the development of multifocal glioneuronal neoplasms along the spinal nerves and brain stem in a 13-year-old patient who underwent repeated transplantation procedures in an attempt to treat ataxia-telangiectasia (A-T). A-T is a progressive neurodegenerative disorder known to have an increased risk of developing cancer.

Malignancy and neoplasia are common in A-T secondary to deficient cellular and humoral immunity. This immune deficiency is a contra-indication to stem cell transplant therapy. In addition, the mutations associated with A-T in the A-T mutation gene lead to mutations in nuclear protein, which normally repairs DNA. This loss of DNA repair combined with immune deficiency in A-T increases risk of neoplasia with and without cellular transplant therapy in A-T.

"Due to age, children and adolescents have significantly increased quantities of growth factors. Adding stem cells, known for their growth factor production capabilities, to a child with this presenting condition may have been a contributing factor. As in the administration of pharmaceuticals, many of which are not recommended for use in children and adolescents in the same way as in treating adults, great care must be taken in using stem cell therapy with this population of patients", said Dr. Michael Bayer, Stemedica's Director of Medical Services.

Based on the facts and references cited within the PLoS Medicine article, researchers have discovered that some of the cells were female and had two copies of the gene that causes A-T. Karyotype testing was reported in this case which confirms inadequate testing of the stem cells prior to transplantation. "The stem cell preparation protocol provided to the parents by the treatment team was reviewed and found to be inadequate by our standards", said Dr. Howe. "No cell characteristics, cell markers or bio-safety data was present. Mechanical desegregation in the 8-12 week age fetus is not recommended. Enzymatic separation is preferred, a process that also removes any dead cells that may be present. There is also a significant lack of detail on the number of cell passages as well as the dispersion of the neurospheres", Dr. Howe went on to say.

Dr. Alex Kharazi, Stemedica's Vice President for Manufacturing & Research observed, "Limited cell culturing in only 12-16 days as described in their protocol is like using a crude primary culture of cells. There are numerous risks associated with using crude cell preparations that have not been subjected to rigid manufacturing and testing protocols such as purity, identity and potency. In addition, the antibiotics used to manufacture the stem cells, are potentially neurotoxic." Dr. Kharazi went on to say, "Overall the description provided for the manufacturing protocol was vague and a poor example of what a well thought out manufacturing and safety-driven process should be. For example, there was no data provided relating to tumorgenicity, toxicity, or bio-distribution testing of the manufactured cells in nude mice which is a mandatory requirement as a first and critical step to assessing cell safety."

"Stemedica is committed to a manufacturing process that puts safety first at all times. Our stem cell product lines go through extensive testing during several stages of the manufacturing process and are also subjected to in-depth pre-clinical studies before filing with the FDA and other regulatory agencies for clinical trials", continued Dr. Kharazi. "Nothing is more important than the welfare of the patient and there is no explanation that can justify any deviance from compliance to FDA guidelines for the manufacturing and testing of stem cells prior to administration. These are the guidelines we follow and any patient considering stem cell therapy, at any location worldwide, should confirm that the manufacturer is in full compliance before they decide to undergo stem cell transplantation." warns Dr. Kharazi.

About Stemedica Technologies, Inc.

Stemedica Cell Technologies Inc. (http://www.stemedica.com (http://www.stemedica.com)) is a specialty biopharmaceutical company that is committed to the development and manufacture of best-in-class adult stem cells for use by approved research institutions and hospitals for pre-clinical and clinical studies. Stemdedica complies with the standards and guidelines established by the FDA and the FDB (Food and Drug Board) in the manufacturing and testing of its stem cells. Within the United States, the Company is currently developing regulatory pathways for stroke, traumatic brain injury and wound repair. Outside the United States, Stemedica provides its adult stem cells to hospitals and research centers that are conducting studies under protocols approved by the appropriate regulatory agencies. These studies are focused on the treatment of neurodegenerative diseases, sight restoration and wound repair. Stemedica is based in San Diego, California.

Media Contact for Stemedica: Dave McGuigan at dmcguigan (at) stemedica.com.

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Contact Information Dave McGuigan

Stemedica Cell Technologies Inc

http://www.stemedica.com

+1 858 658 0910

Stemedica Advances its Certification to Become a Licensed Manufacturer of Adult Stem Cells for U.S. Based Clinical Trials

Stemedica Advances its Certification to Become a Licensed Manufacturer of Adult Stem Cells for U.S. Based Clinical Trials

Stemedica Cell Technologies, Inc. announced today that it has filed with the Food and Drug Branch of the State of California's Department of Public Health for certification as a licensed manufacturer of adult stem cells for U.S.-based Phase I and Phase II Clinical Trials.

San Diego, CA (PRWEB) February 25, 2009 -- Stemedica Cell Technologies (http://www.stemedica.com), Inc. ("Stemedica") announced today that it has filed with the Food and Drug Branch of the State of California's Department of Public Health for certification as a licensed manufacturer of adult stem cells for U.S.-based Phase I and Phase II Clinical Trials. Readiness for manufacture includes obtaining a California Drug Manufacturing License for the Stemedica facility in San Diego, California.

"Completion of this certification will allow us to manufacture stem cells under contract for clinical trials for Stemedica as well as for other companies and research centers in California and across the United States. This marks a significant milestone along the journey toward the future availability of stem cell treatment for patients who so urgently need it," said Dr. Maynard Howe, Vice Chairman and CEO at Stemedica.

To prepare for inspection, Stemedica fully reconstructed its facility according to FDA requirements, which had previously focused on research and development. Stemedica's manufacturing facility now includes a fully compliant manufacturing wing with entry-level gowning rooms, two ISO class 8 sterile gowning suites, an ISO Class 7 Manufacturing Clean Room, an ISO Class 7 Processing Clean Room, a Good Manufacturing Process compliant materials warehouse and a controlled-access Quality Control testing laboratory.

"As soon as Stemedica secures its license from the State of California's Department of Public Health, we plan on filing for one or more IND's (Investigative New Drug) for specific indications with the FDA using our proprietary technology. The final major step by the Food and Drug Branch within the Department of Public Health is an in-depth, in-person inspection by their personnel. We're particularly proud of the fact that we are ready for, and capable of, seeking licensing in California, which has exceptionally stringent standards," said Dr. Alex Kharazi, Vice President, Research & Manufacturing at Stemedica.

"Becoming a Licensed Manufacturer of clinical grade adult stem cells is a significant scientific and medical step forward for the Company," said Dr. Nikolai Tankovich, Stemedica's President and Chief Medical Officer. "Securing this status will allow us to become a primary CMO (Contract Manufacturing Organization) for other for-profit companies and the many research organizations interested in advancing stem cell research through clinical application. Additionally, achieving this regulatory status within the manufacturing world will provide Stemedica with the foundation to advance its own Phase I and Phase II Clinical Studies once approved by the FDA."

About Stemedica Technologies, Inc.

Stemedica Cell Technologies Inc. (www.stemedica.com (http://www.stemedica.com)) is a specialty biopharmaceutical company that is committed to the development and manufacture of best-in-class adult stem cells for use by approved research institutions and hospitals for pre-clinical and clinical studies. Within the United States, the Company is currently developing regulatory pathways for stroke, traumatic brain injury and wound repair. Outside the United States, Stemedica provides its adult stem cells to hospitals and research centers that are conducting studies under protocols approved by the appropriate regulatory agencies. These studies are focused on the treatment of neurodegenerative disease, sight restoration and wound repair. Stemedica is based in San Diego, California.

Media Contact for Stemedica: Dave McGuigan -- dmcguigan (at) stemedica.com.

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Contact Information Dave McGuigan

Stemedica Cell Technologies Inc

http://www.stemedica.com

+1 858 658 0910

Dance Exercise Still The Best Way To Lose Weight Fast & Get In Shape In Tight Economy.

Dance Exercise Still The Best Way To Lose Weight Fast & Get In Shape In Tight Economy.

Many people are abandoning gym memberships and are opting to buy exercise videos to help them lose weight on a budget. Fitness expert Kenn Kihiu says despite latest fitness gimmicks, dance exercise has stood the test of time and is still the best and least expensive way to burn body fat and quickly get in shape while having fun.

Washington, DC (PRWEB) February 24, 2009 -- Exercise videos (http://www.dancexfitness.com) are now the hottest trend as family budgets continue to shrink. Sales are up 65 percent year-on-year according to Tesco. As consumers face cutbacks in the tough economy many are ditching their gym memberships and are now choosing to exercise in the comfort of their homes. Many have realized that exercise videos are cheap, convenient and can be used regardless of the weather.

One of the best selling dance exercise videos (http://www.dancexfitness.com) dominating the market is 'DanceX - Total Body Cardio.' This new exercise video features some of the best dance music from around the globe. It's also fun and very easy to follow even for those with two left feet.

The DanceX (http://www.dancexfitness.com) workout is a much welcomed and needed breath of fresh air in the current hip hop age of complicated exercise videos. The primary reason for the surge in popularity is because DanceX will meet you where are in terms of your talent and fitness ability.

Instead of making dance exercise difficult, it features fun easy to follow dance moves that are mostly low impact. DanceX is part dance, part aerobics and completely fun and not to mention a total body workout. Perfect for those who want to get fit, feel younger and have fun -- while traveling around the globe with some of the hottest music from around the world.

DanceX features the creator Kenn Kihiu a well known consumer health and fitness expert who has a dazzling smile and is choke-full of encouragement, and contagious enthusiasm. When producing this video he opted to use real people and not just fitness models who are 5'7" and 110 lbs. For example one of the background exercisers looks like your average full figured woman in her forties who seems to be having a lot of fun but also fighting to keep up with Kenn.

When it comes to losing weight and getting in shape, Kihiu is a dance exercise (http://www.dancexfitness.com) evangelist because he doesn't know of any other type of workout that can be so effective and yet be so much fun. "Consistency yields results and people will only exercise regularly and more passionately if they are having fun" Kihiu says.

Kenn's new dance exercise videos combine incredible music from around the world (Disco, Latin dance, 50's, Bhangra, Africa, Brazilian Samba, Irish Dance, Classical Music, and Soul Dance) with fun dance exercise moves everyone will love such as The Chicken, Hitch Hike, Disco Rolls, John Travolta Point, Irish Kicks, The Twist, and many others.

During the DVD's 42-minute easy-to-follow dance exercise workout, Kenn well known for his energy and sense of humor calls out the moves in advance so there is no need to memorize them. "The only requirement needed is a heartbeat!" says the charming and motivating Kenn Kihiu.

'DanceX - Everybody's Workout: Total Body Cardio.' Is only available at http://www.dancexfitness.com and retails at $24.95 with free shipping for a limited time. It also features '7 Nutrition Tips for Improving Your Health,' an "8 Minute Abs Workout, a danceX Promo Trailer, a 'Move Your Body, Move Your Life' featurette.

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Contact Information Kenn Kihiu

301-960-4968