Archive for August, 2009

Stemedica Selected by World Stem Cell Summit to Present Scientific Discoveries

August 27, 2009

Stemedica Cell Technologies, Inc., (“Stemedica”), a world leader in stem cell research and manufacturing (a licensed manufacturer of clinical grade biological products as licensed by the State of California Food and Drug Branch) continues to advance the stem cell industry with the presentation of two of its latest scientific discoveries at the 2009 World Stem Cell Summit. “We are honored to have the work of our scientific research team selected for presentation at this year’s Summit. This work is expected to increase the efficacy and significantly reduce the time and cost in bringing important research from the bench top to clinical application,” said Nikolai Tankovich, MD, PhD, Stemedica’s President and Chief Medical Officer.

Drs Ludmila Kharazi, MD, PhD and Chih-Min Lin, PhD

From left – Drs Ludmila Kharazi, MD, PhD and Chih-Min Lin, PhD
Originally uploaded by Stemedica

The first discovery accepted by the Summit’s Peer Review Committee was submitted by Chih-Min Lin, PhD, a Stemedica Senior Research Scientist. His submittal is entitled, “Chicken Embryonic Brain: A Model for Testing Neural Stem Cell Potency”. This Neural Stem Cell Evaluation Model determines the potency of neural stem cells and quickly assesses their ability to migrate and engraft inside the developing brain. Stemedica’s technology allows neural precursors to be distinguished at various stages of their maturation, providing timely and cost effective verification of neural stem cell potency in vivo.

“The currently used process for assessing the in vivo potency of neural stem cells in newborn mice is extremely time consuming and expensive. This traditional process also involves the use and sacrifice of animals in facilities separate from manufacturing. Stemedica’s discovery and patent pending technology eliminates the need for animals and replaces this arduous process with a significantly more effective and efficacious model. This model can be deployed within laboratory environment and the evaluation results can be attained in less than two weeks instead of the two to four months using traditional animal testing models,” said Alex Kharazi, MD, PhD, Stemedica’s Vice President of Research and Manufacturing.

Image shows - Neural stem cell migration from the brain ventricle through brain tissue

Neural stem cell migration from the brain ventricle through brain tissue
Originally uploaded by Stemedica

The second finding accepted for presentation at the 2009 World Stem Cell Summit was submitted by Ludmila Kharazi, MD, PhD, Stemedica’s Senior Research Scientist. Her submittal is entitled, “Up-Regulation of Wound Healing Associated Proteins in Long-Term Culture of Human Keratinocyte Precursor Cells.” Dr. Kharazi’s work demonstrates that long term cultivation of human keratinocytes in serum free, low-Ca++ media (SFM) leads to the increased expression of genes for wound healing-associated proteins such as fibronectin, metalloproteinase (MMP9, MMP10), and tissue-type plasminogen activator (TPA). The purpose of Dr. Kharazi’s work was to determine how the propagation of human skin keratinocyte precursor cells (KPC) in SFM to clinically significant numbers will affect their ability to produce fibronectin and other wound healing associated proteins.

“Current technology for the treatment of burns, chronic wounds and diabetic ulcers is extremely expensive, time consuming and lacking in efficacy. Dr. Ludmila Kharazi’s finding suggests that using long term cultivated keratinocyte precursor cells may result in reducing the time of healing while lowering the overall treatment cost. As Stemedica continues to make great advancements in products that can treat burns, chronic wounds and diabetic ulcers, Dr. Ludmila Kharazi’s work is pivotal in providing the Company with advancements that will make our products, and ultimately patient treatment results, the best the industry has to offer,” said Dr. Tankovich. This finding compliments Stemedica’s existing proprietary burn and wound care product currently in clinical trials in Switzerland.

The 2009 World Stem Cell Summit is being held in Baltimore, Maryland from September 21st – 23rd. Presented by the Genetics Policy Institute, the 2009 Summit is hosted by Johns Hopkins University and other leadership organizations from within the stem cell industry, bringing together more than 1,200 researchers, clinicians, business leaders, key policy makers, regulators, advocates, and experts in law & ethics from around the world.

Licensing of the Stemedica’s Neural Stem Cell Evaluation Model Intellectual Property is available to a select number of companies. Additionally, Stemedica is prepared to accept a limited number of projects where the Company’s scientific team conducts the neural stem cell potency evaluation.

About Stemedica Cell Technologies, Inc. 
Stemedica Cell Technologies Inc. (www.stemedica.com) is a specialty biopharmaceutical company that is committed to the development and manufacturing of best-in-class adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and human clinical trials. The company is currently developing regulatory pathways for stroke and wound repair. Stemedica is headquartered in San Diego, California.

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies Inc. (www.stemedica.com) is a specialty biopharmaceutical company that is committed to the development and manufacturing of best-in-class adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and human clinical trials. The company is currently developing regulatory pathways for stroke and wound repair. Stemedica is headquartered in San Diego, California.

For more information regarding this Media Release or Stemedica Cell Technologies, contact Dave McGuigan at dmcguigan@stemedica.com.

Stemedica Requests Pre-IND Meeting With FDA

August 21, 2009

Stemedica Cell Technologies, Inc. USA, a leader in adult stem cell research and manufacturing, has requested a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (“FDA”) to discuss a proposed IND to use Stemedica’s proprietary line of allogeneic mesenchymal bone marrow cells (adult human) as a treatment for ischemic stroke.

Stroke is a leading cause of adult impairment, with 20% of stroke survivors requiring institutional care after 3 months and up to 30% severely and permanently disabled. The only approved treatments of acute ischemic stroke involves restoring blood flow to the affected region by using thrombolytics or mechanical devices that physically remove clots. However, the use of thrombolytics (tPA) is limited due to the therapeutic window of < 3-6 hours post onset of stroke symptoms such that only a small fraction of stroke patients receive this therapy.

"Following a stroke, there is little therapy to offer patients to promote recovery other than physical, occupational, and speech therapy," said Nikolai Tankovich, MD, PhD, President & Chief Medical Officer. "Treatment with allogeneic mesenchymal bone marrow cells may offer new hope to patients with chronic neurological or age-related, neurodegenerative diseases."

Allogeneic mesenchymal bone marrow cells are obtained from donors by extracting bone marrow and are expanded at Stemedica's cGMP compliant facility, which is licensed by the California Department of Public Health, Food and Drug Branch. "Stemedica's facility will manufacture clinical grade stem cells as it prepares for FDA approval of an IND to begin clinical trials," said Maynard Howe, PhD, Vice Chairman and CEO of Stemedica.

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies Inc. (www.stemedica.com) is a specialty biopharmaceutical company that is committed to the development and manufacturing of best-in-class adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and human clinical trials. The company is currently developing regulatory pathways for stroke and wound repair. Stemedica is headquartered in San Diego, California.

For more information regarding Stemedica Cell Technologies, Inc. contact Dave McGuigan at dmcguigan (at) stemedica.com.

Media contact:
Dave McGuigan
Stemedica Cell Technologies, Inc.
+1 858 658 0910


Follow

Get every new post delivered to your Inbox.