~ Stemedica Completes PRE-IND Meeting with the FDA for Ischmic Tolerant Neural Stem Cells (itNSC) ~
(Source: January 24 2012; Stemedica Cell Technologies, Inc.)
Stemedica Cell Technologies, Inc. (Stemedica), a world leader in stem cell research and manufacturing, announced that it completed its pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding a proposed IND (Investigational New Drug) application to evaluate the safety and efficacy of Stemedica's cGMP manufactured ischemic tolerant allogeneic neural stem cells (adult human) for spinal cord injury.
The proposed initial clinical trial will be a Phase I/IIa for safety and dose escalation using ischemic tolerant adult allogeneic itNSCs administered via lumbar puncture to patients with spinal cord injury and paralysis. The proposed trial will take place at medical centers within the United States.
"We appreciate the guidance and help we obtained in our FDA discussions. We are using this information to fine-tune our IND submission," said Lev Verkh, Ph.D., Chief Regulatory & Clinical Development Officer at Stemedica.
Nikolai Tankovich, M.D., Ph.D., Stemedica's President and Chief Medical Officer pointed out the significance of Stemedica's itNSCs and their relevance to the research and translational medicine communities, "Stemedica has been able to achieve a number of breakthroughs in the manufacture of neural stem cells. The first involves differentiation; more than 80 percent of our stem cells differentiate into functional neurons. We have also proven in vivo that our itNSCs not only migrate, but also engraft and then demonstrate action potential. In other words, they are capable of carrying critical electrical signals."
Stemedica's itNSCs are derived from a single tissue source and expanded under environmentally deprived conditions. Expansion under these conditions enables the cells to function more effectively in areas of tissue damage. Using the Company's proprietary expansion techniques, an estimated 150,000 treatment doses of 100 million stem cells per dose can be derived from this single tissue source. Furthermore Stemedica itNSCs undergo only four passages for the final product, eliminating the problems associated with contamination and mutations. In order to achieve adequate number of cells for clinical applications, most companies must complete 10 or more passages. The Company has a filed a patent application for its ischemic tolerant neural stem cells.
Maynard Howe, Ph.D., Chief Executive Officer of Stemedica noted that, "Stemedica is the only company that owns the entire manufacturing process through commercialization for multiple cells, including ischemic tolerant mescenchymal and neural stem cells. We manufacture our cells under government license and set the highest standards for purity, safety, and batch to batch consistency." The itNSCs are manufactured in licensed facilities in San Diego, California and in Lausanne, Switzerland.
The Company's cGMP produced stem cells are available for sale to researchers and hospitals conducting clinical trials.
About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. 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 conducting clinical trials for stroke under US IND using ischemic tolerant mesenchymal (itMSC) stem cells. Regulatory pathways for spinal cord injury, diabetic retinopathy, acute myocardial infarct, acute respiratory distress syndrome and wound repair are also underway. Stemedica is headquartered in San Diego, California.
Media Contact for Stemedica: Dave McGuigan at [email protected]
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