Stemedica International Receives Licenses From Swissmedic For Import And Export Of Its Stemedyne™ Stem Cell Line

Epalinges, Switzerland (August 14, 2012)

Stemedica International, SA (Epalinges, Switzerland), a wholly owned subsidiary of Stemedica Cell Technologies, Inc. (“Stemedica”), a leader in adult stem cell research and manufacturing, announced today that it has been granted a series of licenses by Swissmedic (the Swiss equivalent of the United States Food and Drug Administration).  These licenses specifically authorize the Company to import and export its Stemedyne™ stem cell products worldwide for human use in approved clinical trials.

Granting of the license by Swissmedic marks the culmination of a two-year inspection process of Stemedica’s United States and Swiss operations. The Swiss government’s rigorous inspection and approval process has included: (1) a comprehensive, in-depth audit of Stemedica’s processes and procedures; (2) the examination of Stemedica’s quality systems; and (3) interviews with facility management and onsite inspections of the facilities.

Stemedica currently produces two lines of ischemia-tolerant adult allogeneic stem cell products. These include Stemedyne™-MSC, bone marrow derived mesenchymal stem cells and Stemedyne™-NSC, neural stem cells. A third product, Stemedyne™ Retinal Pigment Epithelium (RPE) stem cells is currently in development. Stemedica now has full regulatory approval from the Swiss government to provide these cells to countries that can legally import them for the purpose of conducting clinical trials. Stemedica’s immune-privileged stem cells have been approved and are being used in clinical trials in the United States and in multiple countries.

Dr. Nikolai Tankovich, M.D., Ph.D., Chairman of Stemedica International, noted the significance of the Swiss approval, “Swiss safety regulations are among the most stringent in the world. We are pleased to be recognized for the relentless attention we place on creating cells with the highest standards for safety, purity, potency and scalability.”

According to Maynard A. Howe, PhD, CEO and Vice Chairman of Stemedica USA, “The Swiss government’s approval positions Stemedica International as one of only a few companies worldwide with broad-based regulatory compliance.  Our Swissmedic licenses, coupled with the US Food and Drug Administration (FDA) investigational new drug approval for our mesenchymal stem cells, provides assurance to regulators, hospitals, physicians, and patients, that Stemedica products meet the most rigid specifications. ”

Stemedica’s manufacturing process is in full compliance with current good manufacturing processes (cGMP) requirements in that there is full traceability for every batch lot released by the company.

Earlier this year, Stemedica International, along with its academic partner, The École Polytechnique Fédérale de Lausanne (EPFL) was awarded a $620,000 grant by the Swiss Commission for Technology and Innovation to study the use of optical coherence microscopy for functional label free imaging of brain perfusion and size/number of beta-amyloid plaques with Stemedyne™ neural and mesenchymal stem cells in an animal model for Alzheimer’s.

About Stemedica Cell Technologies, Inc.

Stemedica Cell Technologies, Inc. is a specialty bio-pharmaceutical company committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials.  The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trials for ischemic stroke.  Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells.  The Company is headquartered in San Diego, California.  www.stemedica.com

For more information about Stemedica please contact Dave McGuigan at dmcguigan@stemedica.com

Stemedica Stem Cells Approved For Clinical Trials In Mexico For Chronic Heart Failure

(Source: May 29 2012; Stemedica Cell Technologies, Inc.)
Stemedica Cell Technologies, Inc. announced today that its strategic partner in Mexico, Grupo Angeles Health Services, has received approval from Mexico’s regulatory agency, COFEPRIS, for a Phase I/II single-blind randomized clinical trial for chronic heart failure. COFEPRIS is the Mexican equivalent of the United States FDA. The clinical trial, to be conducted at multiple hospital sites throughout Mexico, will utilize Stemedica’s adult allogeneic ischemia tolerant mesenchymal stem cells (itMSC) delivered via intravenous infusion. The trial will involve three safety cohorts at different dosages, followed by a larger group being treated with the maximum safe dosage. The COFEPRIS approval is the second approval for the use of Stemedica’s itMSCs. COFEPRIS approved Stemedica’s itMSCs in 2010 for a clinical trial for ischemic stroke. These two trials are the only allogeneic stem cell studies approved by COFEPRIS.

Grupo Angeles is a Mexican company that is 100% integrated into the national healthcare development effort. The company is comprised of 24 state-of-the-art hospitals totaling more than 2,000 beds and 200 operating rooms. Eleven thousand Groupo Angeles physicians annually treat nearly five million patients a year. Of these, more than two million are seen as in-patients. In just over two decades, Groupo Angeles has radically transformed the practice of private medicine in Mexico and contributed decisively to reform in the country’s health system. Grupo Angeles hospitals conduct an estimated 100 clinical trials annually, primarily with major global pharmaceutical and medical device companies.

“We are pleased that we will be working with the largest and most prestigious private medical institution in Mexico to study Stemedica’s product for this indication. If successful, our stem cells may provide a treatment option for the millions of patients, both in Mexico and internationally, who suffer from this condition,” said Maynard Howe, PhD, CEO of Stemedica Cell Technologies, Inc.

Roberto Simón, MD, CEO of Grupo Angeles Health Services, noted, “We are proud to be the first organization to bring regulatory-approved allogeneic stem cell treatment to the people of Mexico. We envision that this type of treatment may well become a standard for improving cardiac status for chronic heart failure patients and are pleased to be partnering with Stemedica, one of the leading companies in the field of regenerative medicine.”

Nikolai Tankovich, MD, PhD, President and Chief Medical Officer of Stemedica commented, “For the more than five million North Americans who suffer from chronic heart failure, this is an important trial. Our ischemia tolerant mesenchymal stem cells hold the potential to improve ejection fraction—the amount of blood pumped with each heart beat—and therefore, dramatically improve quality of life.”

About Stemedica Cell Technologies, Inc.  http://www.stemedica.com
Stemedica Cell Technologies, Inc. is a specialty bio-pharmaceutical company committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trials for ischemic stroke. Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells. The Company is headquartered in San Diego, California.

Media Contact for Stemedica: Dave McGuigan at dmcguigan@stemedica.com
For more information about Grupo Angeles and the chronic heart failure trial please contact Paulo Yberri at pyberri@angelesehealth.com.

STEMEDICA ISCHEMIC TOLERANT STEM CELLS PRODUCE SIGNIFICANT IMPROVEMENT IN CARDIAC FUNCTION AFTER HEART ATTACK

(Source: April 3 2012; Stemedica Cell Technologies, Inc.)
Transplanted ischemic tolerant mesenchymal stem cells (itMSC) developed by Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development, produced significant improvement in the pumping function of the left ventricle in patients who had experienced a heart attack. The study was presented at the 26th American College of Cardiology (ACC) meeting in Chicago, March 26, 2012 by Daniyar Jumaniyazov, MD, PhD and Nikolai Tankovich, MD, PhD, President and Chief Medical Officer of Stemedica.

Forty five patients who had experienced an acute myocardial infarct underwent reperfusion by stent and after being carefully matched, were divided into a treatment and a control group. The treatment group received intravenous infusion of Stemedica itMSCs on day seven; the control group received normal saline. At the end of three months, those in the treatment group experienced an 11 point improvement in the ejection fraction of the left ventricle (the amount of blood pumped with each heart contraction) in comparison with the control group. This level of improvement restored the treatment group’s ejection fraction to normal levels. In comparison, the control group showed a level of improvement expected with standard of care; however, the ejection fraction remained below normal. In addition, the treatment group had statistically significant improvements in two blood markers of inflammation; levels of C-reactive protein and BNP were lower in the treated group. Patients in the stem cell treatment group also had improvement in quality of life indicators. Magnetic Resonance Imaging (MRI) performed day six and again day 30 in the treatment group showed significant decreases in lesion size. Patients in this study will be followed for one year.

Commenting on the study, Nabil Dib, MD, MSc, FACC, Director, Clinical Cardiovascular Cell Therapy & Associate Professor of Medicine at the University of California, San Diego noted, “Data from this early clinical trial are very promising. If these results continue as patients are followed longer term, and if they can be replicated in a larger clinical trial, then Stemedica’s ischemic tolerant allogeneic mesenchymal stem cells may well play an important role in the treatment of heart disease.”

According to Jackie See, MD, FACC, an interventional cardiologist specializing in stem cell research in Fullerton, California, “These are impressive results and provide a great deal of hope for patients with heart disease. Stents open up the narrowed blood vessels. With the addition of stem cells, we can potentially rescue some of the damaged myocardial cells, promote new blood vessel growth, decrease inflammation, and strengthen the damaged muscle. I can see a day in the near future when intravenous itMSC administration becomes part of the standard of care following an acute myocardial infarct.”

Noting that not all stem cells are created equally, Dr. Tankovich raises a key point about the research, “This study highlights the importance of using allogeneic stem cells specifically manufactured to be effective in the toxic tissue environment following a heart attack. In vitro, we know that our itMSCs secrete more of the important healing factors in response to ischemia. Our cells also retain their ‘steminess,’ remaining undifferentiated and potent throughout the manufacturing process. They also pass the most stringent tests for infectious disease, acute and chronic toxicity and tumorigenecity, and they are immune privileged. These are some of the advantages of using a well characterized, homogeneous population.”

Dr. See notes that the importance of expanding cells from a single, healthy young donor versus using autologous bone marrow cells from the same patient. “Results from a large multi-center study supported by the National Heart, Lung, and Blood Institute, presented at the ACC, showed that bone marrow derived stem cells taken from older, sicker patients were not very effective in improving heart function. This is understandable, because these stem cells no longer have the power to differentiate, migrate, engraft and secrete the factors that are necessary for wound healing. So the patients who most need the treatment do not have potent stem cells to accelerate the cardiac healing process.”

Dr. Tankovich further notes that providing enough stem cells for thousands of patients who could benefit from Stemedica’s itMSC treatment is not an issue. “With our advanced expansion techniques, with only four passages, from a single tissue donation, we can treat half a million patients.”

The placebo controlled blinded Phase II clinical trial was conducted according to ICH guidelines at the National Medical Research Center (NMRC) in Astana, Kazakhstan. The NMRC is Kazakhstan’s premier medical research institute and internationally known for initial assessment and treatment of returning NASA astronauts. Based upon the outcome of this trial, NMRC is planning a Phase III trial using Stemedica’s itMSCs for a larger population.

Stemedica is planning a parallel Phase II clinical trial in the United States and Switzerland. The U.S. based trial will take place under Stemedica’s existing IND for the itMSCs.

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a specialty bio-pharmaceutical company committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trials for ischemic stroke. Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells. The Company is headquartered in San Diego, California.

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

Stemedica Completes Pre-IND Meeting with the FDA for Ischemic 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 dmcguigan@stemedica.com

Stemedica Completed Enrollment In First Cohort Of Patients With Ischemic Stroke Utilizing Allogeneic Mesenchymal Stem Cells

Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development, announced today that its specially formulated ischemic adult allogeneic mesenchymal stem cells have been successfully used to treat the first cohort of patients in an ischemic stroke study conducted at the University of California, San Diego (UCSD). A total of 35 patients will be enrolled in the clinical trial entitled: “A Phase I/II, Multi-Center, Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects with Ischemic Stroke.”

Lev Verkh, PhD, Stemedica’s Chief Regulatory and Clinical Development Officer, commented: “All patients in the first cohort received an initial dose of adult allogeneic stem cells and no product related adverse events were reported. An Independent Data Safety Monitoring Board (DSMB) reviewed the safety data for the subjects including adverse events, laboratory data and vital signs and based on that review, the DSMB unanimously voted for the study to proceed to the next dose.”

The Principle Investigator Michael Levy, MD, PhD, FACS, Chief of Pediatric Neurosurgery at Children’s Hospital San Diego (CHSD) and Professor of Neurological Surgery at the University of California, San Diego (UCSD) commented that “he is pleased with the safety profile demonstrated in this initial phase of the study and is looking forward to completing Cohorts 2 and 3 given the promising results to date.”

Patients in this study have significant functional or neurologic impairment that confines them to a wheelchair or requires home nursing care or assistance with the general activities of daily living and have received the ischemic stroke diagnosis at least six months prior to enrollment in this study.

Information on enrolling in the study can be found at http://clinicaltrials.gov/ct2/results?term=stemedica.

More than 800,000 Americans suffer a stroke annually and according to the American Heart Association, stroke is the fourth leading cause of death – costing an estimated $73.7 billion in 2010 for stroke-related medical costs and disability.

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a specialty bio-pharmaceutical company that is committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trial for ischemic stroke. Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells. The Company is headquartered in San Diego, California.

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

Stem Cell Partnership In Lebanon Announced

BEIRUT, Lebanon (June 20, 2011) Amni BioScience, SAL (“AMNI”) announced today the formal signing of a long-term agreement with Clinique Du Levant Société Médicale SAL (“LEVANT”) in Beirut, Lebanon. This agreement will initiate a wide array of therapies involving the use of adult stem cell products as manufactured by Stemedica Cell Technologies under FDA (United States Federal Drug Administration) approval.

In order to maximize the rapidly expanding research and clinical application opportunities available within the fields of restorative and regenerative medicine, AMNI and LEVANT plan on playing a critical role in the full evolution of the most advanced regenerative-based therapies and services. “We’re honored to be working with a facility with the kind of outstanding leadership as LEVANT”, said Amni BioScience President Mr. Sam Alkhass. “Together, we plan on becoming a world leader in the fields of restorative and regenerative medicine.”

From left to right: Dr. Ziad Salameh, Vice President, Amni BioScience;Dr. Antoine Maalouf, Chairman, Levant Clinique;Mr. Sam Alkhass, President, Amni BioScience;and, Dr. Jean Pierre Saab, Chief Medical Officer, Amni BioScience.

The agreement between AMNI and LEVANT calls for the pro-active implementation of clinical trials using allogeneic adult stem cells as manufactured by Stemedica Cell Technologies, Inc., San Diego, California (“STEMEDICA”) as well as their wholly-owned, Swiss-based subsidiary, Stemedica International. Stemedica is licensed to manufacture allogeneic adult stem cells under cGMP manufacturing practices and is regarded as a world leader in the development and manufacture of allogeneic adult stem cells. “We’re excited about the relationship that our exclusive Middle East Distributor, Amni, has agreed to with LEVANT”, said Dr. Nikolai Tankovich, Chairman of Stemedica International and President, Chief Medical Officer of Stemedica International’s parent firm, Stemedica Cell Technologies, Inc. “We look forward to developing a long and mutually-beneficial working relationship between Stemedica International, which services our Middle East operations, and partnership with LEVANT.”

Stemedica’s product line will be imported into Lebanon by Benta Pharmaceutical, (“BENTA”) the Nation’s leading Pharmaceutical Manufacturing Company. “We’re pleased to be joining Amni BioScience and Stemedica as we work together to bring the regenerative powers of allogeneic adult stem cells to Lebanon and the Middle East”, said Mr. Bernard Tannoury, Chairman of Benta. “Together we will bring the safest and most clinically advanced allogeneic adult stem cells to the region for the betterment of patients and the economy alike.”

Once all importation requirements have been met, Amni BioScience will work closely with the medial leadership of LEVANT to implement a “Clinical Trial to Commercial Pathway” strategy for one or more medical indications. According to AMNI’s Chief Medical Officer, Dr. Jean Pierre SAAB, “We’re working closely with the Ministry of Health in Lebanon, Scientific Societies and Lebanese Order of Physicians, to establish regulatory guidelines that protect patients and create the highest levels of safety and efficacy. We’re committed to helping establish “The Gold Standard” in safety and clinical trial advancements of stem cells here in Lebanon and throughout the Middle East.”

Clinique Du Levant Société Médicale SAL is regarded as one of the most prestigious medical facilities in the Middle East and is recognized for its advanced medical treatment in numerous medical categories. “We’re delighted to be working with Amni BioScience leadership and look forward to building our relationship and service offerings into the regional leader for restorative and regenerative health care. We believe our relationship with the stem cell movement is an excellent addition to the many advanced and basic medical offerings of our facility”, said Dr.Antoine Maalouf, Chairman of LEVANT.

About Amni BioScience SALOur vision is to build Amni into a medical powerhouse in the region through the promotion of the most advanced medical services and technologies available in the Middle East. We are bringing this vision into reality through a comprehensive series of representation, ownership and acquisition positions with a select number of targeted corporate partners and properties.
www.amnibioscience.com

About Clinique Du Levant Société Médicale SALThe mission of Clinique Du Levant Société Médicale is to provide the highest quality of care and service for all people, while preserving quality of life, by attracting and supporting physicians of the highest character and greatest skill. LEVANT provides world class medical care, continual education, through highly specialized physicians, and dedicated staff. LEVANT is located in Beirut, Lebanon.
www.lacliniquedulevant.com

About Stemedica and Stemedica International
Stemedica Cell Technologies is a world leader in the manufacture of allogeneic adult stem cells. The company’s headquarters and primary manufacturing facility is located in San Diego, California. Based in Lausanne, Switzerland, Stemedica International is a wholly-owned subsidiary of 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 preclinical and human clinical trials. Stemedica is headquartered in San Diego, California.
www.stemedica.com

Stemedica Receives Approval From UCSD To Initiate Ischemic Stroke Study With Adult Allogeneic Stem Cells

(Source: February 17 2011; Stemedica Cell Technologies, Inc.)
Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development announced today that it has received IRB approval from the University of California, San Diego (UCSD) to initiate a Stemedica clinical study entitled, “A Phase I/II, Multi-Center, Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Ischemic Stroke”. This study will enroll approximately 35 subjects with a clinical diagnosis of ischemic stroke. These patients have significant functional or neurologic impairment that confines them to a wheelchair or requires home nursing care or assistance with the general activities of daily living and have received the ischemic stroke diagnosis at least six months prior to enrollment in this study.

Michael Levy, MD, PhD, FACS Chief of Pediatric Neurosurgery at Children’s Hospital San Diego (CHSD) and Professor of Neurological Surgery at the University of California, San Diego is the principal investigator of the study. Dr. Levy looks forward to enrolling patients, and reinforces the importance of clinical stem cell research. “This is an important step forward in translational medicine. This study may help pave the way for a new therapeutic category of treatment for ischemic stroke.”

Lev Verkh, PhD, Stemedica’s Chief Regulatory and Clinical Development Officer, commented, “We are pleased and delighted to be working with UCSD and Dr. Levy. We believe that progressing rapidly down the regulatory pathway may eventually provide treatment options for the 800,000 Americans who suffer a stroke each year.” According to the American Heart Association, stroke is the fourth leading cause of death, costing an estimated $73.7 billion in 2010 for stroke-related medical cost and disability.

The safety of stem cell treatment is of paramount concern to all stake holders in this emerging industry. Nikolai Tankovich, MD, PhD, President of Stemedica, highlights the Company’s relentless attention to this area. “As a cGMP government-licensed manufacturer of adult stem cells, we have also received an investigational new drug (IND) approval from the FDA for this clinical trial. Very few companies have this unique dual capacity. Our cells have gone through rigorous testing to make certain they are free from infectious agents and are not tumorigenic.”

Maynard Howe, PhD, Vice Chairman and CEO of Stemedica notes, “The medical and scientific community has much work to do in the prevention and treatment of stroke. Too many patients and family members have to cope with the aftermath of this disease. It is our hope that stem cell treatment may eventually ease the burden faced by patients and caregivers as well as curtail the extensive healthcare and rehabilitation costs.”

Information on enrolling in the study can be found at http://clinicaltrials.gov/ct2/results?term=stemedica.

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies Inc. is a specialty biopharmaceutical company that is committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trials for ischemic stroke. Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells. The Company is headquartered in San Diego, California.

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

Stemedica Announces the Appointment of Dr. Lev Verkh as Chief Regulatory and Clinical Development Officer

Stemedica Cell Technologies, Inc., a leader in adult stem cell research and manufacturing, announced today the appointment of Lev Verkh, PhD as Chief Regulatory and Clinical Development Officer. Dr. Verkh will be responsible for managing all regulatory activities and clinical trials on behalf of the company. “Dr. Verkh brings over twenty years of international regulatory and clinical trial experience to Stemedica,” said Dr. Nikolai Tankovich, Stemedica’s President & Chief Medical Officer. “We are confident that his contribution to our mission to bring innovative products to patients, following FDA guidelines, will be significant.”

Dr Lev Verkh, PhD appointed as Chief Regulatory and Clinical Development Officer.
Originally uploaded by Stemedica

Dr. Verkh’s clinical and regulatory experience includes working for Pfizer, Baxter Bio Sciences, the Alliance Pharmaceutical Corporation and the Alpha Therapeutic Corporation. He has directed national and multi-national Phase I, II, III and IV clinical trials in such areas as cardiology, oncology, peripheral artery disease, hematology, blood disorders and imaging methods. He is author or co-author of over 40 peer-reviewed publications. Through his efforts and the efforts of his teams, he has received FDA approval for several products that are currently on the market. “I am honored to be joining Stemedica’s management team,” said Dr. Verkh, “and am excited to work with the company’s leading-edge stem cell technology.”

In addition to directing Stemedica’s clinical trials within the United States, Dr. Verkh will be assisting foreign regulatory agencies to establish guidelines for stem cell technologies in medicine. He will also assist in organizing and supervising clinical trials outside the United States utilizing Stemedica technology.

“With the rapid advancement of clinical application and development of adult stem cell technologies around the world, the addition of Dr. Verkh is essential to our long-term growth plan”, said Maynard Howe, PhD, Stemedica’s Chief Executive Officer. “Stemedica is working closely with government leaders, scientists and clinicians to establish and promote best scientific practices in the emerging field of stem cell research and therapy.”

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 developing regulatory pathways for stroke, cardiomyopathy, diabetic retinopathy and wound repair. Stemedica is headquartered in San Diego, California.

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

FDA Approves Stemedica IND Application for Ischemic Stroke Clinical Trial

Stemedica Cell Technologies, Inc. (Stemedica), a world leader in stem cell research and manufacturing, announced that the U.S. Food and Drug Administration (FDA) approved its application for an Investigational New Drug (IND) for a clinical trial for ischemic stroke using Stemedica’s high potency proprietary allogeneic stem cells (adult human).

“The FDA acceptance of our IND application and the clinical protocol for usage of allogeneic mesenchymal bone marrow-derived stem cells in subjects with ischemic stroke is an important milestone for Stemedica in its development program,” said Nikolai Tankovich, MD, PhD, Stemedica’s President and Chief Medical Officer. “Currently, patients suffering from ischemic stroke have very limited treatment options. We hope that bringing this novel option to the medical community will help to alleviate the burden of a serious and disabling disease and will be valuable for both patients and their family members.”

The IND application approval allows Stemedica to initiate a planned clinical trial at medical centers within the United States. The clinical trial will be a Phase I/II dose escalation and safety clinical trial using allogeneic mesenchymal bone marrow cells administered intravenously to patients with ischemic stroke. The patient population will include individuals with significant functional or neurologic impairment related to the ischemic stroke that confines the subject to a wheelchair or requires the subject to have home nursing care or assistance with the general activities of daily living.

“This approval, along with the licensing of our cGMP manufacturing facility, are two important breakthroughs in our company’s evolution,” said Maynard Howe, PhD, Stemedica’s Vice Chairman & CEO. “It is a testament to the professionalism and focused persistence of our team.”

Stemedica is licensed by the State of California’s Department of Public Health, Food and Drug Branch to manufacture stem cells, drugs and biologic products for human clinical trials. The Company is compliant with both California law and the Code of Federal Regulations.

About Stemedica Cell Technologies

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 Files IND Application with FDA for Treatment of Stroke with Adult Allogeneic Mesenchymal Stem Cells

(Source: March 19, 2010; Stemedica Cell Technologies, Inc.)

Stemedica Cell Technologies, Inc. (Stemedica), a world leader in stem cell research and manufacturing, announced that it has filed an Investigative New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for a clinical trial. The trial will assess the safety, tolerability and efficacy of Stemedica’s high potency proprietary allogeneic mesenchymal bone marrow-derived stem cells (adult human) as a treatment for ischemic stroke.

The proposed clinical trial will be a Phase I/II dose escalation and safety clinical trial using allogeneic mesenchymal bone marrow cells administered intravenously to patients with ischemic stroke. The patient population will include individuals with significant functional or neurologic impairment related to the ischemic stroke that confines the subject to a wheelchair or requires the subject to have home nursing care or assistance with the general activities of daily living. The proposed trial will take place at medical centers within the United States.

“Stemedica achieved another milestone in its development program by moving from research to patient bedside to help people suffering from stroke,” said Nikolai Tankovich, MD, PhD, Stemedica’s President and Chief Medical Officer. “In addition to the official licensing of our manufacturing facility in San Diego, California, we have now established our own clinical trial pathway in compliance with FDA and FDB regulatory requirements. Stemedica’s goal is to receive regulatory approval of our mesenchymal stem cells for this clinical indication.”

“We are happy that Michael Levy, MD, PhD, Chief of Pediatric Neurosurgery at Rady Children’s Hospital of San Diego and Professor of Surgery at UCSD’s School of Medicine, will be the Principal Investigator leading our clinical trial,” said Maynard A. Howe, PhD, Vice Chairman and CEO, who added “Stemedica is committed to developing, manufacturing and distributing adult stem cells that have the potential to save, restore and improve lives. This mission is central to everything that Stemedica does and we are dedicated to executing this mission with great passion and scientific discipline.”

Stemedica was granted its license by the State of California’s Department of Public Health, Food and Drug Branch to manufacture stem cells for clinical trials in July, 2009. The Drug Manufacturing License grants Stemedica the right to manufacture clinical-grade (for human use) drug or biologic products and recognizes Stemedica as being compliant with California law and the applicable provisions of the Code of Federal Regulations.

About Stemedica Cell Technologies

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.