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University of California Irvine (UCI) Doses First Patient in Phase IIa Clinical Trial Using Stemedica’s Stem Cells for Alzheimer’s disease

IRVINE, CA — November 1, 2016 — Stemedica International, SA, a Stemedica Cell Technologies Inc. subsidiary that uses its proprietary allogeneic stem-cell therapies for Alzheimer’s disease, announces enrollment of its first patient at the University of California, Irvine (UCI). The study, is entitled A Phase IIa Multicenter, Randomized, Single-blind, Placebo-controlled, Crossover Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Human Mesenchymal Stem Cells in Subjects with Mild to Moderate Dementia Due to Alzheimer’s disease (STEM4AD™).”   

The study will enroll approximately 40 subjects diagnosed with mild to moderate dementia due to Alzheimer’s disease (AD) at least 3 months prior to enrollment, based on the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s disease and Related Disorders Association (NINCDS-ADRDA) Alzheimer’s criteria.  

“Our primary objective for this clinical trial is the evaluation of safety and tolerability of itMSCs in subjects with mild to moderate dementia due to Alzheimer’s disease,” said Lev Verkh, Ph.D. Stemedica’s Chief Regulatory & Clinical Development Officer. He continued “We will also compare treatment and placebo groups for a preliminary efficacy assessment by neurologic, functional, and psychiatric endpoints.” 

 

Stemedica’s bone marrow-derived, allogeneic ischemic-tolerant mesenchymal stem cells (itMSCs) are unique because they are grown under hypoxic conditions that more closely resemble the environment in which they live in the body. Compared to other MSCs, itMSCs secrete higher levels of growth factors usually associated with angiogenesis and healing.  

 

“The Hospital of the University of California, Irvine has one of the nation’s most advanced facilities, and has tremendous resources and expertise that contribute to the validity of our study results,” says Nikolai Tankovich, M.D., Ph.D., Stemedica International’s Executive Chairman. “We hope our unique, hypoxically-grown stem cells will halt or slow down the progression of Alzheimer’s disease and other forms of dementia.” 

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About Stemedica International S.A. 

Stemedica International S.A. is a biotechnology company that develops therapeutic applications for the treatment and prevention of Alzheimer’s disease. The company is a subsidiary of Stemedica Cell Technologies, Inc., a global biotechnology company that manufactures adult allogeneic stem cells. Stemedica International has the worldwide rights to manufacture and distribute its parent company’s allogeneic, ischemia-tolerant mesenchymal stem cell (itMSC) and ischemia-tolerant neural stem cell (itNSC) lines and stem cell factors for Alzheimer’s disease. The company also has Swissmedic licenses to import, export and distribute Stemedica Cell Technologies’ cell lines worldwide for human use in approved clinical trials. Manufactured in compliance with cGMP standards, the stem cell lines have a unique, proprietary technology based on the expansion of cells in constant hypoxia, which provides critical benefits in terms of safety, efficacy and scalability. For more information, visit buy real Proscalpin

 

About Stemedica Cell Technologies Inc. 

Stemedica Cell Technologies Inc. is a global biopharmaceutical company that manufactures best-in-class allogeneic adult stem cells and stem cell factors. The company is a government licensed manufacturer of cGMP, clinical-grade stem cells currently used in US-based clinical trials for acute myocardial infarction, chronic heart failure, cutaneous photoaging, ischemic stroke, Alzheimer’s disease and traumatic brain injury. Stemedica’s products are also used on a worldwide basis by research institutions and hospitals for pre-clinical and clinical (human) trials. Stemedica is currently developing additional clinical trials for other medical indications using adult, allogeneic stems cell under the auspices of the FDA and other international regulatory institutions. The company is headquartered in San Diego, California, and can be found online at buy isotretinoin australia

 

Forward Looking Statements 

This press release may contain forward-looking statements.  Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance and you are cautioned not to place undue reliance on these forward-looking statements.  These statements reflect the views of Stemedica as of the date of this press release with respect to future events and, except as required by law, it undertakes no obligation to update or revise publicly any forward looking statements, whether as a result of new information, future events or otherwise after the date of this press release. 

 

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Stemedica international, S.A.  
David Cheatham, MBA 
Business Manager 
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University of California Irvine (UCI) Doses First Patient in Phase IIa Clinical Trial Using Stemedica’s Stem Cells for Alzheimer’s disease

Lausanne, Switzerland — October 26, 2016 

Stemedica International, SA, a leader in the development of innovative stem cell-based treatments for Alzheimer’s disease (AD), is pleased to announce it will share its latest preclinical data at the Society for Neuroscience 46th Annual Conference held from November 12-16 in San Diego, CA. SfN’s annual meeting is the premier venue for neuroscientists to present emerging science, learn from experts, collaborate with peers and explore new tools and technologies.  

Tristan Bolmont, PhD, Chief Scientist at Stemedica International, will present work entitled “Stem cells treatment for Alzheimer’s disease.”  The research shows that intravenous administration of Stemedica’s mesenchymal stem cells safely decreases aggregation of Abeta and tau hyperphosphorylation, two major neuropathological hallmarks of Alzheimer’s disease. Moreover, the stem cell delivery decreases neuroinflammation and microglia activity in the brain without side effects such as microhemorrhages and cerebral amyloid angiopathy. This research was conducted in conjunction with the École Polytechnique Fédérale de Lausanne (EPFL). In addition to Dr. Bolmont’s presentation, SfN will share a lay language summary with the media as part of Neuroscience 2016’s Hot Topics book and in the Neuroscience 2016 online press room. 

“Stemedica International is excited that more and more scientists and researchers are becoming aware of our groundbreaking research,” says Dr. Nikolai Tankovich, MD, PhD, Stemedica International’s Executive Chairman. “In August 2016, one of the “Hot Line” late-breaking science sessions at the European Society of Cardiology (ESC) featured Stemedica International’s sister company CardioCell’s significant positive results in a Phase IIa chronic heart failure trial using Stemedica’s uniquely potent mesenchymal stem cells. SfN is a great venue for sharing our latest scientific results showing that stem cells may have the potential to benefit Alzheimer’s disease patients.“ 

Stemedica International’s preclinical research on APP/PS1 transgenic mice demonstrate that Alzheimer’s disease pathology is amenable to its proprietary therapeutic stem cell intervention. Stemedica International is the first company in the United States to receive FDA approval for a Phase IIa clinical trial treating Alzheimer’s disease using stem cells.    

Emory University in Atlanta, Georgia and University of California, Irvine are actively recruiting for this important clinical trial. More information including enrollment details, can be found at buy Proscalpin online

 

About Stemedica International S.A. 

Stemedica International S.A. is a biotechnology company that develops therapeutic applications for the treatment and prevention of Alzheimer’s disease. The company is a subsidiary of Stemedica Cell Technologies, Inc., a global biotechnology company that manufactures adult allogeneic stem cells. Stemedica International has the worldwide rights to manufacture and distribute its parent company’s allogeneic, ischemia-tolerant mesenchymal stem cell (itMSC) and ischemia-tolerant neural stem cell (itNSC) lines and stem cell factors for Alzheimer’s disease. The company also has Swissmedic licenses to import, export and distribute Stemedica Cell Technologies’ cell lines worldwide for human use in approved clinical trials. Manufactured in compliance with cGMP standards, the stem cell lines have a unique, proprietary technology based on the expansion of cells in constant hypoxia, which provides critical benefits in terms of safety, efficacy and scalability. For more information, visit buy real Proscalpin

 

About Stemedica Cell Technologies Inc. 

Stemedica Cell Technologies Inc. is a global biopharmaceutical company that manufactures best-in-class allogeneic adult stem cells and stem cell factors. The company is a government licensed manufacturer of cGMP, clinical-grade stem cells currently used in US-based clinical trials for acute myocardial infarction, chronic heart failure, cutaneous photoaging, ischemic stroke, Alzheimer’s disease and traumatic brain injury. Stemedica’s products are also used on a worldwide basis by research institutions and hospitals for pre-clinical and clinical (human) trials. Stemedica is currently developing additional clinical trials for other medical indications using adult, allogeneic stems cell under the auspices of the FDA and other international regulatory institutions. The company is headquartered in San Diego, California, and can be found online at buy isotretinoin australia

 

Forward Looking Statements 

This press release may contain forward-looking statements.  Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance and you are cautioned not to place undue reliance on these forward-looking statements.  These statements reflect the views of Stemedica as of the date of this press release with respect to future events and, except as required by law, it undertakes no obligation to update or revise publicly any forward looking statements, whether as a result of new information, future events or otherwise after the date of this press release. 

 

Media Contact 

Stemedica International, S.A.  
David Cheatham, MBA 
Business Manager 
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STEMEDICA BEGINS FIRST CLINICAL TRIALS IN THE U.S. USING ADULT ALLOGENEIC STEM CELLS TO TREAT ALZHEIMER’S DISEASE

San Diego, California, and Lausanne, Switzerland

Stemedica Cell Technologies, Inc. and its subsidiary, Stemedica International S.A., a leader in the development of innovative stem cell-based treatments for Alzheimer’s disease (AD), are pleased to announce the opening of enrollment into a new study at Emory University in Atlanta and University of California, Irvine (UCI). The study is entitled, “A Phase IIa Multicenter, Randomized, Single-blind, Placebo-controlled, Crossover Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Human Mesenchymal Stem Cells in Subjects with Mild to Moderate Dementia Due to Alzheimer’s Disease.”

The study will enroll approximately 40 subjects diagnosed with mild to moderate dementia due to Alzheimer’s disease (AD) at least 3 months prior to enrollment, based on the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s disease and Related Disorders Association (NINCDS-ADRDA) Alzheimer’s criteria.

“This study is based on exciting preclinical data which demonstrated that intravenous administration of Stemedica stem cells resulted in a delay of accumulation of plaque formation and also in the reduction of plague in an animal Alzheimer’s model. This exciting data has been presented at several international meetings,” says Lev Verkh, PhD, chief regulatory & clinical development officer at Stemedica Cell Technologies. “We are also encouraged by an excellent safety profile of our cells as demonstrated in several ongoing clinical trials conducted by Stemedica and Stemedica affiliates under U.S. Investigational New Drug (IND).”

“As we begin the enrollment process at Emory and UCI, we get closer to reaching our vision for an effective treatment for this devastating disease,” says Nikolai Tankovich, MD, PhD, president and chief medical officer of Stemedica Cell Technologies and executive chairman of Stemedica International.

Ihab Hajjar, MD, associate professor of medicine and neurology at Emory University School of Medicine and an investigator for the Emory Alzheimer’s Disease Research Center, is the Principal Investigator at Emory for this trial. “Since therapeutic options for Alzheimer’s disease are limited, stem cells may offer new ways to manage this illness. This study’s main goal is to demonstrate the safety of using stem cells in AD, and we are pleased to be a site for this Stemedica International trial.”

Aimee Pierce, MD, assistant clinical professor of neurology at UCI and Principal Investigator at UCI for this trial states, “We are constantly looking for new ways to safely treat our patients with Alzheimer’s disease. Our research team looks to build on the prior experience of the phase IIa clinical trial testing allogenic stem cells in ischemic stroke.”

More information about this clinical trial, including enrollment details, can be found at buy Proscalpin online.

About Stemedica Cell Technologies, Inc.

Stemedica Cell Technologies, Inc. is a global biopharmaceutical company that manufactures best-in-class allogeneic adult stem cells and stem cell factors. The company is a government licensed manufacturer of cGMP, clinical-grade stem cells currently used in US-based clinical trials for acute myocardial infarction, chronic heart failure, cutaneous photoaging, ischemic stroke, traumatic brain injury and Alzheimer’s disease. Stemedica’s products are also used on a worldwide basis by research institutions and hospitals for pre-clinical and clinical (human) trials. Stemedica is currently developing additional clinical trials for other medical indications using adult, allogeneic stems cell under the auspices of the FDA and other international regulatory institutions. The company is headquartered in San Diego, California and can be found online at buy Proscalpin online no prescription.

About Stemedica International S.A.

Stemedica International S.A. is a biotechnology company that develops therapeutic applications for the treatment and prevention of Alzheimer’s disease and vascular dementia. The company is a subsidiary of Stemedica Cell Technologies, Inc., a global biotechnology company that manufactures adult allogeneic stem cells. Stemedica International has the worldwide rights to manufacture and distribute the parent company’s allogeneic, ischemia-tolerant mesenchymal stem cell (itMSC) and ischemia-tolerant neural stem cell (itNSC) lines and stem cell factors for Alzheimer’s disease and vascular dementia indications. The company also has Swissmedic licenses to import, export and distribute Stemedica Cell Technologies’ cell lines worldwide for human use in approved clinical trials. Manufactured in compliance with cGMP standards, the stem cell lines have a unique, proprietary technology based on the expansion of cells in constant hypoxia, which provides critical benefits in terms of safety, efficacy and scalability. For more information, visit buying Proscalpin with no rx.

Forward Looking Statements

This press release may contain forward-looking statements. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance and you are cautioned not to place undue reliance on these forward-looking statements. These statements reflect the views of Stemedica as of the date of this press release with respect to future events and, except as required by law, it undertakes no obligation to update or revise publicly any forward looking statements, whether as a result of new information, future events or otherwise after the date of this press release.

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Stemedica International Presents at Geneva Springfield Alzheimer’s Conference in Athens, Greece

Stemedica International, SA, a leader in the development of innovative stem cell-based treatments for Alzheimer’s Disease announced today that its Chief Scientist, Tristan Bolmont, PhD, gave a presentation at the 14th International Athens / Springfield Symposium on Advances in Alzheimer Therapy on Saturday, March 12, 2016 in Athens, Greece. This prestigious symposium drew over 1000 participants from all over the world. Leading scientists discussed new targets and drugs for the treatment of Alzheimer’s disease and novel approaches to current therapy. Dr. Bolmont’s talk was titled, “Stem Cells for Alzheimer’s disease: Translation to Clinical Trials”.

“I was excited to share the latest pre-clinical research and clinical developments that Stemedica International has accomplished in the past year”, says Dr. Bolmont. “Our uniquely potent hypoxically-manufactured mesenchymal stem cells significantly reduce the levels of Abeta amyloidosis in both aged and young transgenic mice along with significant reductions in neuroinflammation. Biodistribution shows that our stem cells penetrate the blood-brain barrier and mechanism of action research indicates that beneficial changes in Abeta and neuroinflammation may be due to increases in certain Abeta degrading enzymes and decreases in certain pro-inflammatory cytokines. Clinically, Stemedica International is the first company in the United States to receive FDA approval for a Phase IIa clinical trial treating AD using stem cells.”

About Stemedica International S.A.

Stemedica International S.A. is a biotechnology company that develops therapeutic applications for the treatment and prevention of Alzheimer’s disease and vascular dementia. The company is a subsidiary of Stemedica Cell Technologies, Inc., a global biotechnology company that manufactures adult allogeneic stem cells. Stemedica International has the worldwide rights to manufacture and distribute the parent company’s allogeneic, ischemia-tolerant mesenchymal stem cell (itMSC) and ischemia-tolerant neural stem cell (itNSC) lines and stem cell factors for Alzheimer’s disease and vascular dementia indications. The company also has Swissmedic licenses to import, export and distribute Stemedica Cell Technologies’ cell lines worldwide for human use in approved clinical trials. Manufactured in compliance with cGMP standards, the stem cell lines have a unique, proprietary technology based on the expansion of cells in constant hypoxia, which provides critical benefits in terms of safety, efficacy and scalability. For more information, visit buying Proscalpin with no rx.

Forward Looking Statements

This press release may contain forward-looking statements.  Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance and you are cautioned not to place undue reliance on these forward-looking statements.  These statements reflect the views of Stemedica as of the date of this press release with respect to future events and, except as required by law, it undertakes no obligation to update or revise publicly any forward looking statements, whether as a result of new information, future events or otherwise after the date of this press release.

Media and Business Contact

David Cheatham

Stemedica International S.A.

+41 (0)78 794 7232

 dcheatham@stemedica.com

 

Stemedica International Receives Approval from Emory University to Initiate Alzheimer’s Disease Study with Adult Allogeneic Stem Cells

Lausanne, Switzerland — February 24, 2016 — Stemedica International, SA, a leader in the development of innovative stem cell-based treatments for Alzheimer’s Disease announced today that it has received IRB approval from Emory University in Atlanta, Georgia to initiate a clinical study entitled, “A Phase IIa Multicenter, Randomized, Single-blind, Placebo-controlled, Crossover Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Human Mesenchymal Stem Cells in Subjects with Mild to Moderate Dementia Due to Alzheimer’s Disease.”This study will enroll approximately 40 subjects diagnosed with mild to moderate dementia at least 3 months prior to enrollment, based on the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) Alzheimer’s criteria.

“We are very excited to take this next step in our clinical plan to develop a treatment for this devastating disease”, says Nikolai Tankovich, M.D., Ph.D., President and Chief Medical Officer of Stemedica Cell Technologies and Executive Chairman for Stemedica International “We will begin treating patients later this year at multiple clinical trial sites.”

About Stemedica International S.A.

Stemedica International S.A. is a biotechnology company that develops therapeutic applications for the treatment and prevention of Alzheimer’s disease and vascular dementia. The company is a subsidiary of Stemedica Cell Technologies, Inc., a global biotechnology company that manufactures adult allogeneic stem cells. Stemedica International has the worldwide rights to manufacture and distribute the parent company’s allogeneic, ischemia-tolerant mesenchymal stem cell (itMSC) and ischemia-tolerant neural stem cell (itNSC) lines and stem cell factors for Alzheimer’s disease and vascular dementia indications. The company also has Swissmedic licenses to import, export and distribute Stemedica Cell Technologies’ cell lines worldwide for human use in approved clinical trials. Manufactured in compliance with cGMP standards, the stem cell lines have a unique, proprietary technology based on the expansion of cells in constant hypoxia, which provides critical benefits in terms of safety, efficacy and scalability. For more information, visit buying Proscalpin with no rx.

Forward Looking Statements

This press release may contain forward-looking statements.  Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance and you are cautioned not to place undue reliance on these forward-looking statements.  These statements reflect the views of Stemedica as of the date of this press release with respect to future events and, except as required by law, it undertakes no obligation to update or revise publicly any forward looking statements, whether as a result of new information, future events or otherwise after the date of this press release.

Media and Business Contact

David Cheatham

Stemedica International S.A.

+41 (0)78 794 7232

 dcheatham@stemedica.com

Stemedica Establishes Stem Cell Commercial Manufacturing Facility

San Diego, California and Epalinges, Switzerland – November 10, 2015 – Stemedica Cell Technologies, Inc., a leading manufacturer of adult, allogeneic stem cells and preserved stem cell proteins, has signed, through its subsidiary Stemedica International SA, an agreement with Smith & Nephew to take over its commercial grade cell manufacturing facility in Lausanne, Switzerland. The facility has been approved by the Swiss Agency for Therapeutic Products (“Swissmedic”), the Swiss equivalent to the U.S. FDA. Stemedica has fully executed the transfer of its proprietary BioSmart Technology Platform™ which allows the company to produce multiple stem cell products for use in the treatment of several medical conditions currently in clinical trials in the United States and internationally.

Through a prior collaboration, Stemedica had initiated a technology transfer to this facility and had completed several engineering runs. This complementary operation will serve to augment Stemedica’s San Diego-based manufacturing facility which is licensed for clinical grade stem cell production. Stemedica plans to begin staffing the Swiss facility immediately and anticipates being fully operational in 2016.

David Cheatham, Stemedica International’s Business Manager, remarked, “Recommissioning an existing, high-quality facility, is a cost-effective, time-efficient solution for Stemedica to support the ever-growing demand for the Company’s unique stem cell products. With plans to add Swiss, European and Asian clinical trial sites, availability of a Phase III and commercial facility to manufacture the Company’s proprietary allogeneic stem cell lines will enable these important trials to move forward quickly and efficiently.”

Nikolai Tankovich, MD, PhD, President and Chief Medical Officer of Stemedica, said, “The addition of the Swiss facility is a major step forward for Stemedica, establishing the Company as a Phase III and commercial manufacturer of multiple lines of stem cell products and preserved stem cell proteins. Stemedica continues to achieve significant milestones as a global leader in stem cell manufacturing.”

“The Swiss facility not only increases Stemedica’s manufacturing capacity for North America and Asia, but it will also allow for the production of European Union-compliant products. This facility enables Stemedica to provide its proprietary stem cell technology to meet the growing needs of its subsidiaries and geographic distribution partners,” added Alex Kharazi, MD, PhD, Chief Technology Officer at Stemedica.

 

About Stemedica Cell Technologies, Inc.

Stemedica Cell Technologies, Inc. is a global biopharmaceutical company that manufactures multiple lines of allogeneic adult stem cells and stem cell factors.  The company is licensed by the State of California, Department of Public Health, Food and Drug Branch to manufacture cGMP, clinical-grade stem cells currently used in U.S.-based clinical trials for chronic heart failure, cutaneous photoaging, ischemic stroke and Alzheimer’s disease.  Stemedica’s products are also used on a worldwide basis by research institutions and hospitals for pre-clinical and clinical (human) trials.  Stemedica is currently developing additional clinical trials for other medical indications using adult, allogeneic stems cell under the auspices of the FDA and other international regulatory institutions.  The company is headquartered in San Diego, California and can be found online at buy isotretinoin australia.

About Stemedica International S.A.

Founded in Epalinges, Switzerland, in 2008, Stemedica International S.A. is a global biotechnology company that develops therapeutic applications for the treatment and prevention of Alzheimer’s disease and vascular dementia. The company is a subsidiary of Stemedica Cell Technologies, Inc., a global biotechnology company that manufactures adult allogeneic stem cells. Stemedica International has an exclusive license to manufacture and distribute the parent company’s allogeneic, ischemia-tolerant mesenchymal stem cell (itMSC) and ischemia-tolerant neural stem cell (itNSC) lines and stem cell factors for Alzheimer’s disease and vascular dementia indications. The company also has Swissmedic licenses to import, export and distribute Stemedica Cell Technologies’ cell lines worldwide for human use in approved clinical trials. Manufactured in compliance with cGMP standards, the stem cell lines have a unique, proprietary technology based on the expansion of cells in constant hypoxia, which provides critical benefits in terms of safety, efficacy and scalability. For more information, visit buying Proscalpin with no rx.

 

Forward Looking Statements

This press release may contain forward-looking statements. Forward-looking statements in this release include statements regarding the manufacture of its Phase III and commercial stem cell products. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance and you are cautioned not to place undue reliance on these forward-looking statements. Risks and uncertainties include, but are not limited to, Stemedica’s ability to staff its Swiss facility and become fully operational within the anticipated time period, or at all; the ability to comply with and meet applicable laws and regulations; and the continued demand for its products. These statements reflect the views of Stemedica as of the date of this press release with respect to future events and, except as required by law, it undertakes no obligation to update or revise publicly any forward looking statements, whether as a result of new information, future events or otherwise after the date of this press release.

Media and Business Contacts:

In the United States

Dave McGuigan

Stemedica Cell Technologies, Inc.

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David Cheatham

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Stemedica International and EPFL Awarded Swiss Government Grant for Diabetes and Stem Cell Research

Epalinges, Switzerland — August 26, 2015 — Stemedica International, a subsidiary of Stemedica Cell Technologies, Inc. (San Diego, CA) and its academic partner, École Polytechnique Fédérale de Lausanne (EPFL) have been awarded a research grant by the Swiss Commission for Technology and Innovation (CTI). The value of the project is CHF 708,000 (approx. 750,000 USD).  Using EPFL’s advanced imaging capabilities, scientists from EPFL and Stemedica International will assess the potential benefits that Stemedica’s ischemic tolerant stem cells and stem cell factors could have for millions of people suffering from Type 1 and Type II Diabetes.

EPFL and Stemedica International recently completed work on a 2012 CTI research grant that showed in pre-clinical studies a dramatic reduction in cerebral Abeta amyloidosis, a major neuropathological hallmark of Alzheimer’s disease.  The spectacular results from this pre-clinical research along with excellent safety data from Stemedica’s Phase I safety study has recently enabled Stemedica International to receive approval from the FDA for a Phase IIa clinical trial in the United States. This trial is expected to start in late 2015.

“We are pleased that we are continuing our collaboration with one of the world’s leading technical academic institutions,” said Nikolai Tankovich, MD, PhD, Executive Chairman of Stemedica International. “We greatly appreciate the support from CTI for this second grant and their belief in Stemedica International and our goal for practical implementation of stem cell technologies. This grant will enable our team to objectively assess the efficacy of our stem cells to potentially restore the vascularization and blood flow in the critical areas of the pancreas that impact the production of insulin.”

EPFL has developed sophisticated imaging methods that allow for both structural and functional in vivo imaging of islets of Langerhans in the pancreas. Within each islet are several types of cells that work together to regulate blood sugar. One cell type is the beta cell. Beta cells sense sugar in the blood and release the necessary amount of insulin to maintain normal blood sugar levels.  The immune system mistakenly sees beta cells as “potential danger” and destroys them, causing type 1 diabetes. The loss of these cells means the body can no longer produce insulin, the hormone required to convert food into energy for the body’s cells.   In this study, a three-dimensional assessment of the islet vascularization and blood flow in non-diabetic and diabetic mouse models will be conducted without the need to inject contrast agents.

Professor Theo Lasser, Head of Laboratoire d’Optique Biomedicale (LOB), EPFL, commented, “We are excited to collaborate again with Stemedica International and to apply our methods of Optical Coherent Microscopy developed at LOB, EPFL and to potentially contribute significantly to finding a cure for diabetes.”

Tristan Bolmont, PhD, Stemedica International’s Chief Scientist commented on the scope of the project, “The scale of this project will allow us to make the correlations that are critical to understanding the potential benefits our stem cells may have for treating or even preventing diabetes.”

 

About Stemedica International S.A.

Founded in Epalinges, Switzerland, in 2008, Stemedica International S.A. is a biotechnology company that develops therapeutic applications for the treatment and prevention of Alzheimer’s disease, vascular dementia and Diabetes. The company is a subsidiary of Stemedica Cell Technologies, Inc., a global biotechnology company that manufactures adult allogeneic stem cells. Stemedica International has an exclusive license to manufacture and distribute the parent company’s allogeneic, ischemia-tolerant mesenchymal stem cell (itMSC) and ischemia-tolerant neural stem cell (itNSC) lines and stem cell factors for Alzheimer’s disease and vascular dementia indications. The company also has Swissmedic licenses to import, export and distribute Stemedica Cell Technologies’ cell lines worldwide for human use in approved clinical trials. Manufactured in compliance with cGMP standards, the stem cell lines have a unique, proprietary technology based on the expansion of cells in constant hypoxia, which provides critical benefits in terms of safety, efficacy and scalability. For more information, visit buying Proscalpin with no rx.

 

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FDA Grants IND Approval for Phase IIa Clinical Trial Using Stemedica’s itMSC Therapy to Treat Alzheimer’s Disease

SAN DIEGO and Epalinges, Switzerland — June 9, 2015 — Stemedica Cell Technologies, Inc. received the FDA’s investigational new drug (IND) approval for a United States-based, Phase IIa clinical study using its allogeneic stem-cell therapy to treat subjects with mild to moderate dementia due to Alzheimer’s disease (AD), the sixth leading cause of death in the United States.   The study is sponsored by Stemedica International, S.A. and will start at the University of California, San Diego (UCSD) under Principle Investigator Douglas Galasko, M.D. and expand to other sites.  Stemedica International will provide management and financial support for this clinical trial.  The clinical trial is titled “A Phase IIa Multicenter, Randomized, Single-blind, Placebo-controlled, Crossover Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Human Mesenchymal Stem Cells in Subjects with Mild to Moderate Dementia Due to Alzheimer’s Disease.”

 “This study was approved based on the excellent safety profile of Stemedica’s cGMP-manufactured, hypoxically-grown stem cells and on solid pre-clinical data obtained by Stemedica International in cooperation with the École Polytechnique Fédérale de Lausanne of Switzerland and with a grant from the Swiss government,” said Lev Verkh, Ph.D. Stemedica’s Chief Regulatory & Clinical Development Officer. He continued “We are very proud of Stemedica’s clinical program under U.S. INDs for several indications including ischemic stroke, acute myocardial infarction, chronic heart failure, cutaneous photoaging and Alzheimer’s disease.  At the study’s conclusion we will understand if our approach is efficacious versus placebo in subjects with Alzheimer’s-related dementia, as evidenced by neurologic, functional, and psychiatric endpoints.”

 Stemedica’s bone marrow-derived, allogeneic itMSCs are unique because they are grown under hypoxic conditions that more closely resemble the environment in which they live in the body. Compared to other MSCs, itMSCs secrete higher levels of growth factors usually associated with angiogenesis and healing. Stemedica International’s AD stem cell therapies feature itMSCs, neural stem cells (NSCs) and stem cell factors, which are described in Stemedica International’s U.S. Patent application #20140286910.

 Promising results were achieved during a three-year, intensive, pre-clinical research project supported by a grant from the Swiss Commission for Technology and Innovation (CTI). The research was conducted at the Laboratoire d’Optique Biomedicale headed by Professor Theo Lasser at École Polytechnique Fédérale de Lausanne (EPFL) in Switzerland.

 Stemedica International’s pre-clinical research was led by Chief Scientist Tristan Bolmont, Ph.D. To evaluate the impact of an intravenous delivery of human mesenchymal stem cells on amyloid pathology, the well-established APPPS1 transgenic mouse model of Alzheimer’s disease was used.  Intravenous delivery of itMSC safely reduced cerebral Abeta pathology in APPPS1 animals analyzed one week after the last injection. Both aged and young APPPS1 mice exhibited significantly decreased Abeta amyloidosis following the itMSC treatments. Concomitantly, microglial activation was diminished in aged and young itMSC-treated APPPS1 mice. No increase of vascular amyloid or manifestation of microhemorrhages was observed following the repeated intravenous itMSC delivery. Biodistribution analysis revealed that intravenously delivered itMSC migrate to the brain and could be detected in this organ with the highest value at one hour post-delivery, decreasing after one day and subsequently dropping below detection level at one week after the injection.

According to Alzheimer’s Disease International, nearly 44 million people have Alzheimer’s or a related dementia. Alzheimer’s and dementia are most common in Western Europe followed closely by North America. The global cost of Alzheimer’s and dementia is estimated to be $605 billion USD, which is close to 1% of the world’s gross domestic product.

“We are very excited to take this next step in developing a treatment for this devastating disease”, says Nikolai Tankovich, M.D., Ph.D., President and Chief Medical Officer of Stemedica Cell Technologies and Executive Chairman for Stemedica International “Our upcoming Phase IIa clinical trial will enable us to make progress towards determining if our stem cell treatment may be able to halt or slow down the progression of Alzheimer’s disease and other forms of dementia.”

 

About Stemedica Cell Technologies, Inc.

Stemedica Cell Technologies, Inc. is a global biopharmaceutical company that manufactures best-in-class allogeneic adult stem cells and stem cell factors.  The company is a government licensed manufacturer of cGMP, clinical-grade stem cells currently used in US-based clinical trials for acute myocardial infarction, chronic heart failure, cutaneous photoaging, ischemic stroke and Alzheimer’s disease.  Stemedica’s products are also used on a worldwide basis by research institutions and hospitals for pre-clinical and clinical (human) trials.  Stemedica is currently developing additional clinical trials for other medical indications using adult, allogeneic stems cell under the auspices of the FDA and other international regulatory institutions.  The company is headquartered in San Diego, California and can be found online at buy isotretinoin australia.

About Stemedica International S.A.

Founded in Epalinges, Switzerland, in 2008, Stemedica International S.A. is a global biotechnology company that develops therapeutic applications for the treatment and prevention of Alzheimer’s disease and vascular dementia. The company is a subsidiary of Stemedica Cell Technologies, Inc., a global biotechnology company that manufactures adult allogeneic stem cells. Stemedica International has an exclusive license to manufacture and distribute the parent company’s allogeneic, ischemia-tolerant mesenchymal stem cell (itMSC) and ischemia-tolerant neural stem cell (itNSC) lines and stem cell factors for Alzheimer’s disease and vascular dementia indications. The company also has Swissmedic licenses to import, export and distribute Stemedica Cell Technologies’ cell lines worldwide for human use in approved clinical trials. Manufactured in compliance with cGMP standards, the stem cell lines have a unique, proprietary technology based on the expansion of cells in constant hypoxia, which provides critical benefits in terms of safety, efficacy and scalability. For more information, visit buying Proscalpin with no rx.

 

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Ready or Not: Stem Cell Therapies Poised to Enter Trials for Alzheimer’s

AlzforumStem cells have been hailed, and hailed some more, as a breakthrough technology. All the same, they have been slow to make real inroads in the understanding and treatment of Alzheimer’s disease. That is about to change, according to scientists who spoke at “Accelerating the Cure for Alzheimer’s Disease through Regenerative Medicine.” cheap Proscalpin online no prescription