Information
CURRENT NEWS RELEASES
STEMEDICA ANNOUNCES THE APPOINTMENT OF DR. CÉSAR AMESCUA GARCIA AS MEDICAL AND REGULATORY
AFFAIRS DIRECTOR – LATIN AMERICA
(Source: June 24 2010; Stemedica Cell Technologies, Inc.)
Dr. AmesCua will be responsible for liaison with regulatory agencies in Latin America regarding approvals of Stemedica’s stem cell products for use in clinical (human) trials which follow the criteria required by the FDA in the United States.
DR. MAYNARD
HOWE, CEO OF STEMEDICA, THE LEADING ALLOGENEIC ADULT STEM CELL MANUFACTURER, JOINS
USO BOARD OF GOVERNORS
(Source: June 11 2010; Stemedica Cell Technologies, Inc.)
Dr. Maynard A. Howe, CEO and Vice Chairman of Stemedica Cell Technologies Inc. (“Stemedica”), an allogeneic adult stem cell manufacturer, was welcomed as the newest member of the USO Board of Governors during their May Board Meeting held in San Antonio, Texas.
STEMEDICA ANNOUNCES THE APPOINTMENT OF DR. LEV VERKH AS CHIEF REGULATORY AND CLINICAL
DEVELOPMENT OFFICER
(Source: June 1 2010; Stemedica Cell Technologies, Inc.)
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.
FDA
APPROVES STEMEDICA IND APPLICATION FOR ISCHEMIC STROKE CLINICAL TRIAL
(Source: April 20, 2010; Stemedica Cell Technologies, Inc.)
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).
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.
PROMINENT HEALTH CARE EXECUTIVE JOINS STEMEDICA BOARD OF DIRECTORS
(Source: Dec 1 2009; Stemedica Cell Technologies, Inc.)
Anthony M. Marlon, MD was elected to the Stemedica Cell Technologies, Inc. (“Stemedica”) Board of Directors at the Company’s November 20th Board Meeting. Roger J. Howe, PhD, Executive Chairman for Stemedica made the announcement, “We are fortunate to have someone of Dr. Marlon’s experience, expertise and stature joining our Board. He brings first hand experience to our Board as a physician and as a prominent business leader within the health care industry for the past thirty seven years.”
STEMEDICA PRESIDENT INVITED TO LECTURE AT THE UNIVERSITY OF OXFORD
(Source: Nov 12 2009; Stemedica Cell Technologies, Inc.)
Nikolai Tankovich, MD, Ph.D., President and Chief Medical Officer of Stemedica Cell Technologies, Inc. was invited to lecture at a multi-disciplinary seminar at the Centre for Science and Society at Trinity College, a constituent college of the University of Oxford, England. The seminar, which focused on current research and medical applications for stem cells, was attended by more than 300 professors and staff representing all facets of the University.
STEMEDICA COMPLETES MEETING
WITH THE FDA
(Source: October 15, 2009; 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 (Investigative New Drug) to evaluate the safety and efficacy of Stemedica's high potency proprietary allogeneic mesenchymal bone marrow-derived stem cells (adult human) as a treatment for ischemic stroke. Based on a meeting October 13, 2009 with the FDA, Stemedica is planning to file an IND application in the first quarter of 2010.
STEMEDICA’S PRESIDENT DELIVERS KEYNOTE ADDRESS AT SWISS-RUSSIAN FORUM
(Source: September 17, 2009; Stemedica Cell Technologies, Inc.)
Dr. Nikolai Tankovich, President of Stemedica, delivered the keynote speech at the Crossing Visions Summit held in Moscow from September 14th – 16th. His presentation at a forum of top Russian and Swiss political, economic and business leaders featured advances in stem cell technology.
UNITED STATES PATENT AND TRADEMARK OFFICE PUBLISHES STEMEDICA'S PATENT APPLICATION
FOR THE TREATMENT OF DIABETIC RETINOPATHY
(Source: Sep 8 2009; Stemedica Cell Technologies, Inc.)
Stemedica Cell Technologies, Inc. USA, a world leader in stem cell research and manufacturing, has filed a patent application with the United States Patent and Trademark Office ("USPTO") for a proprietary methodology in the treatment for Diabetic Retinopathy. The patent application was published by the USPTO on August 27th of this year. The application is supported by extensive data and results from patients treated within a Clinical Study conducted outside of the United States beginning in January of 2006.
THE JORDANIAN STEM CELL COMPANY ACQUIRES STEM CELL TECHNOLOGY FROM STEMEDICA INTERNATIONAL
S.A.
First Clinical Trail Anticipated To Begin Early 2010
(Source: September 7, 2009; Stemedica Cell Technologies, Inc.)
Stemedica Cell Technologies, Inc., (“Stemedica”), a world leader in stem cell research and manufacturing, announced the signing of an agreement today for its breakthrough stem cell and related technology. The Jordanian Stem Cell Company has signed a five year multi-million dollar agreement to purchase the technology from Stemedica's wholly-owned subsidiary, Stemedica International, S.A. The signing ceremony took place at the European Burns Association Congress in Lausanne, Switzerland.
STEMEDICA ACHIEVES MAJOR MILESTONE - COMPANY RECEIVES LICENSE TO MANUFACTURE CLINICAL
GRADE STEM CELLS
(Source: September 1, 2009; Stemedica Cell Technologies, Inc.)
Stemedica Cell Technologies, Inc., (“Stemedica”), a leader in adult stem cell research and manufacturing, announced today that it has been granted a license by the State of California’s Food & Drug Branch to manufacture stem cells for human clinical trials. This Drug Manufacturing License recognizes Stemedica as being compliant with California law and the applicable provisions of the Code of Federal Regulations.
STEMEDICA SELECTED BY WORLD STEM CELL SUMMIT TO PRESENT SCIENTIFIC DISCOVERIES
(Source: Aug 27 2009; Stemedica Cell Technologies, Inc.)
Stemedica Cell Technologies, Inc., 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.
STEMEDICA REQUESTS
PRE-IND MEETING WITH FDA
(Source: Aug 21 2009; Stemedica Cell Technologies, Inc.)
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.
STEMEDICA DISCOVERS SIGNIFICANT BREAKTHROUGH IN THE USE OF STEM CELLS AND STEM CELL
FACTORS FOR THE TREATMENT OF RETINAL DEGENERATION
(Source: July 1, 2009; Stemedica Cell Technologies, Inc.)
Stemedica announced today it has discovered a significant breakthrough in the use of human stem cells and stem cell factors for the potential treatment of degenerations of the retina and retinal pigmented epithelium. Retinal degenerations include diseases such as Retinitis Pigmentosa, which are hereditary conditions in which abnormalities of the retinal pigmented epithelium (RPE) within the eye lead to progressive vision loss. According to one of the study’s Principle Investigators, Dr. Paul Tornambe, “The results from this pre-clinical experiment are exciting. It allows researchers and clinicians to push the envelope in the quest to use stem cells to modulate diseases like Retinitis Pigmentosa.” There is currently no medical treatment that can completely cure Retinitis Pigmentosa – an eye disease that affects approximately 1,500,000 people on a worldwide basis each year.
STEMEDICA EXPANDS GLOBALLY WITH INTERNATIONAL HEADQUARTERS IN SWITZERLAND
(Source: Apr 9 2009; Stemedica Cell Technologies, Inc.)
Stemedica Cell Technologies, Inc. USA, a leader in adult stem cell research and manufacturing, announced today the expansion of its global presence with the formation of Stemedica International S.A. headquartered in the Biopôle Technology and Business Park located in Epalinges, Switzerland near Lausanne. Biopôle is a state-of-the-art complex dedicated to attracting and supporting the expansion of global leaders in the bioscience and medical technology industries. The complex, adjacent to the University of Lausanne, overlooks beautiful Lake Geneva and the snow capped mountains of Switzerland and France. Owned by the State of Vaud, the City of Lausanne and the Municipality of Epalinges, the complex is operated as an independent corporation headed by a Board of Directors with both the vision and the experience to attract world leaders to this premiere complex.
RENOWNED
STEM CELL RESEARCHER FILES STUDY RESULTS WITH STEMEDICA
(Source: Mar 18 2009; Stemedica Cell Technologies, Inc.)
Stemedica received the results today from a Stemedica-sponsored clinical study conducted by renowned stem cell researcher and clinician Professor Philippe Hernigou, MD, Ph.D. The approved clinical study featured Dr. Hernigou's treatment of non-union bone injuries using autologous stem cells, allogeneic stem cells and comparative traditional treatment therapies.
STEMEDICA ANNOUNCES THE APPOINTMENT OF CARL BULLEN AS DIRECTOR OF MANUFACTURING
(Source: Mar 5 2009; Stemedica Cell Technologies, Inc.)
Stemedica announced today the appointment of Carl Bullen as Director of Manufacturing. Mr. Bullen will be responsible for manufacturing systems and procedures at Stemedica's San Diego-based manufacturing facility that is built to cGMP standards and is currently pending FDB license. Mr. Bullen has extensive experience in all aspects of cell culture manufacturing as well as the commercialization of new biomedical technologies for United States and European markets.
CIRM COMPLETES BRIEFING
VISIT TO STEMEDICA CELL TECHNOLOGIES
(Source: Mar 2 2009; Stemedica Cell Technologies, Inc.)
Leadership of the California Institute for Regenerative Medicine ("CIRM") completed a two part visit to Stemedica Cell Technologies, Inc. ("Stemedica") to tour its manufacturing facility, R&D lab and corporate headquarters.
STEMEDICA MEDICAL TEAM CAUTIONS PATIENTS ABOUT STEM CELL THERAPY & COMMENTS ON PLoS
MEDICINE ARTICLE
(Source: Feb 26 2009; Stemedica Cell Technologies, Inc.)
Stemedica Cell Technologies, Inc. (“Stemedica”) provided its observations and comments to the media regarding the PLoS Medicine article published online February 17, 2009. The PLoS Medicine article describes a patient who developed “brain tumors” (glioneuronal neoplasms) after undergoing repeated transplants of “fetal neural stem cells” in Russia starting in 2001.
STEMEDICA ADVANCES ITS CERTIFICATION TO BECOME A LICENSED MANUFACTURER OF ADULT
STEM CELLS FOR U.S. BASED CLINICAL TRIALS
(Source: Feb 25 2009; Stemedica Cell Technologies, Inc.)
Stemedica announced today it has filed with the Food and Drug Branch of the State of California's Department of Public Health for certification as a licensed manufacturer of adult stem cells for US based Phase I / Phase II Clinical Trials
DR. RICCARDO NISATO APPOINTED DIRECTOR OF MANUFACTURING AND CLINICAL BUSINESS DEVELOPMENT
OF STEMEDICA INTERNATIONAL
(Source: Feb 13 2009; Stemedica Cell Technologies, Inc.)
Stemedica Cell Technologies, Inc. announces today that it has appointed Riccardo Nisato, MBA, PhD, as Director of Manufacturing and Clinical Business Development of Stemedica International, CH. Dr. Nisato will be responsible for replicating Stemedica's U.S. based operations to Stemedica's International's center based in Lausanne, Switzerland.
STEMEDICA ANNOUNCES THE APPOINTMENT OF DR. MICHAEL BAYER AS DIRECTOR, MEDICAL SERVICES
(Source: Jan 30 2009; Stemedica Cell Technologies, Inc.)
San Diego, CA -- Stemedica Cell Technologies, Inc., a leader in adult stem cell production, announced today the appointment of Michael Bayer, MD, as Director, Medical Services. Dr. Bayer will be responsible for developing pre-clinical and clinical trial protocols for use by research centers conducting pre-clinical and clinical trials using Stemedica products
DR. NABIL DIB TAKES ON SPECIAL ADVISOR TO ROLE TO THE STEMEDICA BOARD OF DIRECTORS
(Source: Jan 26 2009; Stemedica Cell Technologies, Inc.)
Stemedica Cell Technologies, Inc. announces leading stem cell specialist Dr Nabil Dib, MD as Special Advisor to its Board of Directors. Dr Dib is President of the International Society for Cardiovascular Translational Research (ISCTR) and Director of Cardiovascular and Stem Cell Consultants (CSCC).
STEMEDICA CELL TECHNOLOGIES
& GYEONGGI PROVINCE, KOREA JOIN FORCES
(Source: June 2008; Stemedica Cell Technologies, Inc.)
Leaders from Stemedica Cell Technologies and the Gyeonggi Province, Republic of Korea's government, gathered in Palo Alto to sign a comprehensive Memorandum of Understanding that will stimulate economic development and technological advancement between the parties.
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