SAN DIEGO, CALIFORNIA – February 29, 2016 – StemCutis, LLC, a subsidiary of Stemedica Cell Technologies, Inc., today announced the addition of the Naval Medical Center San Diego (NMCSD) as a second site for the Phase II portion of its clinical trial for subjects with cutaneous photoaging, a skin condition caused by chronic ultraviolet radiation (UVA and UVB) sun exposure. The study is entitled, “A Phase I/II, Open-Label Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects for Cutaneous Photoaging.” [Read more…]
Why Perinatal Stem Cells Are Gaining Momentum
Recently back from the Perinatal Stem Cell Society Conference in Aspen, CO, I am excited to share new coverage of the stem cell market with you. At this event, experts from around the world shared cutting-edge research about perinatal tissues over the course of three days (March 2-4, 2016).
We also have interviews with stem cell executives released below, including an interview with Dr. Jon Rowley, Founder and CEO of RoosterBio, and Dr. Racheli Ofir, VP of Research & Intellectual Property at Pluristem Therapeutics. Enjoy this exclusive new content!
Stemedica 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 Stemedica Cell Technologies, Inc., a subsidiary and 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 three 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 “Patients will be treated at Emory and additional trial sites to be announced.”
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 www.stemedica-intl.com.
About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a specialty biopharmaceutical company that manufactures best-in-class, allogeneic, adult stem cells and stem cell-derived factors. The company is a government-licensed manufacturer of cGMP, clinical-grade stem cells currently used in clinical trials in the United States under FDA Investigational New Drug (IND) approval for chronic heart failure, cutaneous photoaging, ischemic stroke and Alzheimer’s disease. Stemedica’s products are also used by research institutions and hospitals outside of US under the auspices of international regulatory authorities for pre-clinical and clinical (human) trials. Stemedica is developing clinical trials for other indications using its adult, allogeneic stem cells. The company has headquarters in San Diego, California, and can be found online at www.stemedica.com.
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
[email protected]
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Asterias Reports Successful End-of-Phase II FDA Meeting for Immunotherapy in AML
BioTime Subsidiary Asterias Biotherapeutics Reports the Successful End-of-Phase II FDA Meeting for Immunotherapy in Acute Myeloid Leukemia
Provides Direction for Late-Stage Development of AST-VAC1 in Acute Myeloid Leukemia
ALAMEDA, Calif.–(BUSINESS WIRE)–Feb. 24, 2016– BioTime, Inc. (NYSE MKT:BTX), a clinical-stage regenerative medicine company with a focus on pluripotent stem cell technology, today announced that its subsidiary, Asterias Biotherapeutics (“Asterias”), has successfully completed an End-of-Phase II meeting with the U.S. Food and Drug Administration (FDA) for AST-VAC1, its investigational therapy targeting acute myeloid leukemia (AML). [Read more…]
1st Allogeneic Cell Therapy Product Released in Japan by Mesoblast Licensee, JCR Pharmaceuticals
Mesoblast announced that it is launching the first allogeneic cell therapy to ever achieve full approval in Japan, a mesenchymal stem cell (MSC) product TEMCELL® HS Inj. The product will be used for the treatment of acute graft versus host disease (aGVHD), sold through Mesoblast’s Japanese licensee, JCR Pharmaceuticals.
To learn more, read the full press release from Mesoblast below. [Read more…]
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