Stemedica


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CURRENT NEWS RELEASES

STEMEDICA BEGINS FIRST CLINICAL TRIALS IN THE U.S. USING ADULT ALLOGENEIC STEM CELLS TO TREAT ALZHEIMER’S DISEASE
Initial Sites Are Emory University and University of California, Irvine

SAN DIEGO, California, and Lausanne, Switzerland — July 27, 2016 — 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."

FDA GRANTS IND APPROVAL TO STEMEDICA FOR A TRAUMATIC BRAIN INJURY PHASE IIA CLINICAL TRIAL
Clinical trial to study the effects of Stemedica’s proprietary mesenchymal stem cells in patients with
traumatic brain injury

 

SAN DIEGO, California - May 18, 2016. Stemedica Cell Technologies, Inc. (Stemedica) received an FDA investigational new drug (IND) approval for a United States-based, Phase IIa clinical study using its ischemic tolerant, adult allogeneic mesenchymal stem-cells (itMSC) to treat subjects with traumatic brain injury (TBI). The study is sponsored by Stemedica with ProMedica Health Care Systems of Toledo, Ohio serving as both the trial site and a co-financial supporter of the trial. The clinical trial is titled "A Phase IIa, Open-Label Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Human Mesenchymal Stem Cells to Subjects with Moderate Traumatic Brain Injury."

UNIQUE COALITION TO LAUNCH HUMAN STEM CELL TRIAL FOR TRAUMATIC BRAIN INJURY
Hockey Legend Gordie Howe and Allies from Sports, Military and Scientific Communities unite for The Gordie Howe Initiative with ProMedica and Stemedica Cell Technologies
 

TOLEDO, Ohio, May 11, 2016 –Toledo-based ProMedica and San Diego-based Stemedica Cell Technologies, Inc. (“Stemedica”), along with the family of hockey legend Gordie Howe, announced plans today to collaborate on research to advance the treatment of traumatic brain injury (TBI).

STEMEDICA CELL TECHNOLOGIES ANNOUNCES COMPLETION OF ENROLLMENT IN PHASE I/IIA CLINICAL TRIAL FOR ISCHEMIC STROKE

San Diego, California, January 27, 2016: Stemedica Cell Technologies, Inc. announced completion of enrollment into “A Phase I/IIa, 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 focused on patients who were at least six months post-stroke with significant functional or neurologic impairment (defined as confined to a wheelchair or required to have home nursing care or assistance with the general activities of daily living). In addition, inclusion criteria specified that patients have no substantial improvement in neurologic or functional deficits for the two months prior to enrollment in the study.

STEMEDICA ESTABLISHES STEM CELL COMMERCIAL MANUFACTURING FACILITY
Stemedica expands manufacturing capacity for Phase III and commercial stem cell products

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.

STEMEDICA AWARDED U.S. PATENT FOR TRANSGENIC THERAPEUTIC STEM CELLS
(Source: August 13; Stemedica Cell Technologies, Inc.)

Stemedica Cell Technologies Inc., a leading manufacturer of adult, allogeneic stem cells and stem cell factors, received United States Patent No. 9080184 entitled “Transgenic Therapeutic Stem Cells and Methods for Their Use and Manufacture.” The patent issued on July 14, 2015.

FDA GRANTS IND APPROVAL FOR PHASE IIA CLINICAL TRIAL USING STEMEDICA’S ITMSC THERAPY TO TREAT ALZHEIMER’S DISEASE
Planned to Launch in the Fourth Quarter 2015 in the United States as the First Alzheimer’s Clinical Trial Using Intravenous Administration of Ischemia-Tolerant Mesenchymal Stem Cells (itMSCs)

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."

STEMEDICA OBTAINS AN EXCLUSIVE WORLDWIDE LICENSE FOR STEM CELL STABILIZATION AND PRESERVATION TECHNOLOGIES
Commercial-scale Preservation Of Therapeutically-active Stem Cell-derived Products For Worldwide Marketplace Opportunities
(Source: March 24 2015; Stemedica Cell Technologies, Inc.)

Stemedica Cell Technologies Inc., (Stemedica), announced today that Universal Stabilization Technologies (UST) has granted to Stemedica subsidiary StemProtein, LLC, an exclusive worldwide license to its technology known as Preservation by Vaporization (PBV) for industrial scale stabilization of stem cells and stem cell derivatives. This license will allow Stemedica and StemProtein to manufacture stem cell-secreted therapeutic proteins in a VitriLife™ state, that remain shelf stable and therapeutically active at ambient temperatures for two or more years.

STEMEDICA SECURES U.S. PATENT TO USE MULTIPLE STEM CELL LINES SIMULTANEOUSLY TO TREAT ISCHEMIC STROKE
(Source: October 1; Stemedica Cell Technologies, Inc.)

Stemedica Cell Technologies, Inc., a leading manufacturer of adult, allogeneic stem cells and stem cell factors, was issued a new patent from the U.S. Patent & Trademark Office (USPTO), US 8,790,638 entitled “Composition of Stem Cells and Stem Cell Factors for Their Use and Manufacture.” This patent covers a method for treating patients with ischemic stroke, and the treatment includes intrathecal administration of hypoxically grown neural stem cells and intravenous administration of hypoxically grown mesenchymal stem cells.

STEMEDICA EARNS U.S. PATENT FOR CELLULAR SCAFFOLD ENHANCED BY STEM CELL FACTORS
(Source: June 9; Stemedica Cell Technologies, Inc.)

Stemedica Cell Technologies Inc., a leading manufacturer of adult, allogeneic stem cells and stem cell factors, received a new patent from the U.S. Patent & Trademark Office, US8709081 entitled “Cellular Scaffold.” This patent, coupled with the US8105380 patent issued in 2012, extends Stemedica’s proprietary technology to therapeutic skin regeneration. The scaffolds are human skin equivalents that can be transplanted to regenerate skin in patients with skin defects, such as burn injuries, or diseases affecting skin, such as diabetic ulcers.

PRESIDENT OF LEADING SOUTH KOREAN BIOPHARMACEUTICAL COMPANY GREEN CROSS HOLDINGS JOINS STEMEDICA’S BOARD OF DIRECTORS
(Source: April 22; San Diego)

Stemedica Cell Technologies Inc., a leading manufacturer of adult, allogeneic stem cells and stem cell factors, welcomes Byung-Geon “BG” Rhee, Ph.D., President of Green Cross Holdings, a South Korean biopharmaceutical company, to its board of directors. Green Cross, whose recent investment closed Stemedica’s Series B funding round, is one of the world’s largest vaccine and plasma product manufacturers, and the company’s influence in Asia, China and the United States spans advanced research and development, biotech manufacturing and product development. Dr. Rhee’s addition to Stemedica’s board supports both companies’ shared vision of moving stem-cell technologies from clinical trials into worldwide medical practice.

STEMEDICA ISSUED U.S. PATENT METHOD FOR IDENTIFYING NEURIPOTENT CELLS
(Source: Feburary 18; Stemedica Cell Technologies, Inc.)

Stemedica Cell Technologies, Inc., a leading manufacturer of adult allogeneic stem cells and stem cell factors, announced today that the Company has been issued Patent No. US 8,642,286 B2 entitled, Methods for Identifying Neuripotent Cells by the United States Patent and Trademark Office.

STEMEDICA ANNOUNCES NEW BOARD MEMBER AND CHAIRMAN OF AUDIT COMMITTEE
(Source: February 12 2014; Stemedica Cell Technologies, Inc.)

Stemedica announced today that Richard Mejia, Jr. has joined the Company’s Board of Directors and will be Chairman of the Company’s Audit Committee effective January 31, 2014.

STEMEDICA ANNOUNCES NEW CHIEF FINANCIAL OFFICER
(Source: January 27 2014; Stemedica Cell Technologies, Inc.)

Stemedica Cell Technologies, Inc. a leader in adult allogeneic stem cell manufacturing, research and development, announced today that Craig W. Carlson has been appointed the Company’s Chief Financial Officer effective March, 2014.

STEMEDICA ADVANCES TO PHASE II STROKE TRIAL WITH LEAD PRODUCT STEMEDYNE-MSC
(Source: July 10 2013; Stemedica Cell Technologies, Inc.)

Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development, announced today the completion of enrollment and treatment of patients in a Phase I study with Stemedica’s lead product Stemedyne-MSC. These specially formulated ischemic adult allogeneic mesenchymal stem cells have been manufactured at Stemedica’s cGMP compliant facility and have been successfully used to treat patients in an ischemic stroke study “A Phase I/II, Multi-Center, Open-Label Study to Assess the Safety, Tolerability and Preliminary Treatment Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects with Ischemic Stroke.”

STEMEDICA ENTERS INTO A GLOBAL DISTRIBUTION AGREEMENT WITH LIFE TECHNOLOGIES
Life Technologies To Distribute Stem Cell Products For Research Use
(Source: June 13 2013; Stemedica Cell Technologies, Inc.)

Stemedica announced today they have entered into a Global Distribution Agreement with Life Technologies Corporation. Under the terms of this agreement, Life Technologies will exclusively offer Stemedica’s ischemic tolerant allogeneic adult mesenchymal stem cells (itMSCs) and neural stem cells (itNSCs) for sale worldwide to research, academic institutions and corporations both in the United States and internationally. Stemedica stem cell lines will be sold under the brand name Gibco® and will be available to purchase for research initiatives beginning Q2, 2013. The label will also carry the name of Stemedica as the manufacturer of the cell lines.