TOLEDO, OHIO – April/May 2020 – 8 patients with COVID-19-related severe lung injury and ARDS were treated under Investigational New Drug (IND) approval from U.S. Food and Drug Administration (FDA) at the ProMedica hospitals. All patients had reduction in inflammatory markers and improvement in respiratory status. 5 patient recovered fully and went home. 3 died due to severity of disease and co-morbidities.
SANTA MONICA – April 20, 2020 – A single patient, emergency Investigational New Drug (IND) use was cleared by the U.S. Food and Drug Administration for the treatment of severe lung injury due to COVID-19 at the Providence Saint John’s Health Center, Santa Monica, CA.
SANTA MONICA – June 2020 – Expanded use IND for 6 patients was approved by the U.S. FDA for the treatment of COVID-19-related severe lung injury and ARDS. 4 patients were treated and all are showing improvement in respiratory status and inflammatory markers at the Providence Saint John’s Health Center, Santa Monica, CA.
San Francisco, CA – CONGRESS OF NEUROLOGICAL SURGEONS October 19, 2019 – October 23, 2019 – Study sponsor Stemedica Cell Technologies, Inc., a global biotechnology company that uses cGMP manufactured, ischemia-tolerant (itMSCs), bone marrow derived, allogeneic…
Study Sponsored by Stemedica Cell Technologies, Inc. SAN DIEGO, Calif. – (September 30, 2019) – Results from a study sponsored by Stemedica Cell Technologies, Inc., a global biotechnology company that uses allogeneic stem cells for ischemic conditions, form the basis…
Abstract Background and Purpose Stroke is a leading cause of long-term disability. Limited treatment options exist for patients with chronic stroke and substantial functional deficits. The current study examined safety and preliminary efficacy estimates of intravenous…
Stemedica Cell Technologies Reports Positive Data in Phase I/IIa Study of Allogeneic Stem Cells for Ischemic Stroke – itMSCs were safe and well tolerated in the study – – Results of the study are supportive of advancing clinical program – – Plans are underway to…
New Stem Cell Therapy May Transform Heart Failure Treatment
Washington, D.C., April 18, 2018 – Clinical trial planning is underway at MedStar Heart & Vascular Institute to determine whether a novel stem cell therapy will improve heart function for patients with heart failure. MedStar Heart, in partnership with CardioCell,…
August 04, 2017 Kazakhstan Ministry of Health approves Stemedica Mesenchymal Stem Cells (hMSC) as new drug for Acute Myocardial Infarction (AMI).
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…
FDA Grants IND Approval To Stemedica For A Traumatic Brain Injury Phase IIa Clinical Trial
May 18, 2016
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).
Jan 27, 2016
Stemedica 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.”
Stemedica Establishes Stem Cell Commercial Manufacturing Facility
Nov 10, 2015
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…
July 14, 2015: Stemedica awarded U.S. patent for transgenic therapeutic stem cells.
June 9, 2015: Stemedica FDA grants IND approval for phase IIa clinical trial using Stemedica’s itMSC therapy to treat Alzheimer’s disease at the University of California, San Diego (UCSD) under principle investigator Douglas Galasko, MD.
March 24, 2015: Stemedica obtains an exclusive worldwide license for stem cell stabilization and preservation technologies.
October 1, 2014: Stemedica issued U.S. patent for composition of stem cells and stem cell factors for their use and manufacture.
August 12, 2014: SanoStem Fiji grants approval for dual cell hMSC and hNSC clinical trial for ischemic stroke in Fiji to SanoStem Global. SanoStem is working on formal FDA approval also before recruiting patients.
April 8, 2014): Stemedica appoints founding director for NIH center for regenerative medicine to its scientific and medical advisory board. Mahendra Rao, MD, PhD, (Mumbai, India) is a researcher known for his work involving human embryonic stem cells and other somatic stem cells. In 2011, Rao was founding director of the national institutes of health (NIH) center for regenerative medicine.
Feb 27, 2014: India DCGI grants 3 patient import licenses to SanoStem for Personal Use in India with use of Stemedica SanoMSC and SanoNSC.
April 30, 2013: Stemedica issued U.S. patent for ectodermal stem cells.