Strategy

Stemedica conducts extensive pre-clinical and clinical research with partners to generate empirical data on the translational value of progenitor cell-based therapies for medical conditions and diseases for which there are currently no effective treatment alternatives. Stemedica has partnerships with international and U.S.-based researchers and clinicians from major universities, leading research institutions, and accredited medical facilities. All studies, pre-clinical and clinical, are conducted under internationally accepted research guidelines, including Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).

Clinical Trial Pipeline

Clinical Trial Activities

Ischemic Stroke

Every year in the United States alone, almost 800,000 people suffer a stroke. Of that number, more than 137,000 will die from a stroke, making it the third highest cause of death in the United States. Eighty-seven percent of all strokes are ischemic, which are caused by blood clots.* Stemedica has completed a Phase I/IIA clinical trial to assess the safety and efficacy  of using adult bone-marrow derived mesenchymal stem cells for ischemic stroke patients.

The clinical trial was conducted at the University of California, San Diego with Michael Levy, M.D. as the principal investigator, at Gilbert Hospital under the leadership of Dr. Nabil Dib, MD and at the University of California Irvine under the leadership of Steven Cramer, MD.

To learn more about the trial, please click on the link below to be redirected to the website of the National Institute of Health’s clinical trial registry.

A Phase I/II, 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.

*From Center for Disease Control and Prevention’s “Stroke: Stroke Facts” published March 2015

Alzheimer’s Disease

In 2016 alone, the United States spent $236 billion fighting Alzheimer’s disease and other forms of dementia. More than five million Americans are currently living with Alzheimer’s disease, and it is the sixth-leading cause of death across all ages in the United States.* Stemedica is conducting 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.

To learn more about the trial, please click on the link below to be redirected to the website of the National Institute of Health’s clinical trial registry.

A Phase IIa Study of Allogeneic Human Mesenchymal Stem Cells in Subjects With Mild to Moderate Dementia Due to Alzheimer’s Disease.

*From Center for Disease Control and Prevention’s “Healthy Aging: Alzheimer’s Disease” published March 2015.

Research and Development

Neurosphere 4

This photo shows neural cells that are growing as a free-floating cluster in a serum-free nutrient medium.

Stemedica has licensed the exclusive, global distribution rights for the ischemic tolerant mesenchymal stem cell (itMSC) and ischemic tolerant neural stem cell (itNSC) products to Life Technologies for research purposes only. In 2014, Life Technologies was acquired by ThermoFisher Scientific. ThermoFisher Scientific now markets the itMSC and itNSC products under its own private label: StemPro® Neural Stem Cells and StemPro® Mesenchymal Stem Cells. All cells sold to ThermoFisher Scientific by Stemedica are produced under cGMP manufacturing standards at Stemedica’s California-licensed facility and are restricted only for pre-clinical purposes.

Please click here for more information on StemPro® Neural Stem Cells and StemPro® Mesenchymal Stem Cells.