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 Activities

COVID-19 / Acute Respiratory Distress Syndrome (ARDS)

Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. This is a novel (or new) coronavirus that has not previously been seen in humans which has a wide range of symptoms reported with certain patients experiencing shortness of breath or difficulty breathing.

Stemedica is initiating a multisite FDA-approved clinical trial to study the use of mesenchymal stem cells for severe lung injury from COVID-19 or other pneumonia titled A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Intravenous Allogeneic Mesenchymal Stem Cells in patients with Severe Lung Injury due to COVID-19 or Other Infectious Pathogens.

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.

Please click 
A Phase II Study in Patients With Moderate to Severe ARDS Due to COVID-19 
for additional trial information.

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.

Please click
A Phase IIa Study of Allogeneic Human Mesenchymal Stem Cells in Subjects With Mild to Moderate Dementia Due to Alzheimer’s Disease.
for additional trial information.

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

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.

Please click
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.
for additional trial information.

Publication linked to this trial:
Levy ML, Crawford JR, Dib N, Verkh L, Tankovich N, Cramer SC. Phase I/II Study of Safety and Preliminary Efficacy of Intravenous Allogeneic Mesenchymal Stem Cells in Chronic Stroke. Stroke. 2019 Oct;50(10):2835-2841. doi: 10.1161/STROKEAHA.119.026318. Epub 2019 Sep 9.

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