Strategy

Stemedica conducts extensive pre-clinical and clinical research with partners to generate empirical data on the translational value of stem 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).

The Company’s stem cells are currently being used in pre-clinical and clinical trials for diseases and conditions such as ischemic stroke, myocardial infarction (heart attack), chronic heart failure, cutaneous photoaging (sun damaged skin), traumatic brain injury, spinal cord injury and Alzheimer’s disease.

Clinical Trial Pipeline

Clinical Trial Activities

Based on strong pre-clinical results, Stemedica’s clinical grade lines of adult allogeneic mesenchymal stem cell products are being used in clinical trials and studies for several medical conditions. In the U.S., six Investigational New Drug (INDs) have been approved.

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

Myocardial Infarction

About 725,000 Americans have a heart attack, or an acute myocardial infarction (AMI), every year. One in five AMIs is ‘silent’ where the person is not aware of the damage done to the heart.* CardioCell, a subsidiary of Stemedica, is currently making substantial progress in treatments for myocardial infarction and other cardiovascular conditions.

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, double-blinded, multi-center, randomized study to assess the safety,tolerability, and preliminary efficacy of a single intravenous dose of allogeneic mesenchymal bone marrow cells to subjects with st segment elevation myocardial infarction (STEMI).

*From Center for Disease Control and Prevention’s “Heart Disease: Heart Attack” published August 2015

Chronic Heart Failure

Chronic heart failure (CHF) represents the single largest cause of natural death in the United States. Approximately 5.7 million individuals in the United States suffer from CHF, resulting in more than one million hospitalizations annually. In addition, there is a striking 50-percent mortality rate within five years of diagnosis.* Stemedica’s subsidiary, CardioCell, has completed a Phase I/IIA clinical trial for this indication.

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, single-blind, placebo-controlled, crossover, multi-center, randomized study to assess the safety, tolerability, and preliminary efficacy of a single intravenous dose of ischemia-tolerant allogeneic mesenchymal bone marrow cells to subjects with heart failure of non-ischemic etiology.

*From Center for Disease Control and Prevention’s “Division for Heart Disease and Stroke Prevention: Heart Failure Fact Sheet” published June 2016

Cutaneous Photoaging

Photoaging is a universal condition. Damage from the sun’s rays alters the skin’s underlying structures, such as collagen, elastin, and blood vessels, and contributes to the creation of abnormal epidermal cells, which can become precancerous.*

Curt M. Littler, M.D., F.A.A.D., dermatologist at Sharp Rees-Stealy Medical Group, Inc., is the principal investigator of the study. Dr. Littler commented, “This study is an important step forward in the field of dermatology.” By administering stem cells systemically, this study has the potential to target skin damage throughout the body and promises to pave the way for new treatment approaches for photoaged skin.  Although human cutaneous photoaging isn’t well understood, Stemedica is taking the first, innovative steps towards an efficacious treatment.

Stemedica has initiated a clinical trial to assess the safety, tolerability and clinical effects of Stemedica’s human bone marrow-derived ischemia tolerant mesenchymal cells in subjects with cutaneous photoaging resulting from overexposure to ultraviolet radiation.

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, 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

*From BCC Research’s “Antiaging Products and Services: The Global Market” published August 2013.

Traumatic Brain Injury

In the United States, traumatic brain injury (TBI) is a major cause of disability and death, accounting for approximately 30% of all injury related deaths. Approximately 138 people die from injuries that include TBI every day in the United States. Survivors of TBI often experience lasting effects, from a few days to the rest of their lives, which may include impaired cognitive functions including impaired memory, movement, and other debilitating conditions.* Stemedica is conducting 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 (hMSCs) to Subjects with Moderate Traumatic Brain Injury.

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.

*From Center for Disease Control and Prevention’s “Injury Prevention & Control: Traumatic Brain Injury & Concussion: Get the Facts” published January 2016

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 employs an experienced R&D staff focused on enhancing the properties of our current mesenchymal and neural stem cell products as well as producing new products for use in pre-clinical activities.

Stemedica’s lead R&D product candidates include the allogeneic retinal pigment epithelial (RPE) stem cell line and its proprietary allogeneic human mesenchymal stem cells genetically modified to produce an extra amount of human granulocyte-colony-stimulating factor (hG-CSF).

The factor hG-CSF is known to have multiple physiological effects such as neuroprotection; induction of neurogenesis (the process by which neurons are generated from the neural stem cells and progenitor cells); stimulation of production of anti-inflammatory compounds; stem cell mobilization; and inhibition of apoptosis (programmed cell death). All of these therapeutic effects hold great promise for medical conditions such as inflammatory diseases, ischemic stroke and heart attack. Stemedica’s preclinical in-vivo studies confirmed these therapeutic properties in an animal model.

In addition to Stemedica’s in-house R&D program, Stemedica 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 (non-human use).

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