Clinical Trials

At RESTEM, we have developed stem cell technologies for the treatment of conditions in the area of regenerative medicine. We apply our stem cell genome technologies to the treatment of neurological, inflammatory, cardiovascular, and autoimmune conditions, that were once considered as irreversible. In recent years, we have advanced several programs and clinical trials to a broad network of collaborations, where we have worked with investigators with some of the leading institutions and scientists across the U.S. and Europe.

Indication Preclinical Investigational New Drug Application (IND) Phase I Phase II
Dermatomyositis / Polymyositis
Duchenne's Muscular Dystrophy
Chronic Kidney Disease
Heart Failure with Left Ventricular Assisted Device
Wound Care and Topicals
1. COVID-19 Identifier: NCT04494386

Restem has partnered with Baptist University in this Phase I clinical trial, where 60 patients with Acute Respiratory Distress Syndrome (ARDS) are dosed with umbilical cord mesenchymal stem cells to determine the possible benefits. ARDS is respiratory failure due to inflammation in the lungs, in this case due to COVID-19. Moving into Phase II, this clinical trial will determine if the stem cell treatments have a positive effect on those suffering from COVID Long Haulers Syndrome. COVID Long Haulers Syndrome is comprised of the long-term effects of COVID-19, including heart inflammation, shortness of breath, fatigue, and brain fog.

2. Dermatomyositis/Polymyositis (DM/PM) Identifier: NCT04723303

Dermatomyositis and polymyositis are autoimmune diseases that affect skin and muscle, causing inflammation and muscle weakness. These autoimmune diseases can ultimately lead to pulmonary fibrosis, or lung scarring that causes difficulty breathing. Restem has partnered with University of Florida in a 9-patient Phase I dose escalating clinical study, which will soon be moving into a larger Phase II study.

3. Duchenne’s Muscular Dystrophy

Restem and University of Florida are preparing to begin Phase I of this clinical trial with children suffering from Duchenne Muscular Dystrophy (DMD). DMD is a type of muscular dystrophy that is fatal and causes muscle weakness in children as young as 4 years old and quickly progresses, causing inability to walk by age 12. This study will determine the effects of stem cell treatment on 12 children suffering from DMD, with hopes to slow the progression of muscle loss.

4. Heart Failure with Left Ventricular Assisted Devices (HF-LVAD)

Restem has partnered with the University of Florida to study patients suffering from gastrointestinal bleeding due to left ventricular assist devices (LVAD). Patients with heart failure are provided with ventricular assist devices to replace the function of a failing heart, however one of the most common and fatal complications is gastrointestinal bleeding. Our nearly complete Phase I trial studies the effects of stem cell treatment on gastrointestinal bleeding due to left ventricular devices.