Acute Stroke Clinical Trial
Official title:
A Phase I, Open Label Study to Evaluate the Safety and to Explore the Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Acute Ischemic Stroke
This study is a first-in-human assessment of safety of using umbilical cord mesenchymal stem cells (UCMSCs) in patients with Acute Ischemic Stroke via a combination of intra arterial (IA) and intravenous (IV) stem cell administration. The novelty of the current UMSC01 treatment study is the dual route of administration. Since dual administration of UCMSC via IA and IV had never been conducted in humans, there may be unknown risks to humans not predicted from the preclinical studies. However, the risk to patients in this trial will be minimized by rigorous adherence to the eligibility criteria, use of appropriate dose and concentration of stem cells, standardized techniques of stem cell infusion, and intensive patient monitoring during and after stem cell infusion.
Each year about 700,000 people experience a new or recurrent stroke in the United States.Stroke is a leading cause of death, along with cancer and coronary heart disease, and the most common cause of physical disability in adults. Moreover, stroke causes a greater loss of healthy life years, as measured in disability adjusted life years, than other diseases. This product is a new cell therapy product for treating Stroke and produced by Ever Supreme Bio Technology Co., Ltd in Taiwan. For animal studies, UMSC01 has been demonstrated its effectiveness for acute myocardial infarction (AMI) and stroke. The UMSC01 has been demonstrated its effective effect in the animal models of stroke in the current studies. The acute stroke rats receiving intracerebral UMSC01 transplantation showed significantly improved neurological function compared to vehicle-treated control rats. ;
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