About the Study
PISCES III is a clinical research study to determine if a study drug, which is made from stem cells, will help improve function in people between 35 and 75 years of age who have limited movement in their arms and/or legs 4–11 months after having an ischemic stroke. Ischemic stroke is the most common type of stroke and occurs when blood flow to the brain is blocked, such as by a clot. This study is open to U.S. participants.
The drug being studied is called CTX0E03 DP. The study drug is made of stem cells and is injected into the brain during surgery. This study will look at how safe the study drug is and how well it works. CTX0E03 DP has been studied previously in 34 people who have had an ischemic stroke.
Patients who meet all of the eligibility criteria and enroll will be placed randomly in one of two groups: One will receive the stem-cell injection into the brain during a surgical procedure; the other group will not receive stem cells during a surgical procedure. You will learn which group you are assigned to once the study has been completed.
All participants will be provided a 12-week physical therapy program and monitored for 12 months. The sponsor will be conducting a second study to follow the long-term progress of everyone in this study.
This study is sponsored by ReNeuron, a leading, clinical-stage cell therapy development company. Their primary objective is the development of novel stem cell therapies targeting areas of significant unmet or poorly met medical need.
ReNeuron has used its unique stem cell technologies to develop cell-based therapies for significant disease conditions where the cells can be readily administered “off-the-shelf” to any eligible patient without the need for additional immunosuppressive drug treatments.
About Duke Clinical Research Institute
Duke Clinical Research Institute (DCRI) is the center coordinating the study on behalf of ReNeuron. The mission of DCRI is to develop and share knowledge that improves the care of patients around the world through innovative clinical research.