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 6–12 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. and U.S. territory participants only.
The drug being studied is called CTX0E03 DP. The study drug is made of stem cells and is injected directly into the brain during surgery. The study will assess the effectiveness of CTX0E03 DP to change the degree of dependency and disability of study participants from baseline, as well as measure a number of safety parameters. 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 and expected to complete a 12-week physical therapy program and monitored for 12 months. The sponsor will also be conducting a second study which you will be asked to participate in to follow your long-term progress.
If you would like to speak to a study nurse to see if you pre-qualify, please call 1-844-707-8336.
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.