Who can participate in this research study?
This study is recruiting approximately 130 adults 35 to 75 years old with ongoing disability stroke. There are additional criteria that are included in the questionnaire on this website and some that are reviewed by the study team at the study center at the first visit. You must meet all criteria to be able to participate.
What is being tested in this study?
The study drug, CTX0E03 DP, is made from stem cells and is injected in the brain during surgery. The study drug and the equipment being used to inject the stem cells are experimental, meaning they have not been approved for use by the U.S. Food and Drug Administration (FDA). They are being studied in PISCES III as a possible treatment to improve movement in arms and legs after a stroke. The study drug has been studied previously in 34 people who have had an ischemic stroke.
Is there a placebo?
If you qualify for the study, you will be randomly assigned to either the study medication or a placebo group. If you are assigned the study medication, you will receive the stem-cell injection into the brain during a surgical procedure; if you are assigned to the placebo group, you will only receive a surgical procedure with no injection. Neither you or the study staff will know your assignment. There is a 66% chance of receiving the investigational procedure, and a 33% chance of receiving a surgical procedure with no injection.
What are stem cells?
Stem cells are cells that can develop into specialized cells or can split to produce more stem cells. In many tissues they act as an internal repair system. The study drug stem cells were made from a single sample of fetal brain tissue that was voluntarily donated to research following a legal termination of pregnancy. These fetal stem cells were genetically modified so that large amounts of stem cells could be produced and tested as a potential therapy for stroke.
How many people will take part?
Approximately 130 subjects will be involved in this study in the United States at approximately 30 centers. See where the study sites are located.
How do I know if I'm eligible?
This study is open to U.S. and U.S. territory participants only. You will first need to complete an online questionnaire that will ask you details about your stroke, including any remaining disabilities you may have. If you are eligible based on the answers you provide, the DCRI will complete a review of your medical records (you will need to complete a medical records release form authorizing the DCRI to receive a copy).
If after the review you are still found to be eligible for the study, an on-site visit will be scheduled at one of the assessment centers. You will need to undergo some tests to ensure you are eligible for the study.
To get started, complete this eligibility questionnaire.
If you would like to speak to a study nurse to see if you pre-qualify, please call 1-844-707-8336.
How long will I be in this study?
Your participation in the study will last a little over one year. You can choose to stop taking part in the study at any time without penalty or loss of any benefits to which you are entitled. During the course of the study you will be asked to participate in a second study to follow your long-term progress.
How many visits are there?
Participation includes up to 11 visits to a study center.
What about my current medications?
Do not discontinue any medication unless you are advised to do so by the study center staff or your primary care physician.
What about compensation?
All costs related to your travel, meals, and any overnight hotel stays will be paid for you and, if necessary, your caregiver. Assistance with travel may be arranged if you need to travel long distances to get to the assessment center or the surgical center.
Do I need health insurance to participate?
No, health insurance is not needed in order to participate.
Where are the study centers located?
The study centers are located in multiple states within the United States. If there is not a site near you open, we can arrange travel for you and, if necessary, your caregiver. You can see active study centers by clicking here.
Why participate in PISCES III?
If you decide to participate, you will be an important part of the research team and have a vital role in advancing medical knowledge and understanding of stroke therapy.
Who is funding this study?
Funding for PISCES III comes from ReNeuron, a leading stem-cell therapy development company based in the United Kingdom. ReNeuron's primary objective is the development of novel stem cell therapies targeting areas of significant unmet or poorly met medical need.
Why was I disqualified?
Research studies are designed in specific ways to test the study medication for safety and effectiveness. One or more of the answers that you provided were outside of the guidelines for this study. This does not mean you will not qualify for different research studies.