This phase 2 trial is investigating the effectiveness of brain injections of CTX0E03 stem cells in the treatment of disability after a stroke.
The main outcome to be measured is the response of the disabled part of the body to the treatment.
The details
Patients with stroke, often experience disability such as one side paralysis. The standard treatment for this is physical therapy. However, this does not work as well for every patient. Prior studies with stem cells therapy showed improved response in the treatment of disabilities after a stroke.
This study aims to evaluate the effect of brain injections of stem cells in the treatment of these patients. The main outcomes will be measured by analysing the changes of the disabled part of the body after the treatment.
Who are they looking for?
This trial is recruiting 110 participants with persistent disability 6 to 12 months after stroke. Participants must still have some movement capacity in the arms, and mental capacity to understand verbal commands.
Patients must not have had a hemorrhagic stroke, history of brain disease, or history of cancer in the past 5 years. Patients must also not have had stem cell treatment before. Patients who cannot stop anticoagulant drugs or antispasticity medications for the required period will be excluded.
How will it work
Patients will be randomly assigned to one of two groups. One group will receive surgery and CTX0E03 by brain injection. The other group will receive surgery alone (no treatment). Patients will be followed for 12 months after surgery. All participants will receive daily physical therapy at home for 12 weeks after their surgery. The response of the body to the treatment will be measured.
