Brain stem cell transplant aims to restore movement after stroke
NCT ID NCT07709845
First seen Jul 17, 2026 · Last updated Jul 17, 2026
Summary
This phase 2b trial tests whether injecting allogeneic neural stem cells (CC-101) into the brain near a prior stroke lesion can improve motor function in adults with chronic ischemic stroke and lasting movement problems. About 36 participants will receive either stem cells plus short-term anti-rejection medication, stem cells plus placebo, or a sham surgery plus placebo. The study measures changes in motor skills one year after the procedure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- allogeneic neural stem cells CC-101 (f/k/a NR1) injected into the brain near the stroke lesion, plus short-term tacrolimus
- What this could lead to
- If successful, this could point toward a new treatment that helps people regain motor function years after a stroke.
- What could go wrong
- This is an early-phase trial with only 36 participants, so results may not apply broadly. Brain surgery carries risks like infection or bleeding, and the stem cells may not improve function.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
KEY INCLUSION CRITERIA: 1. Confirmed diagnosis of completed ischemic subcortical stroke in the middle cerebral artery (MCA) distribution with or without cortical involvement based on magnetic resonance imaging (MRI) and/or computed tomography (CT) scan(s). 2. Index stroke occurred ≥ 6 months and ≤ 84 months prior to providing informed consent. 3. Age ≥ 18 years and ≤ 75 years at the time of providing informed consent. 4. Chronic motor neurological deficit due to the index stroke. 5. Total Fugl-Meyer Motor Scale (FMMS) \> 25 and ≤ 75 at baseline. 6. Modified Rankin Score (mRS) of 2-4 at baseline. 7. Subjects taking oral anti-spasticity agent (such as tizanidine hydrochloride or baclofen) must be on a stable dose for 90 days prior to a Screening/Baseline visit. KEY EXCLUSION CRITERIA: 1. Stroke lesion \<1 cm3 or \>100 cm3 as measured by MRI. 2. Previous history of symptomatic stroke(s) with incomplete motor recovery (NOT including index stroke). 3. Complete or near complete lack of right and/or left upper extremity and/or right and/or left lower extremity movement as defined by the MRC Scale for Muscle Strength scores. 4. History of any neuromuscular, rheumatologic, autoimmune, orthopedic, or other disease or condition that limits motor function. 5. Acute myocardial infarction (heart attack), acute pulmonary embolism (blood clot to the lungs), acute proximal deep vein thrombosis (blood clot in the leg or arm), acute peripheral arterial occlusion, or any other type of acute blood clotting episode within six (6) months of study screening. 6. Intracoronary and/or other intra-arterial stent placement within 12 months of study Screening/Baseline visits requiring uninterrupted anticoagulant and/or anti-platelet therapy. 7. Contracture involving a shoulder, elbow, wrist, finger, hip, knee, and/or ankle. 8. Any contraindication to stereotactic brain surgery. 9. Presence of serum anti-Human Leukocyte Antigen (HLA) Class I and/or Class II antibodies to donor NR1 cells with a Luminex assay value greater than the larger of the central lab's reference ULN or 3,000 Maximum Fluorescence Intensity.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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