Brain stem cell transplant aims to restore movement after stroke

NCT ID NCT07709845

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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

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