Chronic Ischemic StrokePhase 2suNR1se IINCT07709845
CC-101 (f/k/a NR1) Neural Stem Cell Transplantation for Adults With Chronic Ischemic Stroke
A Phase 2 study testing CC-101 (f/k/a NR1) Intracerebral Transplantation and Tacrolimus in people with Chronic Ischemic Stroke, run by Clarion Cells, Inc..
Trial summary
The suNR1se II Study is a Phase 2b randomized, controlled, multi-center clinical trial evaluating the efficacy and safety of stereotactic intracerebral administration of CC-101 (f/k/a NR1), an investigational allogeneic neural stem cell therapy, in adults with chronic ischemic stroke and persistent motor impairment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Ischemic Stroke
- What is being tested?
- CC-101 (f/k/a NR1) Intracerebral Transplantation and Tacrolimus
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- Index stroke occurred ≥ 6 months and ≤ 84 months prior to providing informed consent.
- Age ≥ 18 years and ≤ 75 years at the time of providing informed consent.
- Chronic motor neurological deficit due to the index stroke.
- Total Fugl-Meyer Motor Scale (FMMS) > 25 and ≤ 75 at baseline.
- Modified Rankin Score (mRS) of 2-4 at baseline.
- 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.
Who cannot join
- Stroke lesion <1 cm3 or >100 cm3 as measured by MRI.
- Previous history of symptomatic stroke(s) with incomplete motor recovery (NOT including index stroke).
- 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.
- History of any neuromuscular, rheumatologic, autoimmune, orthopedic, or other disease or condition that limits motor function.
- 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.
- Intracoronary and/or other intra-arterial stent placement within 12 months of study Screening/Baseline visits requiring uninterrupted anticoagulant and/or anti-platelet therapy.
Show all 9Show fewer
- Contracture involving a shoulder, elbow, wrist, finger, hip, knee, and/or ankle.
- Any contraindication to stereotactic brain surgery.
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Steven R Deitcher, MD contact
About this study
Official title: A Phase 2b, Prospective, Randomized, Multi-Center, Double-Blinded, Controlled Trial to Assess the Efficacy and Safety of Stereotactic Intracerebral Transplantation of Allogeneic Neural Stem Cells CC-101 (f/k/a NR1) in Adults With Chronic Ischemic Subcortical ± Cortical Stroke
The suNR1se II Study is a Phase 2b randomized, controlled, multi-center clinical trial evaluating the efficacy and safety of stereotactic intracerebral administration of CC-101 (f/k/a NR1), an investigational allogeneic neural stem cell therapy, in adults with chronic ischemic stroke and persistent motor impairment. The study is designed to assess whether administration of CC-101 immediately adjacent to the region of prior stroke injury may improve motor function recovery compared with a sham surgical control procedure. The study will also evaluate the role of short-term anti-rejection therapy with tacrolimus in subjects receiving CC-101. Approximately 36 participants will be randomized in a 1:1:1 ration to receive CC-101 plus tacrolimus, sham surgery (no CC-101) plus tacrolimus-matched placebo, or CC-101 plus tacrolimus-matched placebo. Participants will be followed for safety and functional outcomes for at least 12 months following the study procedure.
Read the detailed description
CC-101 (f/k/a NR1) is an investigational allogeneic neural stem cell therapy being developed to support endogenous repair and regenerative mechanisms within the brain following ischemic injury and infarction (i.e., ischemic stroke). Rather than directly replacing stroke-damaged and dead brain cells and tissue, CC-101 is intended to promote recovery through local production of biologically active factors that support neurogenesis (i.e., new brain cell production), angiogenesis (i.e., new blood vessel formation), plasticity (i.e., rewiring of synaptic connections), extracellular matrix remodeling (i.e., change materials around brain cells), and modulation of inflammation. The suNR1se II Study is a prospective, randomized, controlled Phase 2b study designed to evaluate the efficacy and safety of stereotactic intracerebral administration of CC-101 in adults with chronic ischemic subcortical ischemic stroke, with or without adjacent cortical involvement. Participants will be randomized equally to one of three study arms: 1) CC-101 plus tacrolimus (Experimental Arm A), 2) sham surgery plus placebo (Control Arm B), or 3) CC-101 plus placebo (Exploratory Arm C). The inclusion of sham surgery control (Arm B) and tacrolimus-matched placebo anti-rejection therapy (Arms B \& C) is intended to support rigorous evaluation of CC-101 treatment effect and further characterization of the role of tacrolimus in allogeneic neural stem cell therapy for chronic ischemic stroke. The primary efficacy assessment will evaluate changes in arm and leg motor functions between baseline and 12 months following intervention. Safety assessments will include adverse events, serious adverse events, neurosurgical complications, imaging findings, laboratory assessments, hospitalization events, and mortality.
- Conditions
- Chronic Ischemic Stroke
- Being tested
- CC-101 (f/k/a NR1) Intracerebral Transplantation, Tacrolimus, Sham Surgical Control
- Keywords
- Ischemic Stroke, Neural Stem Cells, Stroke, Allogeneic Cell Therapy, Stroke Rehabilitation, Neuroregeneration, Intracerebral Transplantation, Motor Recovery, Chronic Stroke, Stroke Impairment, Stroke Mobility Impairment, Regenerative Medicine, Cell Therapy
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-101 (f/k/a NR1) Intracerebral TransplantationBiological
Investigational allogeneic neural stem cell product administered stereotactically via intracerebral injection immediately adjacent to the prior stroke lesion.
TacrolimusDrug
Oral tacrolimus or tacrolimus-matched placebo initiated prior to study intervention and continued for approximately 60 days following study intervention per protocol-defined dosing and taper schedule.
Sham Surgical ControlProcedure or surgery
Participants will undergo a partial thickness burr hole craniotomy without disruption of the meninges or transplantation of any cells as a means to maintain treatment masking.
| Study group | Role | What they receive |
|---|---|---|
| CC-101 (f/k/a NR1) + oral Tacrolimus [ARM A] | Experimental | Participants will receive stereotactic intracerebral administration of investigational CC-101 allogeneic neural stem cells on Day 0 plus twice-daily oral tacrolimus anti-rejection therapy from Day -2 to Day +60. Receives: Biological: CC-101 (f/k/a NR1) Intracerebral Transplantation; Drug: Tacrolimus |
| Partial thickness burr hole without any cells + oral Tacrolimus-matched placebo [ARM B] | Sham comparator | Participants will undergo a sham surgical control procedure on Day 0 designed to preserve study blinding along with twice-daily oral tacrolimus-matched placebo from Day -2 to Day +60. Receives: Procedure: Sham Surgical Control |
| CC-101 (f/k/a NR1) + oral Tacrolimus-matched placebo [ARM C] | Experimental | Participants will receive stereotactic intracerebral administration of investigational CC-101 allogeneic neural stem cells on Day 0 plus twice-daily oral tacrolimus-matched placebo therapy from Day -2 to Day +60. Receives: Biological: CC-101 (f/k/a NR1) Intracerebral Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Fugl-Meyer Motor Scale (FMMS) Score on Day +365 Following Neurosurgical Intervention (CC-101 transplantation or sham surgery) on Day 0.
The total Fugl-Meyer Motor Scale (FMMS) score (0-100; the larger the better) reflects the sum of the upper extremity (0-66) and lower extremity (0-34) FMMS scores. For each study subject, this clinical assessment of motor function on Day +365 will be compared with the baseline total FMMS score to determine the interval change in motor function.
Measured: Baseline to Day +365.
Secondary outcomes (7)
Total Fugl-Meyer Motor Scale (FMMS) Score on Day +365 Following Neurosurgical Intervention (CC-101 transplantation or sham surgery) on Day 0.
Each study subject will be categorized as having an increase in total FMMS score of ≥10 points or an increase of <10 points (including unchanged scores and decreased scores) between baseline assessment and assessment on Day +365 following neurosurgical intervention.
Measured: Baseline to Day +365.
Total Fugl-Meyer Motor Scale (FMMS) Score on Day +90 and Day +182 Following Neurosurgical Intervention (CC-101 transplantation or sham surgery) on Day 0.
For each study subject, this clinical assessment of motor function on Day +90 and Day +182 will be compared with the baseline total FMMS score to determine the interval change in motor function.
Measured: Baseline to Day +90 and baseline to Day +182
Total Fugl-Meyer Motor Scale (FMMS) Score on Day +90 and Day +182 Following Neurosurgical Intervention (CC-101 transplantation or sham surgery) on Day 0.
Each study subject will be categorized as having an increase in total FMMS score of ≥10 points or an increase of <10 points (including unchanged scores and decreased scores) between baseline assessment and assessments on Day +90 and on Day +182 following neurosurgical intervention.
Measured: Baseline to Day +90 and baseline to Day +182.
Upper Extremity Motor Function as Assessed by the Action Research Arm Test (ARAT) on Day +365 Following Neurosurgical Intervention (CC-101 transplantation or sham surgery) on Day 0.
Each study subject will be categorized as having an increase in ARAT score of ≥5.7 points or an increase of <5.7 points (including unchanged scores and decreased scores) between baseline assessment and assessment on Day +365 following neurosurgical intervention.
Measured: Baseline to Day +365.
Barthel Index on Day +90 and Day +182 Following Neurosurgical Intervention (CC-101 transplantation or sham surgery) on Day 0.
For each study subject, this clinical assessment of functional independence on Day +90 and Day +182 will be compared with the baseline Barthel Index to determine the interval change.
Measured: Baseline to Day +90 and baseline to Day +182.
Gait Velocity Using the Comfortable Gait Speed Test Measuring 10 Meters of Timed Gait Speed on Day +365 Following Neurosurgical Intervention (CC-101 transplantation or sham surgery) on Day 0..
Each study subject will be categorized as having or not having an improvement in gait function by at least one functional level using the 10-meter walk test between baseline assessment and assessment on Day +365 following neurosurgical intervention.
Measured: Baseline to Day +365.
Overall Survival on Day +90, Day +182, and Day +365 Following Neurosurgical Intervention (CC-101 transplantation or sham surgery) on Day 0.
Subject survival to key assessment milestones will be assessed. Time to all-cause subject death following study Day 0 neurosurgery will be estimated using the product-limit (Kaplan-Meier) method.
Measured: Survival rates at Day +90, Day +182, and Day +365.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1:1 allocation ratio to one of three parallel treatment groups evaluating CC-101 (f/k/a NR1) allogeneic neural stem cell therapy with or without active, short-term, oral anti-rejection drug therapy, compared with a sham surgical control. About two-thirds of study participants will receive intracerebral CC-101 transplantation, while one-third will receive sham surgery.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clarion Cells, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary K Steinberg, MD, PhD, Study chair, Stanford University School of Medicine, Department of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709845
- Sponsor's protocol ID
- NR1-03
- Acronym
- suNR1se II
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Prospective, Randomized, Multi-Center, Double-Blinded, Controlled Trial to Assess the Efficacy and Safety of Stereotactic Intracerebral Transplantation of Allogeneic Neural Stem Cells CC-101 (f/k/a NR1) in Adults With Chronic Ischemic Subcortical ± Cortical Stroke
- ClinicalTrials.gov ID
- NCT07709845
- Acronym / sponsor ID
- suNR1se II / NR1-03
- Conditions
- Chronic Ischemic Stroke
- Keywords
- Ischemic Stroke, Neural Stem Cells, Stroke, Allogeneic Cell Therapy, Stroke Rehabilitation, Neuroregeneration, Intracerebral Transplantation, Motor Recovery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Clarion Cells, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The suNR1se II Study is a Phase 2b randomized, controlled, multi-center clinical trial evaluating the efficacy and safety of stereotactic intracerebral administration of CC-101 (f/k/a NR1), an investigational allogeneic neural stem cell therapy, in adults with chronic ischemic stroke and persistent motor impairment. The study is designed to assess whether administration of CC-101 immediately adjacent to the region of prior stroke injury may improve motor function recovery compared with a sham surgical control procedure. The study will also evaluate the role of short-term anti-rejection therapy with tacrolimus in subjects receiving CC-101. Approximately 36 participants will be randomized in a 1:1:1 ration to receive CC-101 plus tacrolimus, sham surgery (no CC-101) plus tacrolimus-matched placebo, or CC-101 plus tacrolimus-matched placebo. Participants will be followed for safety and functional outcomes for at least 12 months following the study procedure.
Detailed description
CC-101 (f/k/a NR1) is an investigational allogeneic neural stem cell therapy being developed to support endogenous repair and regenerative mechanisms within the brain following ischemic injury and infarction (i.e., ischemic stroke). Rather than directly replacing stroke-damaged and dead brain cells and tissue, CC-101 is intended to promote recovery through local production of biologically active factors that support neurogenesis (i.e., new brain cell production), angiogenesis (i.e., new blood vessel formation), plasticity (i.e., rewiring of synaptic connections), extracellular matrix remodeling (i.e., change materials around brain cells), and modulation of inflammation. The suNR1se II Study is a prospective, randomized, controlled Phase 2b study designed to evaluate the efficacy and safety of stereotactic intracerebral administration of CC-101 in adults with chronic ischemic subcortical ischemic stroke, with or without adjacent cortical involvement. Participants will be randomized equally to one of three study arms: 1) CC-101 plus tacrolimus (Experimental Arm A), 2) sham surgery plus placebo (Control Arm B), or 3) CC-101 plus placebo (Exploratory Arm C). The inclusion of sham surgery control (Arm B) and tacrolimus-matched placebo anti-rejection therapy (Arms B \& C) is intended to support rigorous evaluation of CC-101 treatment effect and further characterization of the role of tacrolimus in allogeneic neural stem cell therapy for chronic ischemic stroke. The primary efficacy assessment will evaluate changes in arm and leg motor functions between baseline and 12 months following intervention. Safety assessments will include adverse events, serious adverse events, neurosurgical complications, imaging findings, laboratory assessments, hospitalization events, and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomized in a 1:1:1 allocation ratio to one of three parallel treatment groups evaluating CC-101 (f/k/a NR1) allogeneic neural stem cell therapy with or without active, short-term, oral anti-rejection drug therapy, compared with a sham surgical control. About two-thirds of study participants will receive intracerebral CC-101 transplantation, while one-third will receive sham surgery.
| Arm | Type | Receives |
|---|---|---|
| CC-101 (f/k/a NR1) + oral Tacrolimus [ARM A] | Experimental | Biological: CC-101 (f/k/a NR1) Intracerebral Transplantation, Drug: TacrolimusParticipants will receive stereotactic intracerebral administration of investigational CC-101 allogeneic neural stem cells on Day 0 plus twice-daily oral tacrolimus anti-rejection therapy from Day -2 to Day +60. |
| Partial thickness burr hole without any cells + oral Tacrolimus-matched placebo [ARM B] | Sham comparator | Procedure: Sham Surgical ControlParticipants will undergo a sham surgical control procedure on Day 0 designed to preserve study blinding along with twice-daily oral tacrolimus-matched placebo from Day -2 to Day +60. |
| CC-101 (f/k/a NR1) + oral Tacrolimus-matched placebo [ARM C] | Experimental | Biological: CC-101 (f/k/a NR1) Intracerebral TransplantationParticipants will receive stereotactic intracerebral administration of investigational CC-101 allogeneic neural stem cells on Day 0 plus twice-daily oral tacrolimus-matched placebo therapy from Day -2 to Day +60. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
- Index stroke occurred ≥ 6 months and ≤ 84 months prior to providing informed consent.
- Age ≥ 18 years and ≤ 75 years at the time of providing informed consent.
- Chronic motor neurological deficit due to the index stroke.
- Total Fugl-Meyer Motor Scale (FMMS) > 25 and ≤ 75 at baseline.
Key exclusion criteria (9 listed)
- Stroke lesion <1 cm3 or >100 cm3 as measured by MRI.
- Previous history of symptomatic stroke(s) with incomplete motor recovery (NOT including index stroke).
- 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.
- History of any neuromuscular, rheumatologic, autoimmune, orthopedic, or other disease or condition that limits motor function.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CC-101 (f/k/a NR1) Intracerebral TransplantationInvestigational allogeneic neural stem cell product administered stereotactically via intracerebral injection immediately adjacent to the prior stroke lesion. | Biological | CC-101 (f/k/a NR1) + oral Tacrolimus [ARM A], CC-101 (f/k/a NR1) + oral Tacrolimus-matched placebo [ARM C] |
| TacrolimusOral tacrolimus or tacrolimus-matched placebo initiated prior to study intervention and continued for approximately 60 days following study intervention per protocol-defined dosing and taper schedule. | Drug | CC-101 (f/k/a NR1) + oral Tacrolimus [ARM A] |
| Sham Surgical ControlParticipants will undergo a partial thickness burr hole craniotomy without disruption of the meninges or transplantation of any cells as a means to maintain treatment masking. | Procedure or surgery | Partial thickness burr hole without any cells + oral Tacrolimus-matched placebo [ARM B] |
Primary outcome
Total Fugl-Meyer Motor Scale (FMMS) Score on Day +365 Following Neurosurgical Intervention (CC-101 transplantation or sham surgery) on Day 0.
Time frame: Baseline to Day +365.
The total Fugl-Meyer Motor Scale (FMMS) score (0-100; the larger the better) reflects the sum of the upper extremity (0-66) and lower extremity (0-34) FMMS scores. For each study subject, this clinical assessment of motor function on Day +365 will be compared with the baseline total FMMS score to determine the interval change in motor function.
7 secondary outcomes
Total Fugl-Meyer Motor Scale (FMMS) Score on Day +365 Following Neurosurgical Intervention (CC-101 transplantation or sham surgery) on Day 0.
Time frame: Baseline to Day +365.
Total Fugl-Meyer Motor Scale (FMMS) Score on Day +90 and Day +182 Following Neurosurgical Intervention (CC-101 transplantation or sham surgery) on Day 0.
Time frame: Baseline to Day +90 and baseline to Day +182
Total Fugl-Meyer Motor Scale (FMMS) Score on Day +90 and Day +182 Following Neurosurgical Intervention (CC-101 transplantation or sham surgery) on Day 0.
Time frame: Baseline to Day +90 and baseline to Day +182.
Upper Extremity Motor Function as Assessed by the Action Research Arm Test (ARAT) on Day +365 Following Neurosurgical Intervention (CC-101 transplantation or sham surgery) on Day 0.
Time frame: Baseline to Day +365.
Barthel Index on Day +90 and Day +182 Following Neurosurgical Intervention (CC-101 transplantation or sham surgery) on Day 0.
Time frame: Baseline to Day +90 and baseline to Day +182.
Gait Velocity Using the Comfortable Gait Speed Test Measuring 10 Meters of Timed Gait Speed on Day +365 Following Neurosurgical Intervention (CC-101 transplantation or sham surgery) on Day 0..
Time frame: Baseline to Day +365.
Overall Survival on Day +90, Day +182, and Day +365 Following Neurosurgical Intervention (CC-101 transplantation or sham surgery) on Day 0.
Time frame: Survival rates at Day +90, Day +182, and Day +365.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven R Deitcher, MD contact
Gary K Steinberg, MD, PhD study chair
Stanford University School of Medicine, Department of Neurosurgery
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CC-101 (f/k/a NR1) Intracerebral Transplantation and Tacrolimus in people with Chronic Ischemic Stroke, run by Clarion Cells, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruth Antoine, MS, MBA (732-551-6611, rantoine@clarioncells.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Fugl-Meyer Motor Scale (FMMS) Score on Day +365 Following Neurosurgical Intervention (CC-101 transplantation or sham surgery) on Day 0. (time frame: Baseline to Day +365.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.