[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647555":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":42,"centralContacts":47,"locations":31,"responsibleParty":56,"collaborators":31,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":31,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":92,"whyStopped":31,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":31},{"fullName":5,"class":6},"Clarion Cells, Inc.","INDUSTRY",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"CC-101 (f\u002Fk\u002Fa 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.",[13,14],"Biological: CC-101 (f\u002Fk\u002Fa NR1) Intracerebral Transplantation","Drug: Tacrolimus",{"label":16,"type":17,"description":18,"interventionNames":19},"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.",[20],"Procedure: Sham Surgical Control",{"label":22,"type":10,"description":23,"interventionNames":24},"CC-101 (f\u002Fk\u002Fa NR1) + oral Tacrolimus-matched placebo [ARM C]","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.",[13],[26,32,37],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BIOLOGICAL","CC-101 (f\u002Fk\u002Fa NR1) Intracerebral Transplantation","Investigational allogeneic neural stem cell product administered stereotactically via intracerebral injection immediately adjacent to the prior stroke lesion.",[9,22],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"DRUG","Tacrolimus","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.",[9],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":31},"PROCEDURE","Sham Surgical Control","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.",[16],[43],{"name":44,"affiliation":45,"role":46},"Gary K Steinberg, MD, PhD","Stanford University School of Medicine, Department of Neurosurgery","STUDY_CHAIR",[48,53],{"name":49,"role":50,"phone":51,"phoneExt":31,"email":52},"Ruth Antoine, MS, MBA","CONTACT","732-551-6611","rantoine@clarioncells.com",{"name":54,"role":50,"phone":31,"phoneExt":31,"email":55},"Steven R Deitcher, MD","srdeitcher@clarioncells.com",{"type":57,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100647555","phase-2-cc-101-fka-nr1-neural-stem-cell-transplantation-for-adults-with-chronic-ischemic-stroke-100647555",false,"NCT07709845","CC-101 (f\u002Fk\u002Fa NR1) Neural Stem Cell Transplantation for Adults With Chronic Ischemic Stroke","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\u002Fk\u002Fa NR1) in Adults With Chronic Ischemic Subcortical ± Cortical Stroke","suNR1se II","KEY INCLUSION CRITERIA:\n\n1. 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\u002For computed tomography (CT) scan(s).\n2. Index stroke occurred ≥ 6 months and ≤ 84 months prior to providing informed consent.\n3. Age ≥ 18 years and ≤ 75 years at the time of providing informed consent.\n4. Chronic motor neurological deficit due to the index stroke.\n5. Total Fugl-Meyer Motor Scale (FMMS) \\> 25 and ≤ 75 at baseline.\n6. Modified Rankin Score (mRS) of 2-4 at baseline.\n7. 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\u002FBaseline visit.\n\nKEY EXCLUSION CRITERIA:\n\n1. Stroke lesion \\\u003C1 cm3 or \\>100 cm3 as measured by MRI.\n2. Previous history of symptomatic stroke(s) with incomplete motor recovery (NOT including index stroke).\n3. Complete or near complete lack of right and\u002For left upper extremity and\u002For right and\u002For left lower extremity movement as defined by the MRC Scale for Muscle Strength scores.\n4. History of any neuromuscular, rheumatologic, autoimmune, orthopedic, or other disease or condition that limits motor function.\n5. 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.\n6. Intracoronary and\u002For other intra-arterial stent placement within 12 months of study Screening\u002FBaseline visits requiring uninterrupted anticoagulant and\u002For anti-platelet therapy.\n7. Contracture involving a shoulder, elbow, wrist, finger, hip, knee, and\u002For ankle.\n8. Any contraindication to stereotactic brain surgery.\n9. Presence of serum anti-Human Leukocyte Antigen (HLA) Class I and\u002For 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.","ALL","18 Years","75 Years",{"count":70,"type":71},36,"ESTIMATED","INTERVENTIONAL",[74],"PHASE2","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\u002Fk\u002Fa 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.",[77],"Chronic Ischemic Stroke",[79,80,81,82,83,84,85,86,87,88,89,90,91],"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","NOT_YET_RECRUITING","2026-07-12",{"date":95,"type":96},"2026-07-17","ACTUAL",{"date":98,"type":71},"2027-01",{"date":100,"type":71},"2029-01",{"name":5,"class":6}]