CC-101 (f/k/a NR1) Neural Stem Cell Transplantation for Adults With Chronic Ischemic Stroke (suNR1se II)
2026年7月12日 更新者：Clarion Cells, Inc.
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.
調査の概要
状態
まだ募集していません
条件
詳細な説明
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.
研究の種類
介入
入学 (推定)
36
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Ruth Antoine, MS, MBA
- 電話番号：732-551-6611
- メール：rantoine@clarioncells.com
研究連絡先のバックアップ
- 名前：Steven R Deitcher, MD
- メール：srdeitcher@clarioncells.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
KEY INCLUSION CRITERIA:
- 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.
KEY EXCLUSION CRITERIA:
- 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.
- 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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：CC-101 (f/k/a NR1) + oral Tacrolimus [ARM A]
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.
|
Investigational allogeneic neural stem cell product administered stereotactically via intracerebral injection immediately adjacent to the prior stroke lesion.
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.
|
|
偽コンパレータ：Partial thickness burr hole without any cells + oral Tacrolimus-matched placebo [ARM B]
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.
|
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.
|
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実験的：CC-101 (f/k/a 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.
|
Investigational allogeneic neural stem cell product administered stereotactically via intracerebral injection immediately adjacent to the prior stroke lesion.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total Fugl-Meyer Motor Scale (FMMS) Score on Day +365 Following Neurosurgical Intervention (CC-101 transplantation or sham surgery) on Day 0.
時間枠：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.
|
Baseline to Day +365.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total Fugl-Meyer Motor Scale (FMMS) Score on Day +365 Following Neurosurgical Intervention (CC-101 transplantation or sham surgery) on Day 0.
時間枠：Baseline to Day +365.
|
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.
|
Baseline to Day +365.
|
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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.
時間枠：Baseline to Day +90 and baseline to Day +182
|
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.
|
Baseline to Day +90 and baseline to Day +182
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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.
時間枠：Baseline to Day +90 and baseline to Day +182.
|
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.
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Baseline to Day +90 and baseline to Day +182.
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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.
時間枠：Baseline to Day +365.
|
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.
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Baseline to Day +365.
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Barthel Index on Day +90 and Day +182 Following Neurosurgical Intervention (CC-101 transplantation or sham surgery) on Day 0.
時間枠：Baseline to Day +90 and baseline to Day +182.
|
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.
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Baseline to Day +90 and baseline to Day +182.
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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..
時間枠：Baseline to Day +365.
|
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.
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Baseline to Day +365.
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Overall Survival on Day +90, Day +182, and Day +365 Following Neurosurgical Intervention (CC-101 transplantation or sham surgery) on Day 0.
時間枠：Survival rates at Day +90, Day +182, and Day +365.
|
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.
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Survival rates at Day +90, Day +182, and Day +365.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディチェア：Gary K Steinberg, MD, PhD、Stanford University School of Medicine, Department of Neurosurgery
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2027年1月1日
一次修了 (推定)
2029年1月1日
研究の完了 (推定)
2029年1月1日
試験登録日
最初に提出
2026年7月12日
QC基準を満たした最初の提出物
2026年7月12日
最初の投稿 (実際)
2026年7月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月17日
QC基準を満たした最後の更新が送信されました
2026年7月12日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- NR1-03
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
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