Study of Purified Umbilical Cord Blood CD34+ Stem Cell on Chronic Ischemic Stroke
2012年7月31日 更新者:Shinn-Zong Lin、China Medical University Hospital
An Exploratory Clinical Trial to Assess Treatment of Chronic Ischemic Stroke With Brain Transplants of Purified CD34+ Umbilical Cord Blood Stem Cells
The purpose of the study is to determine the safety and possible effectiveness of brain transplants of CD34+ stem cells obtained from umbilical cord blood (UCB) to treat stroke.
調査の概要
状態
わからない
詳細な説明
The study will use CD34+ cells (a special kind of cell that is believed to be a stem cell) isolated from UCB (blood obtained at birth from the umbilical cord blood of babies).
StemCyte, a leading accredited UCB banking company with branches in the United States and Taiwan, will provide the units of UCB that match at least 5 out of 6 HLA (human leukocyte antigens) for transplantation.
The HLA-matching is the same as that used to match cells and organs for transplantation so that the body does not reject the cells.
We will isolate CD34 cells from these units, purified them, suspend the cells in solution (1 ml containing 2-8 million cells), and inject the cells into brain around the site damaged by the stroke
研究の種類
介入
入学 (予想される)
6
段階
- フェーズ 1
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。
研究場所
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Taichung、台湾、244
- China Medical University Hospital
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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
35年~70年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Subjects can be of either gender and must be between 35 through 75 years of age.
- Subjects must have had ischemic stroke more than 6 and less than 60 months ago.
- Subjects must have stable hemiplegia or hemiparesis condition at least for 3 months.
- Subjects must have stroke-induced clinical deficits affecting motor, perceptual, or language functions, with a National Institutes of Health Stroke Scale (NIHSS) of 5-15.
- Subjects must have stroke in the middle cerebral artery territory.
- Subjects must have an available umbilical cord blood unit that has an HLA-match of at least 5:6 (HLA-A, -B, and -DR).
- Subjects must be able to read and understand the informed consent form that has been approved by the appropriate Institutional Review Board (IRB). The subject must sign and date the informed consent form before any study-specific procedures. (Note: If a subject consents to participation but is not in a position to sign and date the informed consent form personally because of his or her physical conditions, the consent form must be confirmed orally at the time of consent, marked or finger printed by the subject voluntarily). The informed consent procedure must be observed by an independent witness who is present throughout the whole informed consent process and sign the consent form.
Exclusion Criteria:
- Subject has evidence of a non-ischemic mechanism, subarachnoid hemorrhage, primary intracerebral or intraventricular hemorrhage or MRI has shown that the occlusion is not in the middle cerebral artery territory.
- Pregnant or lactating women.
- History of alcohol or drug abuse in the previous 3 months.
Subjects must not have the following conditions in documents:
- significant renal, cardiovascular, hepatic, or psychiatric disease
- abnormal blood coagulation parameters,
- immunodeficiency (e.g. AIDS)
- tumors, leukemia, and other cancer that may interfere with the clinical trial protocol
- infectious diseases, including hepatitis, or other conditions that may be a contraindication to the planned therapies and evaluation.
- Subject must not be currently participating in another investigational study or taking any investigational drug within the last four weeks before the screening of this study.
- Any other condition that, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol and would not be suitable to perform a surgery or to participate in the study.
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:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:HUCB, Medicine, Rehabilitation
Stroke patients are received intracerebral implantation of human cord blood stem cells (CD34+), Antiplatelet Medication, and Rehabilitation.
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Each patient will receive brain implant of approximately 5 million allogenic Umbilical cord blood CD34+ Stem Cell
他の名前:
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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 |
|---|---|---|
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Change from baseline in NIH Stroke Scale (NIHSS)
時間枠:Change from baseline in NIHSS at 1 weeks
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Evaluate change from Baseline in NIHSS at 1 week
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Change from baseline in NIHSS at 1 weeks
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Change from Baseline in NIH Stroke Scale(NIHSS)
時間枠:Change from Baseline in NIHSS at 2 weeks
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Evaluate change from Baseline in NIHSS at 2 weeks
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Change from Baseline in NIHSS at 2 weeks
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Change from baseline in NIH Stroke Scale
時間枠:Change from baseline in NIHSS at 4 weeks
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Evaluate change from baseline in NIHSS at 4 weeks
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Change from baseline in NIHSS at 4 weeks
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Change from baseline in NIH Stroke Scale ( NIHSS)
時間枠:Change from baseline in NIHSS at 12 weeks
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Evaluate change from baseline in NIHSS at 12 weeks
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Change from baseline in NIHSS at 12 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from baseline in Brain Image
時間枠:Change from baseline in Brain Image at 1 week
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Brain Image will be performed by MRI.
The MRI evaluation includes DEI, T1W, T2W, MRS, and DTI, and change from baseline will be evaluated at 1 week
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Change from baseline in Brain Image at 1 week
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Change from baseline in Brain Image
時間枠:Change from baseline in Brain Image at 4 weeks
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Brain Image will be performed by MRI.
The MRI evaluation includes DEI,T1W,T2W,MRS and DTI , and evaluate the change from baseline at 4 weeks
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Change from baseline in Brain Image at 4 weeks
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Change from baseline in Brain Image
時間枠:Change from baseline in Brain Image at 6 months
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Brain Image will be performed by MRI.MRI image includes DEI,T1W, T2W, and DTI, and change from baseline will be evaluated at 6 months.
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Change from baseline in Brain Image at 6 months
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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。
捜査官
- 主任研究者:Shinn-Zong Lin, M.D.;PhD.、China Medical University Hospital
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
2013年1月1日
一次修了 (予想される)
2013年12月1日
研究の完了 (予想される)
2013年12月1日
試験登録日
最初に提出
2011年9月7日
QC基準を満たした最初の提出物
2011年9月21日
最初の投稿 (見積もり)
2011年9月22日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年8月2日
QC基準を満たした最後の更新が送信されました
2012年7月31日
最終確認日
2011年12月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。