Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury
調査の概要
状態
条件
詳細な説明
The proposed study will assess primary safety and secondary efficacy endpoints of autologous bone marrow mononuclear cells and allogeneic human umbilical cord-derived mesenchymal stem cells administered to 20 male and female subjects between ages of 18-50 with spinal cord injury. These cells will be administered intrathecally and intravenously multiple times over the course of one month.
The primary objective is freedom from treatment-associated adverse events at 3 and 12 months post-treatment. Secondary objective will be efficacy at baseline, 3 months and 12 months and will be quantified based on the following: American Spinal Cord Injury Association (ASIA) classification and the Frankel Scale.
研究の種類
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
-
-
-
Panama City、パナマ
- Stem Cell Institute
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Men and women between age 18 and 50
- Paraplegics and quadriplegics with complete or incomplete spinal cord injuries.
- Willingness to undergo bone marrow derived autologous cell therapy.
- Ability and willingness to make regular visits to hospital and follow ups during the protocol procedure and comply with all medical instructions
- Traumatic Injury of spinal cord with complete or partial damage by Magnetic Resonance Imaging (MRI) and injury level below C4
- ASIA impairment scale from A - C
- Must have proof of health insurance in country of residence.
- Signed informed consent
Exclusion Criteria:
- Pre- existing or current systemic disease such as lung, liver (exception: history of uncomplicated hepatitis A), gastrointestinal, cardiac, Human Immunodeficiency Virus (HIV)
- History of life threatening allergic- or immune-mediated reaction
- Hemodynamic instability
- Peripheral muscular dystrophy
- Lactating or pregnant woman
- Women capable of childbearing unwilling to use multiple forms of contraception
- Alcohol drug abuse /dependence
- Positive test result for hepatitis A and Hepatitis B OR C
- Major-traumatic brain injury and psychiatric illness
- Open injuries
- Active infectious diseases
- Life expectancy of less than one year due to terminal condition
- Neurodegenerative diseases
- Primary hematologic diseases
Any of the following medications that cannot be discontinued one week prior to the first stem cell administration and throughout the course of treatment. (1 week before visit 2 through one week after visit 12)
- Antibiotics
- Antifungals
- Antivirals
- Blood thinners (to avoid bleeding risk during bone marrow aspiration and IT procedures)
- High doses of Vitamin D or fish oils (since these might prolong bleeding times)
- Bone reflecting increased risk for spinal puncture
- Hepatic dysfunction
- Other medical complications that contraindicate surgery, including major respiratory complications
- Participation in another clinical trial
- Coagulopathies
- Uncorrected coagulopathy during the baseline period defined as: International Normalized Ratio (INR) > 1.4; Partial Thromboplastin Time (PTT) > 35 sec; Platelet Count (PLT) < 100,000.
- Pre-injury history of seizure disorder and/or neurological impairment where participation in age-appropriate pain rating scales would not be practical or possible
- Subject does not sign informed consent form
研究計画
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 |
|---|---|
|
実験的：IV and IT UC-MSC and BMMC
Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells
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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 |
|---|---|---|
|
Number of patients with adverse events
時間枠：12 weeks, 52 weeks
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12 and 52 weeks after final treatment
|
12 weeks, 52 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of subjects with a change in American Spinal Injury Association (ASIA) score from baseline
時間枠：12 weeks, 52 weeks
|
12 and 52 weeks after final treatment
|
12 weeks, 52 weeks
|
|
Number of subjects with a change in Frankel Scale score from baseline
時間枠：12 weeks, 52 weeks
|
12 and 52 weeks from final treatment
|
12 weeks, 52 weeks
|
協力者と研究者
捜査官
- 主任研究者：Nelson Novarro, MD
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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。