Autologous Bone Marrow-derived Mononuclear Cells for Therapeutic Arteriogenesis in Patients With Limb Ischemia (ABC)
Autologous Bone Marrow-derived Mononuclear Cells for Therapeutic Arteriogenesis in Patients With Limb Ischemia A Double Blind, Placebo Controlled, Study in Diabetic and Non-diabetic Patients
調査の概要
詳細な説明
Although the safety and beneficial effects of intramuscular transplantation of bone marrow derived mononuclear cells procedure appear well documented, a number of critical question regarding application of BM-MNC for peripheral vascular disease remain to be answered. First, although the original study has been partially performed as semi-blinded study (patients with double sided claudication were recruited and blindly treated with BM-MNC in one leg and peripheral blood injections in the other leg), this approach does exclude a placebo effect. Second, although patients with mild diabetes were included in the protocol, the results for diabetic patients were not analyzed separately. Diabetic disease is characterized by monocyte and endothelial progenitor cell dysfunction and it is still unclear whether this approach is also effective in diabetic patients. Third, although six-month results are reported long-term efficacy has not been established yet.
To address these issues, the investigators now propose confirm and extend the findings from open studies in a randomized double-blind study in patients with severe claudication or critical leg ischemia and pay special attention to the influence of diabetic disease on the outcome of the study and to the possible pro-atherogenic/ pro-inflammatory effects of BM-MNC injections.
研究の種類
入学 (予想される)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究場所
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Leiden、オランダ、2300RC
- 募集
- Leiden University Medical Center
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コンタクト：
- Jan HN Lindeman, MD, PhD
- 電話番号：#31 (0)71 5263968
- メール：Lindeman@lumc.nl
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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:
- persistent (>3 months) disabling claudication (Fontaine's stages IIb or Rutherford's categories 3, viz. pain free walking distance less than 100 meter) despite optimal therapy or critical limb ischemia (Fontaine's stages III/IV or Rutherford's categories 4-6)
- ineligibility for angioplasty or bypass procedures
- male of female, >18 years old
- life expectancy > 1 year
- written informed consent
Exclusion Criteria:
- candidates for angioplasty or bypass procedures
- inability to undergo bone marrow harvesting
- any condition in the affected limb that is anticipated to require surgical intervention in the first weeks after BM-MNC treatment
- life threatening co-morbidity
- poorly controlled diabetes (HbA1C > 10%)
- active malignancy in the 5 years prior to treatment
- INR >1.5 at the time of bone-marrow harvest
- bleeding diathesis
- inability to undergo arterial catheterization
- inability to follow the protocol and to comply with the follow up requirements
- any other conditions that, in the opinion of the investigators, could interfere with the therapy or could pose a significant threat to the subject if the investigational therapy was to be initiated
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：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 |
|---|---|
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アクティブコンパレータ：1
non diabetic patients with Fontaine IIb-IV peripheral artery disease
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40 IM injections (calf muscle) of 1-8 10E9 mono nuclear cells
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プラセボコンパレーター：2
non diabetic patients with Fontaine IIb-IV peripheral artery disease
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40 IM injections (calf muscle) of placebo suspension
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アクティブコンパレータ：3
diabetic patients with Fontaine IIb-IV peripheral artery disease
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40 IM injections (calf muscle) of 1-8 10E9 mono nuclear cells
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プラセボコンパレーター：4
diabetic patients with Fontaine IIb-IV peripheral artery disease
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40 IM injections (calf muscle) of placebo suspension
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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 |
時間枠 |
|---|---|
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Limb salvage/wound healing at t=6 months; Pain free walking distance
時間枠：6 months
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6 months
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二次結果の測定
結果測定 |
時間枠 |
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quality of life (RAND-36), pain Scores (Brief Pain Inventory), tcO2 (wrist/ankle ratio) ABI Collateral artery scores (angiogram) at t=6 months, Limb salvage/wound healing at t= 3 and 12 months, Pain free walking distance at t=3 and 12 months,
時間枠：3, 6 and 12 months
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3, 6 and 12 months
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協力者と研究者
捜査官
- 主任研究者：Jan HN Lindeman, MD, PhD、Leiden University Medical Center
出版物と役立つリンク
一般刊行物
- Moazzami B, Mohammadpour Z, Zabala ZE, Farokhi E, Roohi A, Dolmatova E, Moazzami K. Local intramuscular transplantation of autologous bone marrow mononuclear cells for critical lower limb ischaemia. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD008347. doi: 10.1002/14651858.CD008347.pub4.
- Lindeman JHN, Zwaginga JJ, Kallenberg-Lantrua G, van Wissen RC, Schepers A, van Bockel HJ, Fibbe WE, Hamming JF. No Clinical Benefit of Intramuscular Delivery of Bone Marrow-derived Mononuclear Cells in Nonreconstructable Peripheral Arterial Disease: Results of a Phase-III Randomized-controlled Trial. Ann Surg. 2018 Nov;268(5):756-761. doi: 10.1097/SLA.0000000000002896.
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 (見積もり)
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。
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