Dendritic Cells for Type 1 Diabetes Mellitus (T1DM) Therapy
Autologous Co-stimulation-impaired Dendritic Cells for Type 1 Diabetes Mellitus (T1DM) Therapy: A Sequential Open Label Phase IB Safety Assessment/ Randomized, Double-blind Phase IIA Efficacy Trial to Maintain and Improve Functional Beta Cell Mass in New Onset Disease T1DM Patients
Phase IB will evaluate the safety of autologous, ex vivo-engineered, co-stimulation impaired dendtritic cells to maintain and improve functional residual beta cell mass in new onset Type I Diabetes Mellitus (T1DM) patients. Efficacy measures will be collected and summarized.
Phase IIA will evaluate the safety and efficacy of 3 randomized treatment groups in new onset T1DM patients to assess if the antisense DNA-treated co-stimulation-impaired immunoregulatory dendritic cells (iDC) will safely preserve and/or increase B-cell mass resulting in improvement and/or normalization of blood glucose levels and glycated hemoglobin A1c.
調査の概要
研究の種類
入学 (予想される)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213
- UPMC
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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:(both open label phase IB safety and Phase IIA study):
- Patients with new onset T1DM (>18 years of age for the phase IB and then >16 (first 10 subjects), >12 years of age for the second 10 subjects, > 8 years for the next 10 subjects and, finally, >8 years of age for the remainder of the phase IIA patients) within 6 months of diabetes mellitus diagnosis.
- Evidence of decreased β-cell function as measured by C-peptide and blood glucose levels consistent with impaired glucose tolerance.
- Evidence of at least one high-risk HLA haplotype.
- Evidence of at least one diabetes-related autoantibody (e.g. IA-2, GAD, ZnT8) ,
- Adequate immune competence as assessed by immunoreactivity to alloantigens in mixed leukocyte culture and reactivity to viral antigens (CEF Pool Assay) in vitro.
- Normal hematologic, liver and kidney function.
- Female participants of childbearing potential in this study must agree to use an effective form of birth control during study participation. Reliable and effective forms of birth control include: true abstinence, intrauterine device (IUD), hormonal-based contraception, double-barrier contraception [condom or occlusive cap (diaphragm or cervical cap) with spermicide], or surgical sterilization (vasectomy for male partner, tubal ligation or hysterectomy). Sexually active male participants must agree to use an effective form of birth control such as condoms.
Exclusion Criteria:(both open label phase IB safety and Phase IIA study):
- Enrollment or history of enrollment in a drug, or biologic therapy study sponsored by TrialNet.
- A significant history or current evidence of cardiac disease, uncontrolled hypertension, serious arrhythmias.
- Evidence of active infection requiring antibiotic therapy.
- History of other concurrent significant medical diseases.
- Pregnant or lactating women.
- Patients requiring chronic systemic corticosteroids.
- Any other immune disorder including but not limited to other autoimmune diseases, HIV, HBV, HCV, HPV, HSV positivity.
- Impaired renal function with a creatinine level > 1.5.
- Administration of the following therapies while patients are undergoing treatment on this protocol: i) radiation therapy; ii) chemotherapy; iii) corticosteroids (except when administered in life-threatening circumstances); iv) other particle or cell-based therapies; v) other biologic therapies; vi) other therapies aimed at modulating the immune system; vii) other endocrine-related therapies, hormone replacement (other than thyroxine and contraceptive), glucoregulation.
- A hemaglobinopathy known to interfere with the ability to accurately determine HbA1c.
- No prior radiation therapy, immunotherapy, or chemotherapy.
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:トリプル
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:iDC recipients
iDC cells modified by in vitro engineering.
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アクティブコンパレータ:Control DC recipients
DC cells which have not been modified.
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プラセボコンパレーター:Placebo recipients
Saline injections.
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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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The incidence of treatment-emergent adverse events.
時間枠:Month 12
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Month 12
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二次結果の測定
結果測定 |
時間枠 |
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2-hour area under the curve (AUC) average of C-peptide at 12 months after completion of administration of assigned therapy (Protocol Month 15).
時間枠:12 Months
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12 Months
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協力者と研究者
スポンサー
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)
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。
Biologicalの臨床試験
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GlaxoSmithKline完了
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GlaxoSmithKline完了B型肝炎 | 破傷風 | ジフテリア | 無細胞百日咳 | 急性灰白髄炎 | ヘモフィルス インフルエンザ b型フィンランド
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Jiangsu Province Centers for Disease Control and...完了