HiCM-188 Cell Therapy in Adults With Advanced Heart Failure Undergoing Heart Bypass Surgery
A Phase I/IIa, Open-Label, Dose Escalation Study to Evaluate the Safety and Tolerability of HiCM-188, an Allogeneic iPSC-derived Cardiomyocyte Therapy, in Adult Patients With Advanced Heart Failure
This clinical study will evaluate the safety and tolerability of HiCM-188, an investigational allogeneic induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy, in adults with advanced heart failure who are undergoing coronary artery bypass grafting (CABG) surgery.
Participants who meet the study eligibility criteria will receive a single dose intramyocardial injection of HiCM-188 during CABG surgery. The study will evaluate two dose levels of HiCM-188 using an open-label dose-escalation design. Participants will be followed for up to 12 months after treatment to monitor safety and preliminary signs of clinical effect.
調査の概要
詳細な説明
This is a Phase I/IIa, open-label, dose-escalation study of HiCM-188 in adult participants with advanced heart failure. HiCM-188 is an investigational cell therapy product consisting of allogeneic human iPSC-derived cardiomyocytes intended for intramyocardial administration.
Eligible participants will receive HiCM-188 during coronary artery bypass grafting (CABG) surgery. The study uses a 3+3 dose-escalation design to evaluate two dose levels of HiCM-188: 0.5 × 10^8 cells and 1.5 × 10^8 cells. The primary objective is to evaluate the safety and tolerability of intramyocardial injection of HiCM-188. Secondary objectives include evaluation of preliminary efficacy based on cardiac function, myocardial perfusion, exercise capacity, NYHA functional classification, quality of life, and major adverse cardiac events.
Participants will be monitored during the in-hospital period after CABG surgery and HiCM-188 administration, and then followed for up to 12 months after treatment.
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Alex Zhang
- 電話番号：+1 650 504 5586
- メール：Alex.zhang@helptx.com.cn
研究場所
-
-
Texas
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Houston、Texas、アメリカ、77030
- The Texas Heart Institute at Baylor College of Medicine
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主任研究者：
- Emerson Perin
-
-
参加基準
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
説明
Inclusion Criteria:
- Able to sign informed consent and comply with the study protocol
- 18 to 75 years old at the time of signing informed consent
- Advanced heart failure patients with New York Heart Association (NYHA) class III to IVa despite receiving guideline-directed medical therapy (GDMT)
- Patients with an indication for coronary artery bypass grafting (CABG) per 2011 ACCF/AHA Guideline meeting a Class of Recommendation (COR) of Class I or Class IIa
- Minimum left ventricular wall thickness of ≥ 8 mm in the areas of injection, as confirmed on the screening echocardiogram (ECHO) or cardiac MRI
- Left ventricular ejection fraction (LVEF) of 20% to 45%, as confirmed on the screening echocardiogram (ECHO) or cardiac MRI
- Other criteria apply. Please contact the investigator for more information.
Exclusion Criteria:
- Viral myocarditis
- Amyloidosis
- Pericardial disorders or pericarditis
- Left ventricular aneurysm or thrombus, except a small laminar thrombus at the site of previous myocardial infarction (MI) in a different area
- Primary significant organic valvular heart disease, with specified dimensions
- Untreated congenital heart disease
- Complete atrioventricular (AV) conduction block
- History of left ventricular assist device surgery
- Other criteria apply. Please contact the investigator for more information.
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：非ランダム化
- 介入モデル：順次割り当て
- 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：HiCM-188 Low Dose
Participants in this arm will receive a single low dose of HiCM-188, 0.5 × 10^8 cells, administered by intramyocardial injection during coronary artery bypass grafting (CABG) surgery.
|
HiCM-188 is an investigational allogeneic human induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy administered as intramyocardial injection during CABG surgery.
|
|
実験的：HiCM-188 High Dose
Participants in this arm will receive a single high dose of HiCM-188, 1.5 × 10^8 cells, administered by intramyocardial injection during coronary artery bypass grafting (CABG) surgery.
|
HiCM-188 is an investigational allogeneic human induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy administered as intramyocardial injection during CABG surgery.
|
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 |
|---|---|---|
|
Incidence of Serious Adverse Events
時間枠：Up to 12 months post-transplant
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Incidence of serious adverse events (SAEs) at 12 months post-transplant
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Up to 12 months post-transplant
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline in Left Ventricular Ejection Fraction by Cardiac MRI
時間枠：Baseline, 6 months, and 12 months
|
Change from baseline in left ventricular ejection fraction (LVEF, %) assessed by cardiac magnetic resonance imaging (MRI).
Echocardiogram may be used as an alternative if cardiac MRI is not medically appropriate or per institutional practice.
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Baseline, 6 months, and 12 months
|
|
Change From Baseline in Left Ventricular End-Diastolic Volume by Cardiac MRI
時間枠：Baseline, 6 months, and 12 months
|
Change from baseline in left ventricular end-diastolic volume (LVEDV, mL) assessed by cardiac MRI.
Echocardiogram may be used as an alternative if cardiac MRI is not medically appropriate or per institutional practice.
|
Baseline, 6 months, and 12 months
|
|
Change From Baseline in Left Ventricular End-Systolic Volume by Cardiac MRI
時間枠：Baseline, 6 months, and 12 months
|
Change from baseline in left ventricular end-systolic volume (LVESV, mL) assessed by cardiac MRI.
Echocardiogram may be used as an alternative if cardiac MRI is not medically appropriate or per institutional practice.
|
Baseline, 6 months, and 12 months
|
|
Change From Baseline in Infarct Size by Cardiac MRI
時間枠：Baseline, 6 months, and 12 months
|
Change from baseline in myocardial infarct size assessed by cardiac MRI.
|
Baseline, 6 months, and 12 months
|
|
Change From Baseline in Myocardial Tissue Perfusion by PET/CT or SPECT
時間枠：Baseline, 6 months, and 12 months
|
Change from baseline in myocardial tissue perfusion assessed by positron emission tomography/computed tomography (PET/CT) or single-photon emission computed tomography (SPECT).
|
Baseline, 6 months, and 12 months
|
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Incidence of Major Adverse Cardiac Events
時間枠：Up to 12 months post-transplant
|
Incidence of major adverse cardiac events (MACE) during the study follow-up period.
|
Up to 12 months post-transplant
|
|
Change From Baseline in 6-Minute Walk Distance
時間枠：Baseline, 6 months, and 12 months
|
Change from baseline in exercise capacity as assessed by the 6-minute walk distance (6MWD).
The 6-Minute Walk Distance is measured as the distance walked in 6 minutes, with longer distances reflecting better functional exercise capacity.
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Baseline, 6 months, and 12 months
|
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Change From Baseline in New York Heart Association Functional Classification
時間枠：Baseline, 6 months, and 12 months
|
Change from baseline in New York Heart Association (NYHA) functional classification.
The New York Heart Association Functional Classification ranges from Class I to Class IV, with higher classes reflecting more severe limitation of physical activity and worse heart failure symptoms.
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Baseline, 6 months, and 12 months
|
|
Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score
時間枠：Baseline, 6 months, and 12 months
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Change from baseline in quality of life as measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ).
The Minnesota Living With Heart Failure Questionnaire score ranges from 0 to 105, with higher scores reflecting worse heart failure-related quality of life.
|
Baseline, 6 months, and 12 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
本研究に関する用語
キーワード
その他の研究ID番号
- HICM188H1101
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