Heart FailurePhase 1/2NCT06866600
IPSC-CMs Combined with LVAD or CABG for the Treatment of Heart Failure
A Phase 1/2 study testing low dose CABG+iPSC-CMs, High dose CABG/LVAD+iPSC-CMs and CABG/LVAD+Saline in people with Heart Failure and Heart Failure At NYHA Stage III or IV, run by HELP Therapeutics Co., Ltd. at 1 site in China.
Trial summary
This clinical trial investigates the safety, feasibility, and therapeutic potential of a combined approach using HiCM-188 cardiomyocyte injection delivered intramyocardially alongside either LVAD implantation or CABG surgery in patients with advanced ischemic heart failure. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Heart Failure, Heart Failure At NYHA Stage III or IV
- What is being tested?
- low dose CABG+iPSC-CMs, High dose CABG/LVAD+iPSC-CMs and CABG/LVAD+Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Mar 2025to Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 35-75 years (inclusive) at the time of signing the informed consent form.
- Capable of understanding the informed consent form, voluntarily agreeing to participate in the trial, and signing the informed consent form.
- Diagnosed with end-stage heart failure.
- Receiving optimized medical therapy for heart failure, with New York Heart Association (NYHA) functional class III-IV.
- Echocardiography demonstrating regional hypokinesia or akinesia of the ventricular wall.
- Cardiac magnetic resonance imaging (MRI) confirming left ventricular ejection fraction (LVEF) ≤35%.
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- Myocardial perfusion-metabolism imaging with radionuclide indicating infarcted myocardium in the left anterior descending (LAD) artery territory.
- Meets criteria for coronary artery bypass grafting (CABG) under cardiopulmonary bypass during screening and requires CABG surgery.
- For patients enrolled in the LVAD implantation group, the following additional criteria must be met:
- Definitive indication for LVAD implantation due to end-stage heart failure.
- Anticipated significant improvement in hemodynamic stability post-LVAD implantation, with potential for further cardiac functional improvement via myocardial cell injection.
- Absence of significant contraindications for LVAD surgery.
Who cannot join
- History of pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT).
- Severe valvular heart disease.
- Acute myocardial infarction or history of percutaneous coronary intervention (PCI) within 1 month prior to screening.
- Non-ischemic cardiomyopathy or acute viral myocarditis.
- Acute cerebrovascular event within 1 month prior to screening.
- History of malignancy within 5 years prior to screening.
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- Autoimmune disease or chronic use of immunosuppressive agents.
- History of organ transplantation.
- Planned concurrent major surgery (excluding left ventricular aneurysm resection or left atrial appendage closure/resection).
- Malignant ventricular arrhythmia.
- Contraindications for CABG surgery.
- Positive serology for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or Treponema pallidum antibody.
- Inability to undergo cardiac MRI or PET/CT imaging.
- Contraindications to immunosuppressive therapy or inability to comply with the protocol-specified immunosuppressive regimen.
- Hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil, tacrolimus, macrolides, prednisone acetate/methylprednisolone, other corticosteroids, or basiliximab.
- Participation in another clinical trial within 3 months prior to screening.
- Pregnancy, lactation, or positive pregnancy test in female patients.
- Any other condition deemed by the investigator to render the patient unsuitable for trial participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
HelpThera
Nanjing, Jiangsu, 210000
Jiaxian Wang, MD, PhD, +86-18565616060, wangjx@helpsci.com.cn
About this study
Official title: Study on the Safety and Efficacy of Human IPSC-Derived Cardiomyocytes in the Treatment of End-Stage Heart Failure
This clinical trial investigates the safety, feasibility, and therapeutic potential of a combined approach using HiCM-188 cardiomyocyte injection delivered intramyocardially alongside either LVAD implantation or CABG surgery in patients with advanced ischemic heart failure.
- Being tested
- low dose CABG+iPSC-CMs, High dose CABG/LVAD+iPSC-CMs, CABG/LVAD+Saline
- Keywords
- LVAD, CABG, iPSC-CMs
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low dose CABG+iPSC-CMsBiological
CABG+0.5×10^8 iPSC-CMs
High dose CABG/LVAD+iPSC-CMsBiological
CABG+1.5×10^8 iPSC-CMs or LVAD+1.5×10^8 iPSC-CMs
CABG/LVAD+SalineOther
CABG/LVAD+Saline
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | CABG combined with saline or LVAD combined with saline Receives: Other: CABG/LVAD+Saline |
| Low Dose Group | Experimental | CABG combined with 0.5×10^8 iPSC-CMs Receives: Biological: low dose CABG+iPSC-CMs |
| High dose group | Experimental | CABG combined with 1.5×10^8 iPSC-CMs or LVAD combined with 1.5×10^8 iPSC-CMs Receives: Biological: High dose CABG/LVAD+iPSC-CMs |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test
Measured: baseline, 1, 3, 6, 12 months post-operation
Major Adverse Cardiovascular Events
The composite endpoint events occurring during the prescribed postoperative follow-up period included cardiac death, non-fatal myocardial infarction, non-fatal stroke, and emergency target vessel revascularization (e.g., PCI or CABG), which was expressed as the percentage of subjects experiencing at least one of these events (%).
Measured: From enrollment to the end of study at 12 months
Survival rate
Measured: From enrollment to the end of study at 12 months
Secondary outcomes (6)
Left ventricular ejection fraction
Improvement of left ventricular ejection fraction assessed by ECHO
Measured: baseline, 1, 3, 6, 12 months post-operation
Cardiac magnetic resonance detection index
Myocardial infarction size and Myocardial fibrosis assessed by MRI
Measured: baseline, 1, 3, 6, 12 months post-operation
BNP
BNP levels are measured by venous blood samples
Measured: baseline, 1, 3, 6, 12 months post-operation
SF-36
life quality assessed by SF-36 (The Short-Form-36 Health Survey). The SF-36 scale is a tool used to assess health-related quality of life, including eight dimensions: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH). Each dimension has its unique scoring criteria, and the score range for each dimension is from 0 to 100 points. Higher scores indicate better health outcomes
Measured: baseline, 1, 3, 6, 12 months post-operation
KCCQ
Kansas City Cardiomyopathy Questionnaire, KCCQ is designed to assess the health status and quality of life of patients with heart failure. The score range is from 0 to 100 and higher scores reflect better health status and quality of life.
Measured: baseline, 1, 3, 6, 12 months post-operation
Removal rate of LVAD
Percentage of subjects who had their Left Ventricular Assist Device (LVAD) successfully removed after surgery
Measured: From enrollment to the end of study at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HELP Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yongfeng Shao, MD, PhD, Principal investigator, Jiangsu Provincial People's Hospital (First Affiliated Hospital of Nanjing Medical University)Liansheng Wang, MD, PhD, Principal investigator, Jiangsu Provincial People's Hospital (First Affiliated Hospital of Nanjing Medical University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866600
- Sponsor's protocol ID
- SYF, WLS
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Safety and Efficacy of Human IPSC-Derived Cardiomyocytes in the Treatment of End-Stage Heart Failure
- ClinicalTrials.gov ID
- NCT06866600
- Acronym / sponsor ID
- SYF, WLS
- Keywords
- LVAD, CABG, iPSC-CMs
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- HELP Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial investigates the safety, feasibility, and therapeutic potential of a combined approach using HiCM-188 cardiomyocyte injection delivered intramyocardially alongside either LVAD implantation or CABG surgery in patients with advanced ischemic heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Other: CABG/LVAD+SalineCABG combined with saline or LVAD combined with saline |
| Low Dose Group | Experimental | Biological: low dose CABG+iPSC-CMsCABG combined with 0.5×10^8 iPSC-CMs |
| High dose group | Experimental | Biological: High dose CABG/LVAD+iPSC-CMsCABG combined with 1.5×10^8 iPSC-CMs or LVAD combined with 1.5×10^8 iPSC-CMs |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female aged 35-75 years (inclusive) at the time of signing the informed consent form.
- Capable of understanding the informed consent form, voluntarily agreeing to participate in the trial, and signing the informed consent form.
- Diagnosed with end-stage heart failure.
- Receiving optimized medical therapy for heart failure, with New York Heart Association (NYHA) functional class III-IV.
- Echocardiography demonstrating regional hypokinesia or akinesia of the ventricular wall.
Key exclusion criteria (18 listed)
- History of pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT).
- Severe valvular heart disease.
- Acute myocardial infarction or history of percutaneous coronary intervention (PCI) within 1 month prior to screening.
- Non-ischemic cardiomyopathy or acute viral myocarditis.
- Acute cerebrovascular event within 1 month prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low dose CABG+iPSC-CMsCABG+0.5×10^8 iPSC-CMs | Biological | Low Dose Group |
| High dose CABG/LVAD+iPSC-CMsCABG+1.5×10^8 iPSC-CMs or LVAD+1.5×10^8 iPSC-CMs | Biological | High dose group |
| CABG/LVAD+SalineCABG/LVAD+Saline | Other | Control group |
Primary outcome
6-minute walk test
Time frame: baseline, 1, 3, 6, 12 months post-operation
Major Adverse Cardiovascular Events
Time frame: From enrollment to the end of study at 12 months
The composite endpoint events occurring during the prescribed postoperative follow-up period included cardiac death, non-fatal myocardial infarction, non-fatal stroke, and emergency target vessel revascularization (e.g., PCI or CABG), which was expressed as the percentage of subjects experiencing at least one of these events (%).
Survival rate
Time frame: From enrollment to the end of study at 12 months
6 secondary outcomes
Left ventricular ejection fraction
Time frame: baseline, 1, 3, 6, 12 months post-operation
Cardiac magnetic resonance detection index
Time frame: baseline, 1, 3, 6, 12 months post-operation
BNP
Time frame: baseline, 1, 3, 6, 12 months post-operation
SF-36
Time frame: baseline, 1, 3, 6, 12 months post-operation
KCCQ
Time frame: baseline, 1, 3, 6, 12 months post-operation
Removal rate of LVAD
Time frame: From enrollment to the end of study at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yongfeng Shao, MD, PhD principal investigator
Jiangsu Provincial People's Hospital (First Affiliated Hospital of Nanjing Medical University)
Liansheng Wang, MD, PhD principal investigator
Jiangsu Provincial People's Hospital (First Affiliated Hospital of Nanjing Medical University)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing low dose CABG+iPSC-CMs, High dose CABG/LVAD+iPSC-CMs and CABG/LVAD+Saline in people with Heart Failure and Heart Failure At NYHA Stage III or IV, run by HELP Therapeutics Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiaxian Wang, MD, PhD (+86-18565616060, wangjx@helpsci.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk test (time frame: baseline, 1, 3, 6, 12 months post-operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.