Heart FailurePhase 3REVIVE-HEARTNCT07496372
A Pivotal Clinical Trial of Human Induced Pluripotent Stem Cell-derived Cardiomyocytes Injection (HiCM-188) for the Treatment of Advanced Heart Failure(NYHA III-IV)
A Phase 3 study testing HiCM-188 therapy and CABG surgery in people with Heart Failure, run by HELP Therapeutics Co., Ltd. at 1 site in China.
Trial summary
The purpose of this clinical study is to evaluate the efficacy and safety of intramyocardial injection of human induced pluripotent stem cell-derived cardiomyocyte injection (HiCM-188) in patients with advanced heart failure (NYHA Class III-IV) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- HiCM-188 therapy and CABG surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2026to 31 Aug 2027
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years, regardless of gender;
- Patients with ischemic heart failure with NYHA functional class III or IV after receiving the maximum tolerated dose of guideline-directed medical therapy (GDMT);
- LVEF ≤ 35% as measured by cardiac MRI;
- Coronary angiography meeting the indications for coronary artery bypass grafting (CABG) surgery;
- Voluntary participation and signing of the informed consent form.
Who cannot join
- Patients considered for this trial must not meet any of the following criteria:
- Acute viral myocarditis;
- Acute phase of myocardial infarction (≤ 3 months);
- Cardiac amyloidosis;
- Pericarditis;
- Expected to undergo heart transplantation;
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- Suffering from a disease that restricts the motor system, making them unable to complete the 6-minute walk test;
- Suffering from autoimmune diseases;
- Estimated glomerular filtration rate (eGFR) < 35 ml/min/1.73m², or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 100 U/L;
- Presence of any untreated precancerous lesions or those requiring active monitoring;
- Occurrence of malignant tumors within 5 years prior to screening;
- Expected to undergo other concurrent cardiac surgeries (excluding ventricular aneurysm resection and left atrial appendage excision/ligation);
- Having contraindications to the use of immunosuppressants;
- Having contraindications to MRI;
- Having contraindications to CABG surgery;
- Females who are pregnant, lactating, or have a positive blood pregnancy test;
- Plans to conceive within one year;
- Having systemic diseases that are not effectively controlled;
- Other conditions deemed unsuitable for participation in this clinical trial as evaluated by the investigator.
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, 1 recruiting
- Recruiting
TEDA International Cardiovascular Hospital
Tianjin, Tianjin Municipality, 300457
Xiaocheng Liu, +86-022-65208030, liuxc@tedaich.com
About this study
Official title: A Pivotal Multicenter, Randomized, Controlled Trial to Evaluate the Efficacy and Safety of Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) for the Treatment of Advanced Heart Failure(NYHA III-IV)
The purpose of this clinical study is to evaluate the efficacy and safety of intramyocardial injection of human induced pluripotent stem cell-derived cardiomyocyte injection (HiCM-188) in patients with advanced heart failure (NYHA Class III-IV)
Read the detailed description
REVIVE-HEART is a multicenter, randomized, controlled, confirmatory clinical trial evaluating patients with advanced heart failure (NYHA III-IV). Participants were assigned to receive either conventional coronary artery bypass grafting (CABG) alone or CABG combined with HiCM-188 (150 million cells). The cells were administered via myocardial injections around the infarcted area, followed by postoperative immunosuppressive therapy. Efficacy and safety were assessed 12 months post-treatment.
- Conditions
- Heart Failure
- Being tested
- HiCM-188 therapy, CABG surgery
- Keywords
- Advanced heart failure, HiCM188, HiCM-188, REVIVE-HEART, cardiomyocyte
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HiCM-188 therapyBiological
Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) during coronary artery bypass grafting surgery
CABG surgeryProcedure or surgery
Conventional coronary artery bypass grafting (CABG) surgery
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Coronary artery bypass grafting surgery Receives: Procedure: CABG surgery |
| Experimental group | Experimental | Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) during coronary artery bypass grafting surgery Receives: Biological: HiCM-188 therapy; Procedure: CABG surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk distance (6MWD)
Measured: 12 months after surgery
Secondary outcomes (14)
All-cause mortality and cardiovascular mortality
Measured: 12 months after surgery
6MWD
Measured: 6 months after surgery
Change from baseline in the NYHA classification
Measured: 12 months after surgery
Worsening heart failure (including events requiring hospitalization or emergency treatment due to worsening symptoms and signs of heart failure)
Measured: 12 months after surgery
Change from baseline in the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
The MLHFQ is a self-administered disease-specific outcome measure instrument for patients with heart failure (HF), comprising 21 items rated on Likert scales, representing different degrees of impact of HF on QoL. The MLHFQ scores are on a range of 0-105, in which lower scores reflect better health status.
Measured: 12 months after surgery
Change from baseline in the SF-36 questionnaire
The 36-Item Short Form Survey(SF-36) is a self-administered outcome measure instrument that comprises 36 items grouped into 8 dimensions: limitations in physical activities because of health problems, limitations in social activities because of physical or emotional problems, limitations in usual role activities because of physical health problems, bodily pain, general mental health, limitations in usual role activities because of emotional problems, vitality, general health perceptions. The SF-36 scores are on a range of 0-100, in which higher scores reflect better health status.
Measured: 12 months after surgery
Myocardial blood flow as assessed by SPECT
Measured: 12 months after surgery
Myocardial viability as assessed by SPECT
Measured: 12 months after surgery
Left ventricular ejection fraction as assessed by MRI
Left ventricular ejection fraction
Measured: 12 months after surgery
Cardiac Volumes as assessed by MRI
Left ventricular end-diastolic volume index (LVEDVi), Left ventricular end-systolic volume index (LVESVi) and Stroke Volume (SV)
Measured: 12 months after surgery
Scar size as assessed by MRI
Measured: 12 months after surgery
Change from baseline in NT-proBNP level
Measured: 12 months after surgery
Tumor markers abnormally elevated compared to baseline
Measured: 12 months after surgery
Other AEs
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start30 Apr 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Aug 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HELP Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496372
- Sponsor's protocol ID
- Liu XC
- Acronym
- REVIVE-HEART
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Multicenter, Randomized, Controlled Trial to Evaluate the Efficacy and Safety of Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) for the Treatment of Advanced Heart Failure(NYHA III-IV)
- ClinicalTrials.gov ID
- NCT07496372
- Acronym / sponsor ID
- REVIVE-HEART / Liu XC
- Conditions
- Heart Failure
- Keywords
- Advanced heart failure, HiCM188, HiCM-188, REVIVE-HEART, cardiomyocyte
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- HELP Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 27 Mar 2026 (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.
The purpose of this clinical study is to evaluate the efficacy and safety of intramyocardial injection of human induced pluripotent stem cell-derived cardiomyocyte injection (HiCM-188) in patients with advanced heart failure (NYHA Class III-IV)
Detailed description
REVIVE-HEART is a multicenter, randomized, controlled, confirmatory clinical trial evaluating patients with advanced heart failure (NYHA III-IV). Participants were assigned to receive either conventional coronary artery bypass grafting (CABG) alone or CABG combined with HiCM-188 (150 million cells). The cells were administered via myocardial injections around the infarcted area, followed by postoperative immunosuppressive therapy. Efficacy and safety were assessed 12 months post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: CABG surgeryCoronary artery bypass grafting surgery |
| Experimental group | Experimental | Biological: HiCM-188 therapy, Procedure: CABG surgeryIntramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) during coronary artery bypass grafting surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 to 75 years, regardless of gender;
- Patients with ischemic heart failure with NYHA functional class III or IV after receiving the maximum tolerated dose of guideline-directed medical therapy (GDMT);
- LVEF ≤ 35% as measured by cardiac MRI;
- Coronary angiography meeting the indications for coronary artery bypass grafting (CABG) surgery;
- Voluntary participation and signing of the informed consent form.
Key exclusion criteria (19 listed)
- Acute viral myocarditis;
- Acute phase of myocardial infarction (≤ 3 months);
- Cardiac amyloidosis;
- Pericarditis;
- Expected to undergo heart transplantation;
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 |
|---|---|---|
| HiCM-188 therapyIntramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) during coronary artery bypass grafting surgery | Biological | Experimental group |
| CABG surgeryConventional coronary artery bypass grafting (CABG) surgery | Procedure or surgery | Control group, Experimental group |
Primary outcome
6-minute walk distance (6MWD)
Time frame: 12 months after surgery
14 secondary outcomes
All-cause mortality and cardiovascular mortality
Time frame: 12 months after surgery
6MWD
Time frame: 6 months after surgery
Change from baseline in the NYHA classification
Time frame: 12 months after surgery
Worsening heart failure (including events requiring hospitalization or emergency treatment due to worsening symptoms and signs of heart failure)
Time frame: 12 months after surgery
Change from baseline in the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Time frame: 12 months after surgery
Change from baseline in the SF-36 questionnaire
Time frame: 12 months after surgery
Myocardial blood flow as assessed by SPECT
Time frame: 12 months after surgery
Myocardial viability as assessed by SPECT
Time frame: 12 months after surgery
Left ventricular ejection fraction as assessed by MRI
Time frame: 12 months after surgery
Cardiac Volumes as assessed by MRI
Time frame: 12 months after surgery
Scar size as assessed by MRI
Time frame: 12 months after surgery
Change from baseline in NT-proBNP level
Time frame: 12 months after surgery
Tumor markers abnormally elevated compared to baseline
Time frame: 12 months after surgery
Other AEs
Time frame: 12 months after surgery
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 12 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HiCM-188 therapy and CABG surgery in people with Heart Failure, 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 5 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 12 May 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk distance (6MWD) (time frame: 12 months after surgery). 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 12 May 2026.