Multicenter, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart Failure (NYHA Class III-IV)

Plain English Summary

Efficacy and Safety of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart Failure (NYHA Class III-IV) is a Phase 3 clinical trial sponsored by HELP Therapeutics Co., Ltd. studying Heart Failure. Tests the safety and effectiveness of HiCM-188, a stem cell therapy, in advanced heart failure patients. For patients with severe heart failure (NYHA Class III-IV) who have tried all other treatments. Participation involves a stem cell injection during heart surgery and regular follow-ups. Alternative treatments include standard heart failure medications and surgical options like CABG. The trial aims to enroll 80 participants.

Official 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)

Who Can Participate

Here is what you need to know about eligibility for this trial. Ages 18-75, both genders, with severe heart failure and low heart function (LVEF ≤ 35%). Excluded if had recent heart attack, certain cancers, kidney issues, or other serious health problems. This trial is studying Heart Failure, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures the distance patients can walk in 6 minutes after the treatment, indicating improved heart function. The specific primary outcome measures are: 6-minute walk distance (6MWD) (12 months after surgery). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial aims to fill a gap in treatment options for advanced heart failure patients who have exhausted other therapies. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Heart Failure, where improved treatment options are needed.

Investor Insight

Market size for advanced heart failure treatments is large, with few approved stem cell therapies, making this trial significant. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor about your heart function and if you're a good candidate for this trial. Participation involves a stem cell injection during heart surgery and regular check-ups. The trial is being conducted at multiple sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: SINGLE
• Enrollment: 80 participants

Interventions

• BIOLOGICAL: HiCM-188 therapy — Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) during coronary artery bypass grafting surgery
• PROCEDURE: CABG surgery — Conventional coronary artery bypass grafting (CABG) surgery

Primary Outcomes

• 6-minute walk distance (6MWD) (12 months after surgery)

Secondary Outcomes

• All-cause mortality and cardiovascular mortality (12 months after surgery)
• 6MWD (6 months after surgery)
• Change from baseline in the NYHA classification (12 months after surgery)
• Worsening heart failure (including events requiring hospitalization or emergency treatment due to worsening symptoms and signs of heart failure) (12 months after surgery)
• Change from baseline in the Minnesota Living with Heart Failure Questionnaire (MLHFQ) (12 months after surgery)

Full Eligibility Criteria

Inclusion Criteria:

1. Aged 18 to 75 years, regardless of gender;
2. Patients with ischemic heart failure with NYHA functional class III or IV after receiving the maximum tolerated dose of guideline-directed medical therapy (GDMT);
3. LVEF ≤ 35% as measured by cardiac MRI;
4. Coronary angiography meeting the indications for coronary artery bypass grafting (CABG) surgery;
5. Voluntary participation and signing of the informed consent form.

Exclusion Criteria:

Patients considered for this trial must not meet any of the following criteria:

1. Acute viral myocarditis;
2. Acute phase of myocardial infarction (≤ 3 months);
3. Cardiac amyloidosis;
4. Pericarditis;
5. Expected to undergo heart transplantation;
6. Suffering from a disease that restricts the motor system, making them unable to complete the 6-minute walk test;
7. Suffering from autoimmune diseases;
8. Estimated glomerular filtration rate (eGFR) \< 35 ml/min/1.73m², or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 100 U/L;
9. Presence of any untreated precancerous lesions or those requiring active monitoring;
10. Occurrence of malignant tumors within 5 years prior to screening;
11. Expected to undergo other concurrent cardiac surgeries (excluding ventricular aneurysm resection and left atrial appendage excision/ligation);
12. Having contraindications to the use of immunosuppressants;
13. Having contraindications to MRI;
14. Having contraindications to CABG surgery;
15. Females who are pregnant, lactating, or have a positive blood pregnancy test;
16. Plans to conceive within one year;
17. Having systemic diseases that are not effectively controlled;
18. Other conditions deemed unsuitable for participation in this clinical trial as evaluated by the investigator.

Frequently Asked Questions

Related Conditions

• Conditions: Heart failure, ischemic heart failure, coronary artery disease.
• Therapeutic areas: Cardiology, regenerative medicine, heart surgery.

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