Ischemic Heart FailurePhase 1/2NCT07471698
hiPSC-CMs-loaded Chitosan Patch to Treat Severe Chronic Ischemic Heart Disease
A Phase 1/2 study testing HiCM-188 Chitosan Patch and Blank Chitosan Patch in people with Ischemic Heart Failure and CABG-patients, run by HELP Therapeutics Co., Ltd. at 1 site in China.
Trial summary
This is an exploratory study. A total of 16 patients meeting the inclusion and exclusion criteria and awaiting coronary artery bypass grafting (CABG) surgery will be enrolled. After providing informed consent, participants will be randomized 1:1 under double-blind conditions into two groups: 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Heart Failure, CABG-patients
- What is being tested?
- HiCM-188 Chitosan Patch and Blank Chitosan Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2026to 20 Oct 2028
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years (inclusive).
- Willingness and ability to give written informed consent.
- Chronic left ventricular dysfunction classified as Stage D (refractory end-stage heart failure) according to ACC staging criteria.
- NYHA functional class III-IV despite optimized guideline-directed medical therapy for heart failure.
- Indication for coronary artery bypass grafting (CABG), meeting one of the following anatomical criteria:
- 5.1 Class I Indications :
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- Left ventricular dysfunction with significant left main coronary artery disease;
- Left ventricular dysfunction with "left main equivalent" disease (i.e., ≥70% stenosis in proximal LAD or proximal LCx);
- Left ventricular dysfunction with two- or three-vessel disease including proximal LAD stenosis.
- 5.2 Class IIa Indication : Left ventricular dysfunction with substantial viable, akinetic but revascularizable myocardium, not covered by above Class I anatomical criteria.
- Left ventricular ejection fraction (LVEF) ≤40% as measured by echocardiography or cardiac MRI within 6 months prior to enrollment (excluding measurements obtained within 1 month post-myocardial infarction).
- Echocardiographic evidence of regional wall motion abnormalities (hypokinesis, akinesis, or presence of ventricular aneurysm).
Who cannot join
- Patients meeting any of the following criteria are ineligible for study participation:
- History of permanent pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device implantation.
- Severe valvular heart disease or prior prosthetic valve replacement.
- Prior percutaneous coronary intervention (PCI) with stent implantation.
- Chronic atrial fibrillation.
- History of sustained ventricular tachycardia or aborted sudden cardiac death.
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- Baseline estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m².
- Hematocrit <25%.
- Severe contrast media allergy (anaphylactic or life-threatening reaction history).
- Coagulation disorder (INR >1.5 without therapeutic anticoagulation, platelets <50×10⁹/L, or clinically significant bleeding diathesis).
- Known hypersensitivity to penicillin or streptomycin.
- Contraindication to undergoing cardiac MRI (e.g., incompatible implanted devices, severe claustrophobia unresponsive to premedication).
- History of solid organ or bone marrow transplantation.
- Active malignancy or history of cancer within the past 5 years (except non-melanoma skin cancer or carcinoma in situ).
- Life expectancy <1 year due to non-cardiac conditions.
- Long-term systemic immunosuppressive therapy (e.g., corticosteroids, TNF-α inhibitors).
- Contraindications to immunosuppressive therapy (e.g., active infection, uncontrolled diabetes, peptic ulcer disease).
- Active infectious diseases: HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis (Treponema pallidum, TP).
- Currently participating in another interventional clinical trial.
- Pregnant or lactating women.
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
The Second Xiangya Hospital of Central South University
Changsha
Xiaobo Liao, MD, PhD
Chengming Fan, MD, PhD
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Human Induce Pluripotent Stem Cell-derived Cardiomyocytes(HiCM-188) -Loaded Chitosan Patch to Treat Severe Chronic Ischemic Heart Disease
This is an exploratory study. A total of 16 patients meeting the inclusion and exclusion criteria and awaiting coronary artery bypass grafting (CABG) surgery will be enrolled. After providing informed consent, participants will be randomized 1:1 under double-blind conditions into two groups:
- CABG + HiCM-188-loaded chitosan patch group (patch size: 2×4 cm; containing 5 million cells per patch)
- CABG + blank chitosan patch group (identical in appearance but without HiCM-188 cells).
During CABG surgery, investigators will apply two HiCM-188-loaded chitosan patches onto the epicardial surface over regions of hypokinetic myocardium. The total transplanted cell dose per patient in the treatment group is 1 × 10⁷ . In the control group, eight patients will undergo identical surgical procedures with application of chitosan patches without HiCM-188 cells.
- Conditions
- Ischemic Heart Failure, CABG-patients
- Being tested
- HiCM-188 Chitosan Patch, Blank Chitosan Patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HiCM-188 Chitosan PatchDrug
Patients receive standard coronary artery bypass grafting (CABG) surgery plus epicardial application of two chitosan patches (each 2×4 cm in size, loaded with 5 million HiCM-188 cells), delivering a total dose of 1 × 10⁷ cardiomyocytes.
Blank Chitosan PatchDrug
Patients receive standard CABG surgery plus epicardial application of two identical-appearing chitosan patches containing no HiCM-188 cells
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Not described Receives: Drug: Blank Chitosan Patch |
| Treatment | Experimental | Not described Receives: Drug: HiCM-188 Chitosan Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion and frequency of patients experiencing sustained ventricular tachycardia lasting more than 30 seconds
Measured: 1~6 Month Post-operation
Incidence of allogeneic human-derived tumor formation
CT scan of the abdomen and pelvis
Measured: Baseline, 1, 3, 6 months post-operation
Secondary outcomes (11)
Change in infarct size
Assessed by MRI
Measured: Baseline, 1, 3, 6, and 12 months post-operation
Change in regional left ventricular function
Assessed by MRI
Measured: Baseline, 1, 3, 6, and 12 months post-operation
Change in regional left ventricular wall thickness
Assessed by MRI
Measured: Baseline, 1, 3, 6, and 12 months post-operation
Change in left ventricular end-diastolic wall thickness
Assessed by both MRI and echocardiography
Measured: Baseline, 1, 3, 6, and 12 months post-operation
Change in left ventricular ejection fraction (LVEF)
Assessed by both MRI and echocardiography
Measured: Baseline, 1, 3, 6, and 12 months post-operation
Change in left ventricular end-diastolic volume (LVEDV)
Assessed by both MRI and echocardiography
Measured: Baseline, 1, 3, 6, and 12 months post-operation
Change in left ventricular end-systolic volume (LVESV)
Assessed by both MRI and echocardiography
Measured: Baseline, 1, 3, 6, and 12 months post-operation
Change in regional myocardial perfusion
Assessed by MRI
Measured: Baseline, 1, 3, 6, and 12 months post-operation
Six-minute walk test
The distance a participant can walk on a flat, hard surface in 6 minutes
Measured: Baseline, 1, 3, 6, and 12 months post-operation
New York Heart Association (NYHA) functional classification
A clinician-assessed 4-class scale (I-IV) evaluating symptom severity and functional limitation due to heart failure. Higher classes indicate greater impairment in physical activity tolerance.
Measured: Baseline, 1, 3, 6, and 12 months post-operation
Minnesota Living with Heart Failure Questionnaire (MLHFQ) score
A 21-item patient-reported outcome measure assessing health-related quality of life specific to heart failure. Total score ranges from 0 (no impact) to 105 (severe impact). Lower scores reflect better quality of life.
Measured: Baseline, 1, 3, 6, and 12 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start20 Oct 2026 (estimated)
- Primary completion20 Oct 2028 (estimated)
- Study completion20 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HELP Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Second Xiangya Hospital of Central South University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471698
- Sponsor's protocol ID
- LXB
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Human Induce Pluripotent Stem Cell-derived Cardiomyocytes(HiCM-188) -Loaded Chitosan Patch to Treat Severe Chronic Ischemic Heart Disease
- ClinicalTrials.gov ID
- NCT07471698
- Acronym / sponsor ID
- LXB
- Conditions
- Ischemic Heart Failure, CABG-patients
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- HELP Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Second Xiangya Hospital of Central South University
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 20 Oct 2028 (estimated)
- Study completion
- 20 Oct 2028 (estimated)
- First posted
- 13 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.
This is an exploratory study. A total of 16 patients meeting the inclusion and exclusion criteria and awaiting coronary artery bypass grafting (CABG) surgery will be enrolled. After providing informed consent, participants will be randomized 1:1 under double-blind conditions into two groups:
- CABG + HiCM-188-loaded chitosan patch group (patch size: 2×4 cm; containing 5 million cells per patch)
- CABG + blank chitosan patch group (identical in appearance but without HiCM-188 cells).
During CABG surgery, investigators will apply two HiCM-188-loaded chitosan patches onto the epicardial surface over regions of hypokinetic myocardium. The total transplanted cell dose per patient in the treatment group is 1 × 10⁷ . In the control group, eight patients will undergo identical surgical procedures with application of chitosan patches without HiCM-188 cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Blank Chitosan Patch |
| Treatment | Experimental | Drug: HiCM-188 Chitosan Patch |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age between 18 and 80 years (inclusive).
- Willingness and ability to give written informed consent.
- Chronic left ventricular dysfunction classified as Stage D (refractory end-stage heart failure) according to ACC staging criteria.
- NYHA functional class III-IV despite optimized guideline-directed medical therapy for heart failure.
- Indication for coronary artery bypass grafting (CABG), meeting one of the following anatomical criteria:
Key exclusion criteria (20 listed)
- History of permanent pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device implantation.
- Severe valvular heart disease or prior prosthetic valve replacement.
- Prior percutaneous coronary intervention (PCI) with stent implantation.
- Chronic atrial fibrillation.
- History of sustained ventricular tachycardia or aborted sudden cardiac death.
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 Chitosan PatchPatients receive standard coronary artery bypass grafting (CABG) surgery plus epicardial application of two chitosan patches (each 2×4 cm in size, loaded with 5 million HiCM-188 cells), delivering a total dose of 1 × 10⁷ cardiomyocytes. | Drug | Treatment |
| Blank Chitosan PatchPatients receive standard CABG surgery plus epicardial application of two identical-appearing chitosan patches containing no HiCM-188 cells | Drug | Control |
Primary outcome
Proportion and frequency of patients experiencing sustained ventricular tachycardia lasting more than 30 seconds
Time frame: 1~6 Month Post-operation
Incidence of allogeneic human-derived tumor formation
Time frame: Baseline, 1, 3, 6 months post-operation
CT scan of the abdomen and pelvis
11 secondary outcomes
Change in infarct size
Time frame: Baseline, 1, 3, 6, and 12 months post-operation
Change in regional left ventricular function
Time frame: Baseline, 1, 3, 6, and 12 months post-operation
Change in regional left ventricular wall thickness
Time frame: Baseline, 1, 3, 6, and 12 months post-operation
Change in left ventricular end-diastolic wall thickness
Time frame: Baseline, 1, 3, 6, and 12 months post-operation
Change in left ventricular ejection fraction (LVEF)
Time frame: Baseline, 1, 3, 6, and 12 months post-operation
Change in left ventricular end-diastolic volume (LVEDV)
Time frame: Baseline, 1, 3, 6, and 12 months post-operation
Change in left ventricular end-systolic volume (LVESV)
Time frame: Baseline, 1, 3, 6, and 12 months post-operation
Change in regional myocardial perfusion
Time frame: Baseline, 1, 3, 6, and 12 months post-operation
Six-minute walk test
Time frame: Baseline, 1, 3, 6, and 12 months post-operation
New York Heart Association (NYHA) functional classification
Time frame: Baseline, 1, 3, 6, and 12 months post-operation
Minnesota Living with Heart Failure Questionnaire (MLHFQ) score
Time frame: Baseline, 1, 3, 6, and 12 months post-operation
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 13 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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 1/2 study testing HiCM-188 Chitosan Patch and Blank Chitosan Patch in people with Ischemic Heart Failure and CABG-patients, 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 20 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 13 Mar 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. 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?
Proportion and frequency of patients experiencing sustained ventricular tachycardia lasting more than 30 seconds (time frame: 1~6 Month Post-operation). The study lists 2 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 13 Mar 2026.