Ischemic Heart FailureEarly Phase 1NCT05566600
Allogeneic iPSC-derived Cardiomyocyte Therapy in Patients With Worsening Ischemic Heart Failure
A Early Phase 1 study testing Human (allogeneic) iPS-cell-derived cardiomyocyte in people with Ischemic Heart Failure and Chronic Heart Failure, run by HELP Therapeutics Co., Ltd. at 2 sites in China.
Trial summary
This study is designed to evaluate the safety and efficacy of allogeneic induced pluripotent cell derived cardiomyocytes (iPSC-CMs) in treating patients with worsening ischemic heart failure undergoing coronary artery bypass graft surgery. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Ischemic Heart Failure, Chronic Heart Failure
- What is being tested?
- Human (allogeneic) iPS-cell-derived cardiomyocyte
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesChina
- Study dates
- 9 Oct 2022to 31 Jul 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- Aged 35-75 (including 35 and 75).
- Signed the Informed Consent Form (ICF).
- Have chronic left ventricular dysfunction.
- Have NYHA Class III-IV cardiac function even after improved medication for the treatment of advanced chronic heart failure.
- Have indications for Coronary Artery Bypass Grafting.
- LVEF < 40% as determined by echocardiogram (data collected up to 6 months prior to inclusion evaluation are valid; data collected within 1 month since a myocardial infarction are invalid).
- Weakening or absence of segmental regional wall motion as determined by standard imaging
Who cannot join
- PRA ≥ 20% or DSA-positive
- Patient received ICD transplantation, CRT or similar treatment.
- Patients with valvular heart disease or received heart valvular disease
- Patients received treatment of percutaneous transluminal coronary intervention (PCI)
- Patients with atrial fibrillation
- Patients previously suffered sustained ventricular tachycardia or sudden cardiac death.
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- Baseline glomerular filtration rate <30ml/min/1.73m2.
- Liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the ULN.
- Hematological abnormality: A hematocrit <25% as determined by HCT, white blood cell<2500/ul or platelet values <100000/ul without another explanation.
- Known, serious radiographic contrast allergy, penicillin allergy, streptomycin allergy.
- Coagulopathy (INR>1.3) not due to a reversible cause.
- Contra-indication to performance of a MRI scan.
- Recipients of organ transplant.
- Clinical history of malignancy within 5 years (patients with prior malignancy must be disease free for 5 years).
- Non-cardiac condition that limits lifespan <1 year.
- On chronic therapy with immunosuppressant medication, such as glucocorticoid and TNFα antagonist.
- Patients allergy to or cannot use immunosuppressant.
- Serum positive for HIV, HBV, HCV, TP.
- Currently enrolled other investigational therapeutic or device study.
- Patients who are pregnant or breast feeding.
- Other conditions that researchers consider not suitable to participate in this study.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
The second xiangya hospital of central south university
Changsha, Hunan, 410000
Chengming Fan, +86-18390945539
Jinfu Yang, MD
- Not yet recruiting
HelpThera
Nanjing, Jiangsu, 210000
Jiaxian Wang, +86-18565616060, wangjx@helptx.com.cn
About this study
Official title: Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes to Treat Severe Chronic Heart Failure
This study is designed to evaluate the safety and efficacy of allogeneic induced pluripotent cell derived cardiomyocytes (iPSC-CMs) in treating patients with worsening ischemic heart failure undergoing coronary artery bypass graft surgery.
After screening, iPSC-CMs will be administrated intramyocardially in consented and eligible patients undergoing open-chest CABG surgery and the estimated population size for the study will be 32 patients.
- Conditions
- Ischemic Heart Failure, Chronic Heart Failure
- Being tested
- Human (allogeneic) iPS-cell-derived cardiomyocyte
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human (allogeneic) iPS-cell-derived cardiomyocyteBiological
10-20 epicardial injections (0.25 mL each) of iPSC-CMs will be delivered in the border zone of the infarcted myocardium
| Study group | Role | What they receive |
|---|---|---|
| Dose level 1 | Experimental | 100 million iPSC-CMs administration Receives: Biological: Human (allogeneic) iPS-cell-derived cardiomyocyte |
| Dose level 2 | Experimental | 200 million iPSC-CMs administration Receives: Biological: Human (allogeneic) iPS-cell-derived cardiomyocyte |
| Dose level 3 | Experimental | 400 million iPSC-CMs administration Receives: Biological: Human (allogeneic) iPS-cell-derived cardiomyocyte |
| Control | No intervention | Participants will received CABG surgery only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety in terms of the incidence and severity of adverse events
Number of participants with death, fatal myocardial infarction, stroke, ventricular tachycardia sustained for >15 seconds and newly formed tumor
Measured: within 1 month post CABG surgery
Secondary outcomes (9)
Incidence of adverse events
Adverse events that require medical intervention
Measured: 1~6 months post CABG surgery
Cardiac assessment
24-hour Holter Monitoring post the CABG surgery
Measured: 1~6 months post CABG surgery
Incidence of newly formed tumor
Evaluation by chest, abdominal and pelvic CT scan and PET-CT scan
Measured: 1~12 months post CABG surgery
Immunogenic assessments
Donor specific antibody (DSA), serum anti-human leukocyte antigens (anti-HLA) antibody/panel-reactive antibody (PRA) serology monitoring
Measured: 1 month, 3 months and 6 months post CABG surgery
Changes in left ventricle function evaluation by echocardiogram (ECHO) or cardiac MRI
Changes in cardiac function will be assessed by left ventricular end-systolic volume (LVESV, mL) changes from baseline to 12 months post surgery
Measured: from baseline to 12 months at 3, 6, and 12 months post CABG surgery
Changes in 6-minute walk test (6MWT)
Measured: from baseline to 12 months at 1, 3, 6, and 12 months post CABG surgery
Changes in NYHA functional classification
Measured: from baseline to 12 months at 1, 3, 6, and 12 months post CABG surgery
Changes in quality of life (QoL)
Quality of life changes as measured by Minnesota Living with Heart Failure Questionnaire (MLHFQ) scores
Measured: from baseline to 12 months at 1, 3, 6, and 12 months post CABG surgery
Incidence of hospitalization for worsening heart failure
Measured: 1~12 months post CABG surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start9 Oct 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jul 2025 (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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HELP Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Central South University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566600
- Sponsor's protocol ID
- JFYang
- Status last verified
- Nov 2023
- First submitted
- 22 Sep 2022
- Last updated
- 22 Nov 2023
- 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 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes to Treat Severe Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT05566600
- Acronym / sponsor ID
- JFYang
- Conditions
- Ischemic Heart Failure, Chronic Heart Failure
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- HELP Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Central South University
- Study start
- 9 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 4 Oct 2022 (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 study is designed to evaluate the safety and efficacy of allogeneic induced pluripotent cell derived cardiomyocytes (iPSC-CMs) in treating patients with worsening ischemic heart failure undergoing coronary artery bypass graft surgery.
After screening, iPSC-CMs will be administrated intramyocardially in consented and eligible patients undergoing open-chest CABG surgery and the estimated population size for the study will be 32 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose level 1 | Experimental | Biological: Human (allogeneic) iPS-cell-derived cardiomyocyte100 million iPSC-CMs administration |
| Dose level 2 | Experimental | Biological: Human (allogeneic) iPS-cell-derived cardiomyocyte200 million iPSC-CMs administration |
| Dose level 3 | Experimental | Biological: Human (allogeneic) iPS-cell-derived cardiomyocyte400 million iPSC-CMs administration |
| Control | No intervention | –Participants will received CABG surgery only |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 35-75 (including 35 and 75).
- Signed the Informed Consent Form (ICF).
- Have chronic left ventricular dysfunction.
- Have NYHA Class III-IV cardiac function even after improved medication for the treatment of advanced chronic heart failure.
- Have indications for Coronary Artery Bypass Grafting.
Key exclusion criteria (21 listed)
- PRA ≥ 20% or DSA-positive
- Patient received ICD transplantation, CRT or similar treatment.
- Patients with valvular heart disease or received heart valvular disease
- Patients received treatment of percutaneous transluminal coronary intervention (PCI)
- Patients with atrial fibrillation
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 |
|---|---|---|
| Human (allogeneic) iPS-cell-derived cardiomyocyte10-20 epicardial injections (0.25 mL each) of iPSC-CMs will be delivered in the border zone of the infarcted myocardium | Biological | Dose level 1, Dose level 2, Dose level 3 |
Primary outcome
Safety in terms of the incidence and severity of adverse events
Time frame: within 1 month post CABG surgery
Number of participants with death, fatal myocardial infarction, stroke, ventricular tachycardia sustained for >15 seconds and newly formed tumor
9 secondary outcomes
Incidence of adverse events
Time frame: 1~6 months post CABG surgery
Cardiac assessment
Time frame: 1~6 months post CABG surgery
Incidence of newly formed tumor
Time frame: 1~12 months post CABG surgery
Immunogenic assessments
Time frame: 1 month, 3 months and 6 months post CABG surgery
Changes in left ventricle function evaluation by echocardiogram (ECHO) or cardiac MRI
Time frame: from baseline to 12 months at 3, 6, and 12 months post CABG surgery
Changes in 6-minute walk test (6MWT)
Time frame: from baseline to 12 months at 1, 3, 6, and 12 months post CABG surgery
Changes in NYHA functional classification
Time frame: from baseline to 12 months at 1, 3, 6, and 12 months post CABG surgery
Changes in quality of life (QoL)
Time frame: from baseline to 12 months at 1, 3, 6, and 12 months post CABG surgery
Incidence of hospitalization for worsening heart failure
Time frame: 1~12 months post CABG surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
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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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Human (allogeneic) iPS-cell-derived cardiomyocyte in people with Ischemic Heart Failure and Chronic Heart Failure, run by HELP Therapeutics Co., Ltd. at 2 sites 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 7 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiaxian Wang (+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?
Safety in terms of the incidence and severity of adverse events (time frame: within 1 month post CABG 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 22 Nov 2023.