HiCM-188 Cell Therapy in Adults With Advanced Heart Failure Undergoing Heart Bypass Surgery
A Phase I/IIa, Open-Label, Dose Escalation Study to Evaluate the Safety and Tolerability of HiCM-188, an Allogeneic iPSC-derived Cardiomyocyte Therapy, in Adult Patients With Advanced Heart Failure
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 75 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 12 months
- Procedures mentioned: Injections
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants who meet the study eligibility criteria will receive a single dose intramyocardial injection of HiCM-188 during CABG surgery."
- "Participants will be followed for up to 12 months after treatment to monitor safety and preliminary signs of clinical effect."
- "The primary objective is to evaluate the safety and tolerability of intramyocardial injection of HiCM-188."
- "Participants will be monitored during the in-hospital period after CABG surgery and HiCM-188 administration, and then followed for up to 12 months after treatment."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety of HiCM-188, an experimental heart muscle cell treatment made from donor stem cells. It is for adults with advanced heart failure who are having heart bypass surgery. Patients will get one dose injected into the heart muscle during surgery and have follow-up checks for up to 12 months.
This clinical study will evaluate the safety and tolerability of HiCM-188, an investigational allogeneic induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy, in adults with advanced heart failure who are undergoing coronary artery bypass grafting (CABG) surgery. Participants who meet the study eligibility criteria will receive a single dose intramyocardial injection of HiCM-188 during CABG surgery. The study will evaluate two dose levels of HiCM-188 using an open-label dose-escalation design. Participants will be followed for up to 12 months after treatment to monitor safety and preliminary signs of clinical effect.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be able to sign a consent form and follow study rules.
- Be 18 to 75 years old when signing the consent form.
- Have advanced heart failure, rated NYHA class III to IVa, even with recommended medicines.
- Need heart bypass surgery under the guideline rules used by the study.
- Have heart muscle at least 8 mm thick where the cells will be injected, as shown on a heart scan.
- Have a left ventricle pumping rate of 20% to 45% on a heart scan. This is how much blood the heart’s main pumping chamber pushes out with each beat.
- Other rules apply. Ask the study doctor for details.
Who can't join
- Heart muscle swelling caused by a virus, or amyloidosis, a disease that causes abnormal protein buildup.
- Disease or swelling of the sac around the heart.
- A bulge or blood clot in the heart’s main pumping chamber. A small, flat clot at an old heart attack site in a different area may be allowed.
- Major heart valve disease that meets the study’s rules for type and size.
- An untreated heart problem present since birth.
- Complete heart block, meaning electrical signals cannot pass from the upper to the lower heart chambers.
- Past surgery to place a left ventricular assist device, a pump that helps the heart move blood.
- Other rules apply. Ask the study doctor for details.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Able to sign informed consent and comply with the study protocol * 18 to 75 years old at the time of signing informed consent * Advanced heart failure patients with New York Heart Association (NYHA) class III to IVa despite receiving guideline-directed medical therapy (GDMT) * Patients with an indication for coronary artery bypass grafting (CABG) per 2011 ACCF/AHA Guideline meeting a Class of Recommendation (COR) of Class I or Class IIa * Minimum left ventricular wall thickness of ≥ 8 mm in the areas of injection, as confirmed on the screening echocardiogram (ECHO) or cardiac MRI * Left ventricular ejection fraction (LVEF) of 20% to 45%, as confirmed on the screening echocardiogram (ECHO) or cardiac MRI * Other criteria apply. Please contact the investigator for more information. Exclusion Criteria: * Viral myocarditis * Amyloidosis * Pericardial disorders or pericarditis * Left ventricular aneurysm or thrombus, except a small laminar thrombus at the site of previous myocardial infarction (MI) in a different area * Primary significant organic valvular heart disease, with specified dimensions * Untreated congenital heart disease * Complete atrioventricular (AV) conduction block * History of left ventricular assist device surgery * Other criteria apply. Please contact the investigator for more information.
Study sites (1)
TX
- The Texas Heart Institute at Baylor College of Medicine · Houston, TX 77030Emerson Perin · Principal investigatorMore trials in Houston