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New treatment option for Coronary Artery Bypass Grafting (CABG)
Official title A Phase I/II Clinical Trial of Intramyocardial Injection of HucMSCs for the Treatment of Chronic Heart Failure
ClinicalTrials.gov ID: NCT07265349
What this study is testing
What is Mesenchymal stem cells(HucMSCs)?
Mesenchymal stem cells(HucMSCs) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for coronary artery bypass grafting (cabg).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- B2278 is a human umbilical cord mesenchymal stem cell (HucMSCs) injection derived from the umbilical cord. It has the advantages of stronger immune regulation, stronger expansion capacity, lower immunogenicity, and greater accessibility.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 1) Age from 18 to 80 years, both genders are eligible ;
- 2) Clinically judged to be suitable for CABG treatment due to chronic ischemic cardiomyopathy;
- 3) LVEF (left ventricular ejection fraction) is ≤ 40% as indicated by echocardiography (modified Simpson method) or cardiac magnetic resonance (CMR);
- 4) NYHA (New York Heart Association) cardiac function classification of grade II-IV;
- 5) Patients or their legal guardians agreed to participate in this trial and signed the informed consent form. Major
You likely can't join if
- 1) Severe left ventricular dysfunction, with LVEF ≤ 20% (based on the UCG or CMR examination results during the screening period);
- 2) Non-ischemic chronic left heart dysfunction, including but not limited to acute left heart dysfunction, dilated cardiomyopathy, severe right heart...
- 3) Clinically determined that other surgical procedures need to be performed simultaneously during CABG surgery, including but not limited to...
- 4) Acute ST-segment elevation myocardial infarction or stroke event within 1 month before enrollment；
- 5) Uncontrolled malignant arrhythmia;
- 6)have undergone or are awaiting heart transplantation or implantation of a left ventricular assist device (LVAD).
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.