Intramyocardial umbilical‑cord mesenchymal stem cell injection with CABG for chronic ischemic heart failure
A Phase I/II Clinical Trial to Evaluate the Safety and Efficacy of Intramyocardial Injection of Human Umbilical Cord Mesenchymal Stem Cells (HucMSCs) Combined With Coronary Artery Bypass Grafting in the Treatment of Chronic Heart Failure Caused by Chronic Ischemic Cardiomyopathy
This trial will test whether injecting umbilical‑cord derived mesenchymal stem cells into the heart at the time of bypass surgery helps people with chronic ischemic heart failure and reduced ejection fraction.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 51 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Tasly Pharmaceutical Group Co., Ltd Industry-sponsored |
| Locations | 4 sites (Shanghai, Shanghai Municipality and 3 other locations) |
| Trial ID | NCT07265349 on ClinicalTrials.gov |
What this trial studies
This is a multicenter Phase I/II trial of B2278, a human umbilical cord mesenchymal stem cell (HucMSC) injection, given by intramyocardial injection in combination with coronary artery bypass grafting to patients with chronic ischemic cardiomyopathy and LVEF ≤ 40%. The Phase I portion explores doses and regimen while Phase II expands to assess safety, tolerability and preliminary efficacy signals after surgery. The product is proposed to promote reparative macrophage polarization, angiogenesis and reduced inflammation based on preliminary data. The trial is being conducted at major cardiac centers in Shanghai and includes clinical and imaging follow‑up to monitor cardiac function and adverse events.
Who should consider this trial
Good fit: Adults aged 18–80 with chronic ischemic cardiomyopathy scheduled for CABG who have LVEF ≤ 40% and NYHA class II–IV are the intended participants.
Not a fit: Patients with non‑ischemic cardiomyopathy, very severe left ventricular dysfunction (LVEF ≤ 20%), severe right heart failure, or those not undergoing CABG are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the treatment could improve heart muscle repair, increase blood vessel growth, and improve heart function and symptoms after bypass surgery.
How similar studies have performed: Early-phase trials of mesenchymal stem cell therapies for ischemic heart disease have generally shown acceptable safety and occasional modest functional benefits, but larger trials have had mixed results and umbilical‑cord derived products remain relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 exclusion Criteria: * 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 dysfunction (such as bilateral lower extremity edema accompanied by jugular vein distension, liver enlargement, etc.) or severe pulmonary hypertension (PASP \> 70 mmHg); * 3\) Clinically determined that other surgical procedures need to be performed simultaneously during CABG surgery, including but not limited to congenital heart disease requiring concurrent surgical intervention, heart valve disease, ventricular aneurysm, ventricular septal perforation, papillary muscle dysfunction, aortic dissection, intracardiac mass, thrombus or neoplasm； * 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).
Where this trial is running
Shanghai, Shanghai Municipality and 3 other locations
- Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
- Changhai Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
- Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
- Shanghai General Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Qiang Zhao
- Email: Zq11607@rjb.com.cn
- Phone: 86+13701695256
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.