Intramyocardial umbilical‑cord mesenchymal stem cell injection with CABG for chronic ischemic heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting
• Shanghai General Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• Changhai Hospital
  Shanghai, Shanghai Municipality, China Not yet recruiting
• Shanghai Chest Hospital
  Shanghai, Shanghai Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Qiang Zhao
• Email: Zq11607@rjb.com.cn
• Phone: 86+13701695256

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.