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Coronary Artery Bypass Grafting (CABG)Phase 1/2NCT07265349

A Phase I/II Clinical Trial of Intramyocardial Injection of HucMSCs for the Treatment of Chronic Heart Failure

A Phase 1/2 study testing Mesenchymal stem cells(HucMSCs) and CABG in people with Coronary Artery Bypass Grafting (CABG) and Chronic Heart Failure, run by Tasly Pharmaceutical Group Co., Ltd at 4 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Mesenchymal stem cells(HucMSCs) and CABG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
4 sitesChina
Study dates
26 Dec 2025to 1 Aug 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 12Show fewer
  • 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).

Who cannot join

None listed.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Qiang Zhao contact

86+13701695256

Zq11607@rjb.com.cn

China4 sites, 4 recruiting

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 20000

    Qiang Zhao, 86+13701695256, Zq11607@rjb.com.cn

    Qiang Zhao

    Recruiting

  • Changhai Hospital

    Shanghai, Shanghai Municipality

    Lin Han, 86+13601914266, sh_hanlin@163.com

    Lin Han

    Not yet recruiting

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality

    Dan Zhu, 86+13671573807, zhudanmd@163.com

    Dan Zhu

    Not yet recruiting

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality

    Fanglin Lu, 86+13901649602, drlufanglin@yeah.net

    Fanglin Lu

    Recruiting

Other trials in China

About this study

Official title: 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

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. The preliminary research results indicated that the B2278 injection promote the polarization of macrophages towards a reparative state through paracrine action, directly promote angiogenesis and inhibited inflammatory responses, thereby exerting effects on myocardial repair and treatment of heart failure, and it is also safe and well-tolerated.

This trial is a multi-center I/II phase clinical trial of the human umbilical cord mesenchymal stem cell injection solution, aiming to explore the dosage and regimen for the intramyocardial injection of B2278 in combination with coronary artery bypass grafting surgery for the treatment of chronic heart failure caused by chronic ischemic cardiomyopathy, and to evaluate the safety, tolerance and efficacy of allogeneic intramyocardial injection of the human umbilical cord mesenchymal stem cell injection solution in patients with chronic ischemic heart failure.

Being tested
Mesenchymal stem cells(HucMSCs), CABG

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mesenchymal stem cells(HucMSCs)Drug

    B2278 is mesenchymal stem cells derived from human umbilical cord.

  • CABGProcedure or surgery

    only CABG

Study groups in NCT07265349
Study groupRoleWhat they receive
CABG combined with low-dose B2278ExperimentalCABG combined with B2278 at a dose of 1.0×10^7 cells per patient, intramyocardial injection into the epicardium
Receives: Drug: Mesenchymal stem cells(HucMSCs)
CABG combined with midium-dose B2278ExperimentalCABG combined with B2278 at a dose of 5.0×10^7 cells per patient, intramyocardial injection into the epicardium
Receives: Drug: Mesenchymal stem cells(HucMSCs)
CABG combined with high-dose B2278ExperimentalCABG combined with B2278 at a dose of 2.0×10^8 cells per patient, intramyocardial injection into the epicardium
Receives: Drug: Mesenchymal stem cells(HucMSCs)
Only CABGExperimentalOnly CABG surgery
Receives: Procedure: CABG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In phase I, primary outcome will be measured with safety events including DLT, AE, SAE, TEAE, and MACE. In phase II, primary outcome will be measured with the change in LVEF based on CMR detection after 6 months of administration.

    Measured: 6 months

Secondary outcomes (9)

  1. The changes in left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume (LVEDV), and left ventricular end-systolic volume (LVESV) on CMR compared to the baseline.

    Measured: 6 months

  2. The changes from baseline of LVEF, left ventricular end-systolic diameter (LVESD), left ventricular end-diastolic diameter (LVEDD), LVEDV, LVESV on UCG

    Measured: 28 days, 3 months and 6 months

  3. The proportion of participants with improved LVEF (the proportion of participants whose LVEF increased by ≥10% compared to the baseline and whose LVEF was >40% based on CMR and/or UCG);

    Measured: 3 months and 6 months

  4. The distribution of the New York Heart Association (NYHA) cardiac function classification

    Measured: 28 days, 3 months and 6 months

  5. The proportion of participants with NYHA classification ≤ II level

    Measured: 28 days, 3months and 6months

  6. The changes in the 6-minute walk test (6MWT) results compared to the baseline

    Measured: 28 days, 3 months and 6months

  7. The changes in the Minnesota Heart Failure Quality of Life Questionnaire (MLHFQ) from the baseline

    Measured: 28 days, 3months and 6months

  8. The change in the result of amino-terminal pro-brain natriuretic peptide (NT-proBNP) compared to the baseline

    Measured: 28 days, 3months and 6months

  9. The proportion of participants whose heart failure worsened (requiring hospitalization or emergency treatment due to the aggravation of heart failure symptoms and signs)

    Measured: 3 months and 6months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2025
  2. Study start26 Dec 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07265349
Sponsor's protocol ID
TASLY-BM-B2278-HF-I/Ⅱ
Status last verified
Jan 2026
First submitted
20 Nov 2025
Last updated
9 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Mesenchymal stem cells(HucMSCs) and CABG in people with Coronary Artery Bypass Grafting (CABG) and Chronic Heart Failure, run by Tasly Pharmaceutical Group Co., Ltd at 4 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 12 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Qiang Zhao (86+13701695256, Zq11607@rjb.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In phase I, primary outcome will be measured with safety events including DLT, AE, SAE, TEAE, and MACE. In phase II, primary outcome will be measured with the change in LVEF based on CMR detection after 6 months of administration. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07265349.

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 9 Jan 2026.

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