A Phase I/II Clinical Trial of Intramyocardial Injection of HucMSCs for the Treatment of Chronic Heart Failure
Recruiting
Phase 1
Phase 2
Interventional Study
Coronary Artery Bypass Grafting (CABG)
Chronic Heart Failure
Chronic Ischemic Cardiomyopathy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 51 (estimated)
- Sponsor
- Tasly Pharmaceutical Group Co., Ltd · Industry
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About This Trial
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, d…
Trial Locations
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Eligibility 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 car…
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