Nanjing Drum Tower Hospital 2026: Heart Failure Trial
Chinese researchers publish HEAL-CHF trial results using 200 million iPSC-derived cardiomyocytes, showing 9 of 10 patients improved with near-doubled walking distance.
Stock photo for illustration only, not from the actual event
- World's first clinical trial injecting iPSC-derived cardiomyocytes for heart failure
- 12-month follow-up shows 9 of 10 trial patients improved daily activity levels
- Used off-the-shelf HiCM-188 cells from HELP Therapeutics with 28-day immunosuppression
- Primary safety endpoints met with no tumors or sustained ventricular tachycardia
Human heart tissue rarely regenerates new muscle cells after birth, leaving heart failure—which affects over 56 million people globally according to Nature Reviews Cardiology—reliant on treatments that only slow degeneration. On August 19, 2026, medical researchers from Nanjing Drum Tower Hospital, affiliated with Nanjing University in China, published the HEAL-CHF clinical trial in Nature Medicine, marking the world's first randomized controlled trial injecting iPSC-derived cardiomyocytes directly into severe heart failure patients.
The study screened 625 patients, enrolled 55, and randomized 20 participants with an average age of 54, comprising 18 men and 2 women. All participants had NYHA class III or IV symptoms and an LVEF of 45% or lower. Recruitment ran from October 2021 to May 2023. All 20 patients underwent Coronary Artery Bypass Grafting (CABG), while the 10 patients in the treatment group received an additional injection of 200 million heart muscle cells across 10 sites around the infarct area.
Stock photo for illustration only, not from the actual event
The injected cells were allogeneic from a donor, produced from mononuclear white blood cells using four transcription factors to reprogram them into pluripotent stem cells before differentiation into cardiomyocytes. Manufacturing took place at HELP Therapeutics' GMP facility in Nanjing under the product name HiCM-188, stored in liquid nitrogen. Treatment group patients received multiple immunosuppressive drugs for 28 days.
At 12 months, primary safety endpoints were successfully met with zero instances of sustained ventricular tachycardia and no new tumor formation detected via PET-CT scans. Secondary efficacy endpoints showed the 6-Minute Walk Distance (6MWD) in the cell-treated group increased by an average of 168.8 meters from baseline compared to 97.25 meters in the control group—nearly double the improvement. Myocardial perfusion and localized wall thickening also showed significant enhancements.
"There were no significant differences between the two groups in left ventricular ejection fraction, left ventricular volumes, scar size, NYHA functional class, and Minnesota Living with Heart Failure Questionnaire scores at 12 months."
Nature Medicine
The HEAL-CHF trial represents a milestone in cardiac regenerative medicine by proving the viability of an off-the-shelf cell therapy model, eliminating the high costs and lengthy wait times of personalized cell manufacturing. Continued long-term monitoring will be essential to confirm the sustained efficacy and safety of these transplanted cellular grafts.
Stock photo for illustration only, not from the actual event
Source: Techsauce
Found something wrong in this article? Report an issue with this article
Comments
Leave a Comment