Study: Stem Cell Therapy Shows Improvement in QoL for Those With Heart Failure

Stem cell-based therapy has been shown to improve the quality of life for those with advanced heart failure (HF), according to investigators at Mayo Clinic. In the late-stage, multinational clinical trial, patients reported their daily hardships lessened with stem cell therapy for heart repair compared to the standard of care.¹

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"In this era of global aging, [individuals] live longer, yet are at risk of chronic disease imposing a poor quality of life. [HF] is an emerging epidemic in need of new healing options," Andre Terzic, MD, PhD, a cardiovascular investigator at Mayo Clinic, said in a press release. "The stem cell-based approach in the present study demonstrates sustained benefit on physical and emotional health in response to biotherapy."¹

In a report by the American Heart Association, from 2017 to 2020, approximately 6.7 Americans aged 20 and older had HF, increasing from approximately 6 million from 2015 to 2018. However, from 1979 to 2000, the survival rate for HF diagnosis improved.²

Additionally, investigators found that the results demonstrated lower death and hospitalization rates for those treated with cell therapy. The clinical trial was double blinded for both patients and health care providers.¹

The investigators included 315 individuals from 39 hospitals in 10 countries who had advanced HF, despite receiving the standard of care. They randomized treatment for the individuals creating 2 groups: a group receiving stem cell therapy and one that would not receive this therapy. Further, for those who received the stem cell therapy, they also underwent cardiac catheterization. The stem cells were taken from the patients’ bone marrow and programmed to heal damaged heart tissue, according to the press release. Those who did not received stem cells had cardiac catheterization without the cell delivery.¹

"Data from one of the largest cardiovascular cell therapy trials, testing a regenerative technology discovered at Mayo Clinic, indicate benefit in both quantity and quality of life in advanced heart disease," Satsuki Yamada, MD, PhD, a cardiovascular researcher at Mayo Clinic, said in the press release. "The benefit of regenerative care has been typically evaluated on the basis of clinician-reported outcomes. What's unique in this study is that it was designed to listen to the patient's experience."¹

The individuals completed a self-assessment made of 21 questions at the beginning of the study, then again at 26, 39, and 52 weeks following treatment. In the follow up, investigators reported that the quality of life for those with pre-existing left cardiac chamber enlargement improved for those who were treated with cell therapy compared to those who received the standard-of-care. For death and hospitalizations, there were lower rated for those who received stem cell treatment.¹

The press release stated that further clinical studies are needed to validate the findings found in this study.¹ The results were published in Stem Cells Translational Medicine.^1,3

References

1. Clinical trial finds cell therapy improves quality of life in advanced heart failure. News release. Mayo Clinic. December 12, 2023. Accessed December 13, 2023. https://newsnetwork.mayoclinic.org/discussion/clinical-trial-finds-cell-therapy-improves-quality-of-life-in-advanced-heart-failure/
2. Tsao CW, Aday AW, Almarzooq ZI Anderson CAM, et al. Heart Disease and Stroke Statistics-2023 Update: A Report From the American Heart Association. Circulation. 2023;147(8):e93-e621. doi:10.1161/CIR.0000000000001123
3. Yamada S, Bartunek J, Povsic TJ, Cotter G, et al. Cell Therapy Improves Quality-of-Life in Heart Failure: Outcomes From a Phase III Clinical Trial. Stem Cells Transl Med. Published online November 24, 2023. doi:10.1093/stcltm/szad078