Stem cell patch observed to reduce heart failure-related hospitalizations.
Stem cell-based therapies have been explored in various conditions, including multiple sclerosis, atopic dermatitis, and numerous cancers. Thus far, there are no approved stem cell-based products, other than umbilical cord blood-derived hematopoietic progenitor cells, according to the FDA.
A new study published by the Journal of the American Heart Association explored the use of a stem cell patch in patients with heart disease. The authors discovered that the patch, which was made of the patient’s muscle stem cells, improved the symptoms of heart failure caused by ischemic cardiomyopathy or dilated cardiomyopathy.
Current methods for heart failure treatment include prescription drugs, implanted devices, and lifestyle modifications, but these treatments may not be effective for all patients. Other options, such as heart transplant, are limited, which highlights the need for alternative treatments.
The phase 1 clinical trial was designed to evaluate the safety and efficacy of the novel stem cell patch. In the study, the authors developed the patch from stem cells taken from the thigh muscles of patients with heart failure. The novel patch was then surgically “glued” onto the damaged areas of the patients’ hearts.
Included in the study were 27 patients with heart failure who received the therapy. Prior to the treatment, these patients were reported to have limited ability to exercise and were not responding to traditional treatments, according to the study.
The authors discovered that the treatment showed great improvement regarding heart function and exercise ability. Although the patients’ conditions improved, the findings were modest, according to the study.
The authors reported that no patients experienced procedure-related adverse events, and only 2 patients developed congestive heart failure within 6 months of treatment, which suggests that the patch can generally be considered safe, according to the study.
At 1 year, the survival rate was 96%, dropping to 84.3% at 3 years, with only 3 deaths occurring from gastrointestinal bleeding, arrhythmia, and heart failure.
The stem cell patch was also observed to reduce hospitalization related to heart failure events. Prior to the treatment, the authors found that the incidents of heart failure events were 0.91 event/patients-years, while it was substantially reduced to 0.38 event/patients-years after the treatment, according to the study.
“In addition to functional and symptomatic improvements, cardiac survival rate and lower freedom from heart failure events requiring in‐hospital treatment after sheet therapy, which lead to lower medical costs for heart failure, were satisfactory,” the authors wrote.
Overall, the positive findings indicate that the experimental stem cell patch may be safe and efficient for treating patients with cardiomyopathy who have inadequate disease control on current treatments.
“This Phase I study found cell‐sheet transplantation as a sole therapy to be a feasible treatment for cardiomyopathy,” the authors concluded. “The promising results in the safety and functional recovery seen in this study warrant further clinical follow‐up and larger studies to confirm the therapeutic efficacy of autologous skeletal stem‐cell sheets for severe congestive heart failure.”