Patients with heart failure may benefit of the emerging stem cell therapy according to the recently published results of the RIMECARD Trial.
Improvements in the heart's pumping ability of the patients, in their capacity to perform the normal daily activities and in general, in the quality of their life.
These were the main outcomes observed in the treated patients.
But, let’s see what RIMECARD trial is?
The name RIMECARD comes from the official title of the clinical trial addressed to patient with heart failure: “Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymalon Cardiopathy”
Interest of researcher on using stem cell as treatment for patients with heart failure is not new.
By previous studies conducted in the last decade it was shown the safety and the potential effectiveness of the stem cell infusion in the heart’s blood vessels (coronary arteries) or directly in the heart’s muscle (intramyocardial cell therapy).
For patients with cardiovascular diseases, including heart failure treated in these clinical trials the main source of stem cells used for therapy was bone marrow.
In most of the cases, patients were infused with mesenchymal stem cells derived from bone marrow collected from healthy voluntary donors.
Unlike these previous studies for heart failure patients, in RIMECARD trial were used mesenchymal stem cells derived from umbilical cord tissue voluntary donated by mothers, at birth of their infants.
The study was conducted at Clínica Santa Maria and Clínica Dávila, Chile, between December 2012 and June 2014.
30 patients fulfilled the eligible criteria of this study:
- 18 to 75 years of age
- documented heart failure by sonogram of the heart (echocardiographic assessment)
- under optimal medical treatment for at least 3 months before randomization
These patients with ischemic or nonischemic heart failure were allocated to 2 similar groups:
- first group of patients received intravenously infusion of donated mesenchymal stem cells derived from umbilical cord tissue
- second group of patients received intravenously infusion of placebo (similar solution but without biological effect)
Why mesenchymal stem cells derived from umbilical cord were chosen in this clinical trial addressed to patients with heart failure?
Mesenchymal stem cells are able to form a wide variety of adult cells (multipotency) with low risk of triggering an immune reaction, in case that is infused in a different body (low immunogenicity).
It was proven that the source of mesenchymal stem cells represents an essential factor which conditions the biological properties of these cells.
Thus, umbilical cord derived MSCs are:
- easy and safe to be collected after birth, without any risks for mother or newborn
- can be easy multiplied in vitro
- have less cellular aging
- are devoid of ethical concerns
Besides these advantages, in comparison with stem cells derived from bone marrow, they also exhibited superior:
- ability to form cell clones (clonogenicity)
- to migrate towards damaged tissue
- capacity to secrete active biological molecules (for instance, in vitro they are able to display a 55-fold increase in the expression of a growth factor, known to be involved in genesis of muscle cells, in cell migration and regulation of immune system)
What are the results of RIMECARD trial assessing patients with chronic heart failure?
There were no acute adverse events associated with the infusion of donated UC-MSCs or placebo, confirming the safety of treatment.
Patients from both groups were assessed at 3, 6 and 12 month after infusion of mesenchymal stem cells or placebo.
Only the group of patients infused with umbilical cord derived mesenchymal stem exhibited significant improvements in heart’s pumping function at 3, 6, and 12 months of follow-up.
Heart’s pumping function was assessed by:
- cardiac magnetic resonance imaging (MRI)
- heart functional assessment scale (NYHA)
The conclusion of this clinical study was:
“These findings suggest that umbilical cord derived mesenchymal stem cells could have an impact on clinical outcomes, supporting further testing through large clinical trials.”
Jorge Bartolucci & al. “Safety and Efficacy of the Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in Patients With Heart Failure” Circulation Research. 2017;121:1192-1204