Newly published research (April 2017) using Autologous Stem Cells is showing promising results for treating Cardiomyopathy. Continue reading to learn more about these advancements.

Even with early detection and the excellent range of treatment options available, heart failure is a life-threatening condition with high mortality. When caused by ischemic cardiomyopathy, a side effect of Coronary Artery Disease (CAD), a patient’s heart is no longer strong enough to pump blood to the tissues of their bodies according to need.  The heart is weakened by a steady narrowing of the blood vessels tasked with delivering blood and life-giving oxygen to the heart muscle.  In the case of dilated cardiomyopathy, the left ventricle (the heart’s primary pumping chamber) is weakened and enlarged by dilatation.  Patients with this condition find that their hearts cannot sufficiently pump the blood to keep up with the needs of the heart muscle itself and the rest of the body, which leads to further weakening and further heart failure- a vicious circle.

Although innovative drug therapies and surgical interventions have long been used to combat these serious and life-threatening effects, these therapies have limited longevity and do not always lead to longer life or a return to an active lifestyle.  Heart transplantation, which has been an accepted last option for heart disease sufferers, is plagued by a shortage of suitable donors and long waiting lists for treatment.  With this in mind, researchers and clinicians have been exploring other alternative methods for treating heart failure.  In a recent study by the Osaka University Graduate School of Medicine in Osaka, Japan, and published in the Journal of the American Heart Association, researchers developed an implantation method using autologous cell-sheets to heal severely damaged myocardium (the muscle tissue of the heart itself). The results were very promising, which points toward further research into cell-sheet implantation with or without existing treatment options to maximize efficacy.

Using Autologous Cell-Sheets

Between January 2010 and February 2015, twenty-seven patients with both ischemic (related to reduced blood flow in the coronary arteries) and non-ischemic heart failure were enrolled in the study.  Each of these patients had exhausted the maximum medical treatment; seven had previously been fitted with a cardiac defibrillator, and another eight had undergone cardiac resynchronization.  No medication changes or resetting of the resynchronization device was undertaken prior to or following the implantation procedure. Since this procedure utilized autologous (derived from the patient’s own native cells) tissues, each of the patients had muscle specimens collected from the quadriceps muscles of the each patient’s thighs.  These muscle fibers were then cultured in a lab to configure the cells into sheets that could be layer-implanted within the patient’s own heart muscle.  Each sheet was 3-4 muscle-fiber layers thick and spiraled round to a diameter of approximately 4 cm. This was transplanted under general anesthesia. Safety and feasibility results for the study were collected and based upon the occurrence of a “major cardiac event,” defined as either infection, cardiac arrest, worsening congestive heart failure, hospitalization, or death within the six months following the procedure.

Using the Six-Minute Walk Test, a baseline for exercise capacity was recorded before treatment as well as six months following the implantation.  Patients’ reported symptoms were also evaluated before treatment, and again at both the 6-month and 12-month marks. None of the patients showed any procedure-related complications. Neither the defibrillator patients nor the cardiac re-synchronization patients reported the need for their prior implants to be reset or realign cardiac rhythms mechanically following the cell-sheet implantation. No lethal dysrhythmias or ventricular fibrillation were observed in any patients following the procedure, and only two of the patients developed any worsening congestive heart failure within the 6-month observation period.  Thirteen of the fifteen patients, therefore, showed significant improvement in cardiac function and activity capability.  Conducting the Six-Minute Walking Test at the 6-month and 12-month marks following treatment showed marked improvements in both distance and energy levels reported by the patients with ischemic etiology, and these improvements continued for a long period following the procedure.  The overall survival rate for this procedure was 96% at one year and 75% at the three-year mark, although within the ischemic population of the patients the survival rate was 100% at 12-months.

Showing Great Promise

This shows great promise for the treatment of ischemic cardiomyopathy by using autologous cell-sheet implantation, although further research into how to properly utilize this innovative method to treat dilated cardiomyopathy is needed.  It is important to note that the pre-treatment incident of heart failure, adverse events across the sample population was around 0.91 events/patient-years. With cell-sheet implantation, even in an experimental trial setting (this trial constituted the “first-man” phase of human trials following extensive research on small and large animal subjects) reduced the incidence of heart failure adverse events to 0.38 events/patient-years in the postoperative period.

This study shows the potential for autologous skeletal muscle sheet, rich in stem cells (derived from a patient’s own skeletal muscle fibers) to serve as a therapy for individuals with severe heart failure who have already exhausted their options medically for treatment.  This trial illustrates that implanting muscle tissue, as cultured sheets, is feasible for heart failure patients, especially those with CAD and ischemia.  The cell-sheets provide increased muscle tone and strength to the weakened cardiac muscles, improving the patients’ quality of life, extending their lives and decreasing their reliance on mechanical implants and costly medicines.  Almost all patients reported an improvement in exercise capacity, which is necessary to maintain a healthy lifestyle at any age.  Even where systolic function was not noticeably affected, symptom recognition and exercise capacity showed a marked improvement.  Pulmonary hypertension was decreased across the board with reported reductions in pulmonary arterial pressure (PAP) and the other parameters used to measure blood flow and resistance in arteries, which led to less day-to-day damage on the heart muscle and related structures.  Also, with the reduction of postoperative heart failure events requiring inpatient hospitalization and treatment, the use of cell-sheet implantation can reduce inherent medical costs related to heart failure.

Although further studies are needed to test this hypothesis, researchers believe the stem cells among the sheets of muscle fibers secrete cytokines and growth factors that are complex molecules normally secreted by the immune system and other cells that positively affect the surrounding cells and tissues.  Two of these factors are believed to help repair structures of the vascular system and reduces symptoms of hypertension. Even with this additional research, the primary study has highlighted the improved quality of life, increased survival rates, and lower medical costs associated with the cell-sheet procedure. The promising results related to safety, patient reported symptom recovery, as well as medically-reported functional recovery seen in this pilot study point to a need for further clinical follow up as well as larger-scale studies to confirm these results in the treatment of severe heart failure.

Promoting Healing and Tissue Regeneration

At Gulf Coast Stem Cell Regenerative Center (GCSC), which is an affiliate partner of the Cell Surgical Network, we conduct patient-funded research with the intention of promoting healing and tissue regeneration in patients with their own autologous stem cells. More specifically, we use Stromal Vascular Fraction (SVF), which is rich in stem cells and growth factors for general as well as specific goals of therapy and repair. The SVF is collected from a patient’s fatty tissue with a small liposuction procedure. The tissue is minimally processed to concentrate the SVF and growth factors before being injected back into the patient at the required treatment site(s).

Gulf Coast Stem Cell and Regenerative Medicine Center - Ocean Springs, MS.Part of our mission is exploring the regenerative potential of stem cells and delivering “Excellence with a human touch.” We aid in the management of autoimmune, degenerative, inflammatory, and ischemic conditions. Our highly-skilled team of providers is committed to the goal of alleviating symptoms, enhancing functionality, and improving overall quality-of-life for our patients.

While much of this research is still in the early stages, The Gulf Coast Stem Cell and Regenerative Medicine Center is excited to be at the forefront of medicine’s future. Utilizing state-of-the-art research methods and some of the finest analytical minds on the Gulf Coast, we endeavor to push forward the progress of regenerative medicine while bringing the exciting results and new procedures home to help our local community. Gulf Coast Stem Cell uses a safe and minimally invasive procedure to collect and utilize patients’ adipose-derived stem cells for use in the management of various health conditions. 

Interested patients can fill out a confidential candidate application or call (866) 885-4823. A dedicated member of the Gulf Coast Stem Cell and Regenerative Medicine Center team will happily discuss any questions or concerns you may have.  

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