The 12-month period study had 109 participants who were to receive a randomized cell therapy or a placebo. The study required extracting stem cells from a patient's own bone marrow has recorded a 37 percent lower rate of the trial's primary endpoint, a composite of deaths, cardiovascular hospitalizations and clinic visits for unforeseen worsening of heart failure symptoms.
The stem cell human clinical trials research was a phase 2 clinical experiment for a brand-new stem cell therapy referred as ixmyelocel-T. Applying this method, an expert physician gets a sample of bone marrow from a patient taking approximately two weeks to "enhance" it by growing many beneficial stem cells for the same subject's heart muscle to inject with the bone marrow product. The purpose of this procedure is to strengthen the heart by increasing the number of functioning heart muscle cells, which is also known as regenerative therapy.
An estimated 5.1 million people have been affected by heart failure in the United States. This condition weakens the heart which makes it difficult to pump enough blood to meet the body's needs. Patients with severe and end-stage heart failure often have few or no alternative option apart from a heart transplant or a left ventricular assist device.
The stem cell human clinical trials research was a phase 2 clinical experiment for a brand new stem cell therapy referred as ixmyelocel-T. Applying this method, an expert physician gets a sample of bone marrow from a patient which the process approximately takes for two weeks to "enhance" it by growing a number of beneficial stem cells, and then the same subject's heart muscle is injected with the bone marrow product. The purpose of this procedure is to strengthen the heart by increasing the number of functioning heart muscle cells, which is also known as regenerative therapy.
As there is a significant unmet need for treating both class III and IV heart failure, Mr. Henry has said that the stem cell human clinical trials present a strong support that regenerative therapies are giving heart disease patients some other hopeful alternatives.
A total of 109 patients (both class III and IV - ischemic cardiomyopathy) participated in the stem cell clinical trial. Half of the participants (58 patients) were randomly given intramyocardialixmyelocel-T treatment and the other half (51 patients) were selected to get a placebo. Those in the control group had to get a bone marrow extraction and two weeks later will get injected with the placebo. The follow-up was after a 12 month period, the stem cell clinical trial composite primary endpoint was seen in 38 percent of patients given the stem cell therapy which is notably lower than 49 percent of participants that experienced primary endpoint in the control group. The final outcome was that compared to the placebo, the creation of percutaneous intramyocardial delivery of this enhanced bone marrow resulted in a significant reduction in cardiovascular clinical events. The findings are very exciting which pushes the study to conduct a larger one just to confirm the results of reduction in events.
Some of the results of the stem cell human clinical trials for heart disease:
The small-scale stem cell studies have shown some decent amount of improvements for heart failure outcomes. Ixmyelocel therapy shows better results for patients with ischemic cardiomyopathy compared with nonischemic cardiomyopathy. Previous findings show stem cells that are injected via the groin have shown greater success than open heart surgery, so they used the percutaneous approach for the new trials. One of the obstacles of the research is its small size. The trial needs a larger sample of patients who are suffering from heart failures to expand the study of percutaneous, intramyocardialixmyelocel-T treatment.
Patients suffering from heart failure in the end-stage were treated with stem cells harvested from their own individual bone marrow. The result? They experienced a 37 percent decrease in cardiac events compared to a placebo-controlled group. These events included deaths and hospital admissions in correlation with heart failure; proving stem cell clinical trials for heart failure a success.
This is by far the largest stem cell clinical trial for heart failure conducted by ixCELL-DCM which was presented at the 2016 American College of Cardiology annual meeting.
These findings were a significant positive step in proving that stem cell therapy actually works. In the words of cardiac surgeon Amit N. Patel, M.D., MS., Director of Cardiovascular Regenerative Medicine at the University of Utah School of Medicine: "For the last 15 years everyone has been talking about cell therapy and what it can do. These results suggest that it really works." The success of this stem cell clinical trial for heart failure provides cardiac surgeons the ability to continue with even larger trials.
So what were the terms of the study conducted by ixCELL-DCM? It began with a total of 126 patients with end-stage ischemic heart failure. Each patient had bone marrow drawn and mesenchymal stem cells and M2 macrophages were chosen and expanded in the laboratory. Patients were chosen on a random basis for stem cell therapy versus the placebo group. The specific reason for selecting these two types of stem cells were due to the results of previous preclinical studies showing the ability to remodel the heart, develop heart tissue and have an impact on inflammation. This multicellular therapy is also known as ixmyelocel-T. Once injected by a minimally invasive procedure, a 3-dimensional electrochemical system identified areas that needed healing and the stem cells were injected via a catheter. This was not a complicated procedure as it lasted under two hours and patients were generally able to go home the very next day.
Patients were thoroughly monitored and examined at the 1, 3, 6 and 12-month mark. The findings of the stem cell clinical trial for heart failure showed a positive effect. Stem cell therapy patients had fewer side effects and complications than the procedure group. After one year had passed, a full categorization of all events were analyzed for all patients.
The double-blind, stem cell clinical trial for heart failure concluded that a ratio of 8 people versus 4 had fewer deaths for those treated with stem cells than those within the placebo group. The treated group also had less heart failure hospitalizations which contributed to a total of 37 percent decrease in overall cardiac events. Monitoring was completed at the one-year mark.
So while a phase 3 clinical trial is required in order to fully determine if ixmyelocel-T can be given to patients with end-stage heart failure as another alternative to treatments offered today, it has proven a meaningful impact.
A second study for patients suffering from severe ischemic heart disease and heart failure was presented at the American College of Cardiology’s 63rd Annual Scientific Session by lead investigator Anders BruunMathiasen, M.D., research fellow in the Cardiac Catheterization Lab at Rigshospitalet University Hospital Copenhagen. Dr. Mathiasen stated, "our results show that this stem cell treatment is safe and it improves heart function when compared to placebo." Stem cell clinical trials for heart disease have continued to show positive results.
Coronary artery disease (ischemic heart disease) is the leading cause of death for both men and women in the United States. When plaque begins to build up in the heart’s coronary arteries, individuals begin to experience chest pain, heart attacks and heart failure.
This random, 59 patient, double-blinded stem cell clinical trial for heart disease contained the largest placebo-controlled group. Each patient was directly injected by mesenchymal stromal cells into the heart. The stem cells were extracted from the bone marrow through a minimally invasive procedure. Researchers then induced the cells so they would self-replicate.
The results? After six months of observation, patients that were treated with stem cell injections improved their heart pump functions as opposed to the placebo group. The systolic volume indicates the lowest volume of blood in the heart when pumping. Patients that were treated decreased by 8.3 mm which improved their heart’s ability to pump effectively. In comparison, the placebo group actually increased by 6mm.
In addition, the stem cell clinical trial for heart disease proved to offer reduced scar tissue in the heart supporting the theory that stem cell treatment stimulates growth of heart muscle cells. A phase 3 stem cell clinical trial for heart disease will be required prior for approval of this treatment for heart disease.