THE HEART STUDY

Organ Regeneration 

The best evidence to date showing the promise of stem cell therapy is a study that used a laser guided stem cell therapy to rebuild cardiac muscle in chronic heart failure. These results are compared to using stem cells directly injected into the arteries or muscle of the heart through an invasive procedure. In a meta-analysis that compiled the results of multiple published studies, a total of 1494 patients were treated through a cardiac catheterization procedure. With this method there was an approximately 8% increase in heart function 180 days after the cells were administered.

With direct injection into the heart essentially 100% of the cells were delivered to the target location. Based on proportional cell delivery, this approach would be expected to be at least 10 times better than using the cells intravenously. The reason is that only about 10% of cells infused into a vein would circulate through the heart as opposed to going to other tissues.

Laser Guided Stem Cell Study

A laser guided stem cell study was conducted in Eastern Europe, and 10 men with severe end stage heart failure were treated. A normal heart pumps out 50-65% of the blood in the ventricles in the resting state. This percentage is called the cardiac ejection fraction (EF). When this falls below 50%, heart failure is said to be present. When the EF is less than 30%, severe heart failure is defined.

The persons in this study had severe, end stage heart disease with an average ejection fraction of 21%, and were considered candidates for heart transplantation.

This study used cord blood stem cells. The cells were derived from the blood in the umbilical cord of healthy newborn babies. Such cells are heavily tested for safety before they are used clinically.

After informed consent from each patient, the cells were activated with the laser protocol for this purpose and then infused IV. Then a laser guidance process was used directing the beam toward the heart from the anterior chest and left lateral chest to give the strongest signals for localization to the heart muscle.

The first follow up testing was done 3 days after the procedure.

By the third day the average improvement in heart function was 14%. This increased further to about 25% in one month, 37% in 2 months and 50% in 3 months.

Half of the men improved so much that they were taken off the heart transplant list and 20% improved dramatically to nearly normal heart function after a single application.

All the patients had improved function after 3 months. The least improved patient was 15% better. The greatest increase in function was 115% from an ejection fraction of 20% to 43%, or an enhancement of function nearly to a normal level.

A tissue repair index is a measure of the amount of change divided by the number of days since the treatment. The cardiac repair index is the percentage change in heart function ( new EF - original EF/ original EF) x 100%) divided by the number of days since the intervention.

At 3 days post laser guided stem cells the cardiac repair index was 4.8% per day. For cells infused directly into the heart, the measured cardiac repair index at 6 months was .044% per day. The expected result was that intra-cardiac cells would work 10 times better. Instead the laser guided cells given IV achieved a cardiac repair index that was over 100 times greater than direct intra-cardiac delivery. This suggests that both the rate and degree of regeneration can be increased with laser guidance.

Therapeutic Results

The heart failure study illustrates the range of results. After 3 months 100% of the persons treated were improved. The least improvement was a 15% increase in function, whereas the greatest was a more than doubling benefits that have been faster and better than other methods. That said, results are variable from person to person and time to time. There are factors of diet, lifestyle, stress levels, associated conditions and treatments and individual variability that can have an influence.

While results have been generally good it is not possible to guarantee any particular response for a given treatment. It is possible that little or no benefit will occur, and also that an improvement could regress although this has not been clinically observed.