Heart attack survivors are again being enrolled in a controversial federal study of an alternative treatment while the government investigates whether they were told enough about possible health risks.

The $30 million study, with 1,500 participants so far, is one of the largest alternative medicine experiments ever launched. It tests high doses of vitamin and mineral supplements and chelation, a treatment used for lead poisoning that has not been proved safe or effective for heart disease.

Researchers suspended enrollment last August, when the federal Office of Human Research Protections began a probe into whether the people in the study were being fully informed of risks and adequately protected.

Chelation (pronounced kee-LAY-shun) involves intravenous doses of a drug, in this case disodium EDTA. Proponents claim it can flush out calcium that has built up in artery walls. Stiff or clogged arteries can lead to heart problems. There already are several conventional treatments for heart disease, including medicines, surgery and artery-clearing angioplasty.

When the study began in 2002, it aimed to enroll 2,400 people at more than 100 sites in the United States and Canada. But recruitment has lagged, and study leaders now hope to enroll at least 1,700.

Around a long time, IV Chelation therapy has is detractors and proponents. My wife works for an eye doctor whose father and grandfather had major blockages in their corotid arteries. After undergoing this therapy, both blockages were substantially reduced. It is also practiced in some countries in Europe. The time for a study of this technique is long overdue in the United States. Should chelation therapy prove effective, there won’t be too many patients walking around with 25 stents or bypass surgery scars. Of course, there will also be a great loss of cash flow for both surgeons and interventionalists.

Hmmm.

For the sake of heart disease research, 809 members of the Old Order Amish community agreed to go to a clinic in Lancaster, Pa., near their homes, and drink a rich milkshake that was made mostly of heavy cream. Over the next six hours, a group of investigators took samples of their blood, determining how much fat was churning through their bloodstreams.

Most of the study participants responded as expected — their levels of triglycerides, a common form of fat in the blood, rose steadily for three to four hours and then declined. But about 5 percent had an extraordinary reaction: their triglyceride levels started out low and hardly budged.

It turns out, the researchers report in the Friday issue of the journal Science, that those individuals who barely responded have a mutation that disables one of their two copies of a gene called apoC-III. The gene codes for a protein, APOC3, that normally slows the breakdown of triglycerides.

With the mutated gene, people break down triglycerides unusually quickly. And, the investigators find, they also have low levels of LDL cholesterol, which at high levels increases heart disease risk. They have high levels of HDL cholesterol, which is associated with a decreased risk of heart disease. And they appear to have arteries relatively clear of plaque.

The article goes on to say that clinical applications are “years away”.

Surgeons at The Methodist Hospital in Houston were the first in the nation Thursday to inject highly-concentrated stem cells directly into a patient’s heart, providing an intense, direct hit on damaged heart tissue.

In an investigational study of new heart failure treatments, this promising new technique may be more effective in regenerating healthy heart tissue than current methods that use a catheter to put standard stem cells through the bloodstream into the heart.

The 58-year-old veteran and businessman is resting comfortably and is expected to be discharged this weekend.

“Some patients have such severe heart failure that their only current option is a heart transplant,” said Dr. Brian Bruckner, cardiac surgeon at the Methodist DeBakey Heart & Vascular Center in Houston. “We hope that stem cells will stimulate angiogenesis, the growth of new blood vessels, restore mechanical function in diseased heart tissue, and return patients to a much better quality of life without a transplant.”

In a novel process, the patient’s strongest and most robust stem and progenitor cells, derived from the patient’s own bone marrow, are amplified up to 1,000 times before they’re injected back into the patient’s heart. In the procedure, Dr. Bruckner made a small incision in the left side of the patient’s chest and administered approximately 25 injections of concentrated stem cells into the patient’s heart. All patients in the trial will be followed for 12 months after the injections.

There are currently 5.5 million people in the U.S. suffering from chronic heart failure. A subset of these patients has dilated cardiomyopathy (DCM), a chronic heart disease in which the patient’s heart can not pump effectively enough to deliver blood and oxygen to the vital organs in the body. Patients with DCM typically experience severe limitations to physical activity and shortness of breath.

“Without a new approach to treatment of these patients, they will continue to decline and less than 40 percent will survive five years,” said Bruckner, principal investigator for the trial. “We hope this trial will provide a completely new and viable treatment for them.”

Dr. Michael Reardon, chief of cardiac surgery at Methodist, and Dr. Matthias Loebe, transplant surgeon at Methodist, are co-investigators on the trial. Dr. Kevin Lisman is the patient’s referring cardiologist.

The IMPACT-DCM trial is in phase-II and is seeking to enroll 20 patients with ischemic dilated cardiomyopathy and 20 patients non-ischemic DCM patients at five clinical sites in the U.S.

For more information about the Methodist DeBakey Heart & Vascular Center, see here.

Patient’s own heart muscle cells will generally not divide in a sufficient number to replace the damaged part of the muscle. And if we took a larger part of the patient’s own heart muscle we would make more damage in another area, and things would only become worse. Therefore, we need an external and abundant source of cells for heart muscle repair, and a lot of research effort is ongoing to identify what that source could be. Ideally, stem cells have the potential to be this cell source for the repair of heart damage as they can be proliferated in a dish to large quantities and then potentially steered towards becoming heart cells.

It looks like a heart.

It beats like a heart.

And it has the capability to keep someone alive like a heart.

But this amazing organ wasn’t part of someone’s original equipment. Instead scientists grew it in a lab. And they believe it might one day lead to new ways of treating everything from cardiac disease to transplants.

If this sounds almost inhuman, it is. The ticker actually started as the heart of a dead rat, and was taken by researchers at the University of Minnesota and “washed” of its original cells. That left a shell of the organ which the scientists then injected with new cells culled from newborn rodents. Their excitement was unbounded when the organ started beating on its own.

Those behind the project admit it has a Frankenstein-like element to it, but it also holds so much promise that’s its more boon than bane. “We really have the audacity to claim to build a functional organ from scratch so to speak,” outlines Dr. Doris Taylor. “We’re willing to admit that it’s a crazy idea.”

But what it portends is anything but crazy. The researchers admit a rat heart will never be compatible with humans – but a pig heart might be. As distasteful as that might sound, the chance that it could save the lives of thousands of patients waiting for transplants that are in too short a supply makes it worth exploring.

“Three thousand people a year don’t have other options,” Taylor explains. “We want to make a difference.”

She envisions a system where a pig heart could be “washed”, injected with stem cells from a potential recipient and literally grown from scratch, before being inserted back into the patient. Rejection would be unlikely, since the body would recognize it as its own.

Check out the video.

NEW ORLEANS, November 9, 2008 – Celladon Corporation announced today results from the first nine patients treated with MYDICAR®, a genetically-targeted enzyme replacement therapy for advanced heart failure, showing the product was safe and demonstrating improvement across a number of key parameters. Phase 1 data from the “Calcium Up-Regulation by Percutaneous Administration of Gene Therapy in Cardiac Disease (CUPID Trial), a First-in-Human Phase 1/2 Clinical Trial” were presented at the American Heart Association Scientific Sessions 2008.

This first phase of the multi-center trial was designed to investigate safety and biological effects of restoring SERCA2a enzyme activity in heart muscle cells. The enzyme levels are decreased in late stages of heart failure, and extensive research shows loss of SERCA2a levels represents a common pathway resulting in a defect in the ability of the heart to contract properly. Replacing the enzyme may restore function and reverse heart failure.

As many of us on Plavix know, any surgery can be risky and many surgeons require Plavix to be discontinued for up to 7 days prior to the scheduled procedure. This can lead to in-stent thrombosis, late stage in-stent thrombosis, and more. For more details visit here.

Many cardiologists are now requiring patients with drug-eluting stents to be on a combination therapy of Plavix and Aspirin for at least a year, and some are advocating lifetime combination therapy. Stopping Plavix too soon can lead to in-stent restenosis and your cardiologist should always be consulted prior to stopping either Plavix or Aspirin. What this means for those suffering from ED is that one approach – the implantation of a prosthetic device, can be risky. So what is a heart patient suffering from ED to do?

Ion channel is working on a solution. From their website:

Ion Channel’s report of the phase I trials results for gene transfer for the indication of erectile dysfunction was print published in Human Gene Therapy.

December 21, 2006
Ion Channel’s report of the phase I trials results for gene transfer for the indication of erectile dysfunction was print published in Human Gene Therapy. The article was accepted in November and rapidly published the next month and is the first paper in the issue (that has figure 7) of the paper on the front cover of the journal. The paper is preceded by two editorials each highly complementary of the paper…

Also, from Science Daily:

ScienceDaily (Dec. 4, 2006) — The first human trial of gene transfer therapy for erectile dysfunction (ED) indicates that gene therapy that lasts for months and eliminates the patient’s need for on-demand drugs (such as Viagra and Cialis), could become the future treatment of choice for this common problem, according to a paper in the most recent issue of Human Gene Therapy.

From Medical News Today

Maxi-K gene therapy may be a safe and effective future option for men whose erectile dysfunction (ED) is not treatable with oral therapy. Two studies presented at the 103rd Annual Scientific Meeting of the American Urological Association (AUA) may give hope to these individuals. Researchers present their findings to reporters in a special press conference on May 20, 2008 at 10 a.m.

Maxi-K therapy is a unique, locally administrated gene-transfer technology to treat erectile dysfunction (ED). The safety and the restorative effects of the treatment have been shown by data from participants in a phase I trial. In some men, the effect lasted up to six months. The gene therapy appears safe as no transfer-related adverse events were reported more than two years after the transfer in some subjects. Unlike conventional oral therapies for men with ED, Maxi-K therapy does not require prior planning, fosters sexual spontaneity and can be used by men taking heart medication.

Researchers not only provided follow-up to previous studies on Maxi-K therapy in men, but also explored whether increased erectile function enhanced other areas of sexual behavior. Male cynomulgus monkeys with ED were observed during their injection period and while in the presence of estrogen-implanted females. Researchers observed and measured the monkeys’ number of ejaculations, time to ejaculation, number of mounts, time to first mount, number of thrusts, number of sexual invitations by the female and number of erections achieved. Researchers observed dramatic changes after gene transfer, including increases in the number of partial and full erections and a two-fold increase in erection duration. An increase in intimacy was also seen. The data imply that increased erectile function per se may lead to increased sexual function.

Also, recent studies indicate that Erectile Dysfunction is often a precursor of heart trouble to come or an indicator of existing heart trouble. If you are experiencing ED, I would recommend a thourough checkup by your cardiologist to rule out any heart related issues.