VesCell™ Treatment for Heart Disease FAQ

The most common form of heart disease is coronary heart disease, which is an ischemia or a reduction of blood flow caused by blockage in the arteries. Over time this reduced flow of blood to the heart muscle causes cardiomyopathy, or actual damage to the heart muscle tissue. If the reduction in blood flow is significant, portions of heart tissue stop functioning altogether. When the damaged area becomes too large, the heart cannot pump blood efficiently and heart failure occurs.

Sudden reductions of blood flow to the heart (heart attacks) or a gradual reduction in flow cause chest pains (angina pectoris) and shortness of breath during physical activity. This makes everyday activities like walking or climbing stairs difficult or impossible. As the condition worsens, the patient loses the ability to perform even the simplest physical task.

While VesCell™ therapy may not cure heart disease, it can substantially improve the flow of blood to the heart in a large majority of patients. The result is fewer chest pains and a dramatic increase in physical capacity. In as little as a month after treatment, patients experience an improvement in quality of life and are again able to enjoy activities once restricted by their illness.

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VesCell™ is a proprietary "autologous" stem cell therapy developed by TheraVitae. Stem cells are taken from the patient, processed, and then given back to the same patient.

Autologous stem cell therapy has numerous advantages.  Unlike embryonic stem cells, there are no ethical considerations to using autologous stem cells because they come from the patient they will treat, there is no chance of the patient rejecting the cells, and there is no risk of contracting infectious blood borne diseases.

VesCell™ therapy uses angiogenic cell precursors, or ACPs, the stem cells whose normal function is to repair damaged blood vessels.  When injected into and around the heart, these cells build new blood vessels and restore function to the damaged heart tissue.

Unlike other autologous adult stem cell therapies, which harvest stem cells from bone marrow, VesCell’s harvesting process is simple and as non-invasive as making a blood donation. From a blood sample, APCs are isolated and then prompted to multiply in vitro before being given back to the patient.

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Cardiologists and heart surgeons worldwide currently use VesCell™ to treat patients suffering from coronary artery disease, cardiomyopathy, and congestive heart failure.

Many candidates for VesCell™ therapy have exhausted their other treatment options.  But VesCell™ can, in most cases, be used in conjunction with coronary artery bypass graft surgery and angioplasty.

VesCell™ stem cell therapy may also be a viable alternative for patients with other medical conditions that make conventional procedures too risky or otherwise not possible.

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VesCell™ therapy is not yet approved by the U.S. Food and Drug Administration, so it is not available in the U.S. Although VesCell™ therapy has undergone clinical trials in Thailand, is currently undergoing trials in Hungary, and is expected to gain European Commission certification early next year, it will be several years before U.S. trials are completed.

The process of gaining FDA approval for a new drug or medical procedure is one of the most expensive and time consuming in the world. We are confident that VesCell™ will eventually gain FDA approval, but believe that this valuable therapy can save lives now.

TheraVitae’s experienced American management-team has designed a program to make VesCell™ stem cell therapy easily accessible to patients.  With U.S. trained and accredited cardiologists and heart surgeons performing VesCell™ treatments in thoroughly modern hospitals, you can be assured that you will receive the best care available anywhere in the world.

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The process begins with a thorough medical screening by world-class cardiologists to decide if the therapy will benefit the patient and if so, which treatment will help the most. Once accepted, the patient travels to a treating hospital where a cardiologist conducts a physical examination to determine the details of the procedure, specifically where to implant the cells. Next, a 250 ml sample of blood (about 1/2 pint) is drawn from the patient and couriered to our laboratory facility in Israel. Although the patient’s blood contains the stem cells, there are far too few to be effective on their own. VesCell™ stem cell treatment uses proprietary processes developed by TheraVitae to isolate and multiply these stem cells. Within five days, their numbers increase from 20,000 to 20 million. These cells are couriered back to the treating hospital where they are either implanted into one or more of the patient's coronary arteries or injected directly into the patient's heart muscle depending upon the pre-arrival diagnosis.  The patient spends a few days under observation and then returns home.

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The first step is to call TheraVitae. You will be assigned a personal consultant who will assist you in gathering everything you need.  A cardiologist will then review your medical records and may consult your regular cardiologist.  Normally, the reviewing physician will ask to see recent diagnostic results. If they are not available, he may request that you provide them. There is no charge or obligation for this medical review process.

About 1/3 of our applicants do not qualify for treatment, either because the doctors don’t think they will benefit from the procedure or because the patient has another serious medical condition.  Disqualifying conditions include recent cancer, HIV, or Hepatitis B and C.

If you qualify, a cardiologist will recommend the appropriate course of treatment.

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The inclusive cost for your treatment is $39,500 for the direct injection procedure or $36,500 for the catheter-based treatment. This includes the following services:

• VesCell™ collection, transportation, and processing of your stem cells by highly trained cell biologists and immunologists at our lab in Israel.
• All hospital charges for the cell harvesting and delivery procedures, including room and board, incidental charges, catherization charges, operating room charges, ICU/CCU charges, and post-therapy testing.
• All physician charges directly related to your VesCell™ adult stem cell therapy including: attending cardiologists, invasive cardiologist for catheter cell implants or cardio-surgeons and anesthesiologist for minimally-invasive surgery patients, and any other necessary physicians.
• Hotel accommodations, including breakfast and all taxes at a four star luxury hotel for all medically-necessary nights up to twenty-one for you and a companion.
• All transportation between the airport, hotel, and hospital by private car with a driver and an assigned English-speaking Patient Care Coordinator (PCC).
• Post-treatment follow-up from a Patient Care Follow-Up Coordinator (PFC). Upon your return home, you’ll receive regular phone calls from your PFC to check how you are doing and provide answers to post-treatment questions you may have.

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Because the procedure is not approved by the FDA, it is unlikely that your insurance will cover it.

Although the costs at our treating hospitals are only a fraction of what you would pay in the U.S. the VesCell™ process is relatively new and the current volume of cases (now about 40 per month) is not yet high enough to lower the cost of individual treatments. We wish that VesCell™ were cheaper, and eventually it will be. Once VesCell™ receives FDA approval it will become widely available at a price comparable to that of medicated stents. Until then, only you can decide if the treatment is worth the price.

If you consider that about 75% of our patients experience significant improvement in their quality of life then the price may not be too much to bear. Even many of the other 25% of our patients who don’t notice significant improvement feel that the treatment has stabilized their conditions and they feel better knowing that they explored every available option.

We encourage you to investigate adult stem cell therapy and provide a good starting point for your research on our References and Resources page. We also encourage you to watch the patient videos and contact our Patient Volunteers who will gladly share their experiences about their own VesCell™ treatments.

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Your Patient Care Coordinator (PCC) will meet you at the airport and take you to your hotel. Your PCC will help you register and see that you're settled into your room. Once you are comfortable, he or she will review your schedule and answer any questions you may have. Your PCC will be with you whenever you travel between the hotel and the hospital and is never more than phone call away should you have questions or need assistance.

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The entire procedure usually takes about 14 days. The actual length of your stay will depend upon which treatment you undergo and your overall physical condition.

After your blood is drawn and while you are waiting for the stem cells to be processed, you’ll have a few days to relax. If you would like to enjoy some sightseeing, your PCC can help you make arrangements.

When your stem cells return in about a week, they are immediately implanted. For the next few days, you will remain in the hospital for observation.

Your treating physician will prepare a full medical report for you to take home to your regular cardiologist.

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Please look at our Facilities page for affiliated hospitals. All treating hospitals are state-of-the-art international-standard medical facilities with dedicated heart centers that offer extensive services to cardiac patients.

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The risks involved are similar to those of a standard angioplasty or minimally invasive heart surgery. To date, VesCell™ therapy has produced no significant side effects or adverse permanent complications. However, as with any medical treatment, there may be unforeseen side effects or unanticipated complications. Therefore, TheraVitae cannot guarantee that no complications will occur.

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Once the treating physicians have received your medical information, we can arrange for a cardiologist to talk to your regular cardiologist. We also provide you with a full information packet (via email) to pass on to your doctor(s).

After a doctor with experience in VesCell™ therapy speaks to a patient's doctor and answers questions directly, the patient’s doctor will usually become much more comfortable and supportive.

Of course, once you return home, your own cardiologist will handle your follow-up care and will keep us informed of your progress.

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