Ailing hearts boosted by Israeli stem cell treatment

www.israel21c.com published one of the best articles we've ever seen on VesCell therapy this past week. The full text of the article is below.

(We would like to point out that Dr. Amit Patel's participaton was limited to acting in a supervisory and teaching role for Thai cardiologists who carried out the treatment.)

HEALTH

Ailing hearts boosted by Israeli stem cell treatment

By David Brinn December 11, 2005

Ever since she gave birth two years ago, Jeanine Lewis' heart had grown increasingly weak and enlarged, due to a condition called cardiomyopathy.

She was diagnosed with the condition at age 17, but childbirth significantly worsened her health. With each pump, her heart moved only about half the blood that a healthy heart should be circulating throughout her body.

The 29-year-old Pennsylvania resident was on the verge of despair when she found an Internet site that described revolutionary stem cell treatments for conditions like hers, and she decided to fill out the questionnaire to see if she qualified.

Two months later, she received a phone call from a representative from the company TheraVitae, who told her that the company could offer a possible solution to her problems.

In May, a team of cardiac surgeons led by Dr. Kit Arom, a renowned cardiac surgeon worldwide at Bangkok's Heart Hospital, and Dr. Amit Patel of the University of Pittsburgh operated on Lewis in Thailand, and she became the first patient in the world to have stem cells that had been harvested using TheraVitae's Israeli-developed VesCell therapy implanted directly into her heart.

"I'm not ready to run a marathon," she recently wrote on her website. "But I feel like I did before I was pregnant. That they could take something from your own body and use it to heal you, there's nothing more natural than that."

Lewis's miraculous recovery was a result of TheraVitae's novel technology which offers treatment for heart disease with stem cells taken from the patient's own blood.

The interim clinical results of the VesCell therapy were presented last month to the American Heart Association's Scientific Sessions in Dallas. According to the data, 93% of the 65 patients given VesCell treatment reported an increased ability to perform physical exercise, 62% showed improvement in treadmill exercise capacity, and 73% of patients showed an improvement in perfusion defect of the ischemic region.

"The results are a major step toward proving the safety and efficacy of VesCellTM therapy, and demonstrating the reliability of TheraVitae's cell manufacturing process. Moreover, they illustrate the considerable benefits and low risk that VesCellTM therapy provides to patients," said Dr Alex Battler, director of cardiology at the Rabin Medical Center in Israel and TheraVitae's chief medical officer, who presented the study in Dallas.

Last week, TheraVitae was named by the prestigious Geneva-based World Economic Forum as one of 36 Technology Pioneers for 2006. According to the organization, Technology Pioneers are companies that have been identified as developing and applying highly transformational and innovative technologies in the areas of energy, biotechnology and health, and information technology.

The VesCell therapy produced therapeutic adult stem cell populations using a laboratory process that isolates, further expands and differentiates stem cells that were harvested from a small volume of her own blood.

According to TheraVitae's CEO Dr. Valentin Fulga, VesCell consists of Angiogenic Cell Precursors (ACP), cells with the capacity to induce blood vessel and muscle tissue formation in the heart. Cell biologists and immunologists at TheraVitae's laboratory harvest the ACPs from blood collected in a procedure similar to a common blood donation - a stark contrast to similar therapies that require painful collection of stem cells from the bone marrow which is usually taken in large amounts from the hip bone.

"What would you prefer - somebody puncturing your bone to extract a liquid, or puncturing a vein? It's a rhetorical question, but in addition to not only being easier for the patient, it's safer. ACPs are also much easier to harvest because it only requires drawing a small amount of blood from the patient. It does not require a surgical procedure like bone marrow or muscle tissue," Fulga told ISRAEL21c.

According to Fulga, using one's own cells is advantageous because in contrast to stem cells taken from a human embryo, there are no ethical questions or political controversy involved.

Patel, who has collaborated with TheraVitae to treat many patients, said that another advantage of the technology is that there is no risk of rejection by the immune system. Patel believes that VesCell is as safe as cells taken directly from the patient's bone marrow - and safer than cells derived from muscle tissue.

"The results are very promising and we don't see the complications that we see with other cell types," he said.

According to Fulga, TheraVitae offers the treatment to any patient who suffers from end-stage heart disease and passes the medical screening process for the procedure, which is performed by the cardiologists and the cardiac surgeons in Bangkok.

"The decision about the eligibility and treatment of the patient are made by the Thai doctors. About two out of three patients who apply are accepted," he said. The cost of the procedure is $31,500 to $34,500, which includes all costs associated with the processing of the blood into stem cells, all hospital charges, all physician fees and hotel room charges for the 14-day visit to Thailand.

The process that Lewis and 64 other patients went through is like this - about 250 cc of blood drawn - less than a standard blood donation. This is sent to the company's laboratory in Israel, where the ACPs are harvested from the blood.

A week later, a batch of several million stem cells is returned to Bangkok. These are inserted by surgeons into the patient's arteries or heart.

Patel says that when the cells are released into coronary arteries using an angioplasty catheter, they appear to form new vessels and improve blood flow; when injected directly into the heart with a syringe, they seem to grow into new tissue and improve pumping efficiency.

The two-and-a-half-year-old company, based in Rehovot, also has headquarters and centers its clinical operations in Bangkok due to a number of factors, explained Fulga.

"In Thailand, and in many other countries like Germany, Greece, and Australia, treatments that are based on the patient's own cells are not regulated like drugs but as medical procedures. This means that the doctor has to decide if the treatment is worth using, if it's safe and effective," Fulga said.

"The clinical trials we performed were in order to show the medical professionals in Thailand that we had a safe and effective procedure," he added.

"Just as more importantly, there's top class medical practices in Thailand. Their medical and clinical standards are very high, both in terms of the level of medicine and their facilities. More than a million people come to Thailand for Western medical treatment every year. Combining our science and the capabilities of the Thai clinics makes perfect match," he said.

It made perfect sense to two Dallas-area men who were also among the first in the world to receive the treatment as part of the TheraVitae program being conducted in Bangkok.

Billy Bob Williams, 84, of Frisco and Dale Morrison, 68, of Richardson were part of a group of patients who have been treated for heart failure and blocked coronary arteries over the past year. Both Williams and Morrison have shown marked improvement, according to Fulga.

"We've treated 65 patients, and the number is going up daily, and we're very optimistic. Based on the data gathered, it will be much easier to get initial approval for Phase I trials in the US, which we're planning to apply for within the next few months," said Fulga.

In addition, a clinical trial to assess the efficacy of VesCell in the treatment of peripheral arterial disease is planned for the near future.

Last week, Hawaiian music legend Don Ho also underwent the VesCell treatment and is currently recovering in intensive care in the Bangkok hospital. Ho, who has entertained tourists for more than four decades, has suffered from heart problems for about a year and had a pacemaker implanted a few months ago. Ho's spokeswoman Donna Jung says her client hopes to return to Hawaii in time for Christmas, AP reported.

As the therapy is still in its early stages, only those classified by doctors as "no option" - meaning that conventional solutions such as angioplasty and bypass surgery have been exhausted - are eligible.

"We're treating patients that have no other therapeutic option. There's no pill they can take, their lives are headed in one direction. This therapy is one that can bring them in the opposite direction," said Fulga.

Fulga, is a well-known figure in the field of cell therapy, with more than 10 years of experience in the life science industry. A member of the founding team of Proneuron Biotechnologies, Inc., a cell therapy company in the field of neuroscience, Fulga brought his expertise and exuberance to TheraVitae two and a half years ago.

"Now you have me blushing," he said when told that ISRAEL21c was interested in writing about the company's achievements. "When you talk about Israeli achievements in the field of science and research, and you mention TheraVitae, then it means you think we've accomplished something. That makes me feel good."

The gregarious CEO of TheraVitae was frothing to reveal a secret, but would only say, "Keep an eye on the Internet next Monday at 11 am."

It was on that day and time that TheraVitae was given the Technology Pioneers honor by the World Economic Forum - an important international vote of confidence.

"We will continue to implement our credo: 'let the body cure itself', offering real hope to patients suffering from many hitherto untreatable diseases," said Fulga in response to the award.

For Jeanine Lewis and the dozens of other patients whose lives have been improved by this Israeli technology, that credo is taken to heart.


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