----- Original Message ----- From: Peter Irwin To: (edited for privacy) Cc: COO (edited for privacy)
Sent: Saturday, January 28, 2006 2:00 PM
Subject: Antarctica
G/day , I will be off line for 3 weeks as we will be on a cruise to the Antarctic, will be thinking of you as we freeze to death.......May be able to bring back a penguin or two,,God bless you real good..Peter Irwin.....XXXXX
We wish Esteban the best of luck and hope to see him diving again soon.
Below are excepts from Esteban's email. Some personal medical details have been removed.
----- Original Message ----- From: Esteban Bonilla To: Dr. x (dr. name edited) Sent: Wednesday, January 25, 2006 2:18 AM Subject: First follow-up
Dear Dr. X,
I hope you are doing well. I wanted to update you as fast as I could about my first follow-up appointment. I know you told me not to expect much so I really did not expect too much but then again, I was hopeful for some noticable changes. I had an Echocardiogram done this morning and from the best I could see the heart looks better than I had remembered seeing it. The function measured at the weakest measurement was now at 24%...
Most of the heart muscle that was barely pumping is now pumping, only a few areas not moving at all... I still have a lot of regurgatation from the valve... I did not get to speak with my cardiologist about what I saw but I know this for sure, I feel better, reguardless of what the numbers say...
... I walk as much as possible, usually 4 to 5 times a week and 30 to 45 minutes at a time. No palps, no pain, no real shortness of breath and no fatique. My heart rate is elevated though and that concerns me...
Dr. x, Thank you for taking the time to read my mail. All the best to you and your staff at the Heart Hospital...
Peace always,
Esteban Bonilla
Note from VesCell:Bangkok Heart Hospital treated Esteban about one month ago. Improvements due to the stem cells normally materialize approximately 3-4 months after treatment.
One of our former patients from Ohio is back in Bangkok again. He gave us a report on his progress since receiving our stem cell therapy last September. Success stories like this make us proud to be a part of this company.
From: H. D. [Original email withheld] Sent: Tuesday, January 24, 2006 12:41 PM To: Tim Subject: Hello
Dear Tim,
Hello you and all the folks at TheraVitae!I'm back in Thailand, and hope to visit the TheraVitae office soon. I just wanted to say thanks again for saving my life! The changes in my life are astounding!
Even before I returned to the states after my surgery in September, I could feel the changes in my health. I went to dinner and the movies with some ladies I met in Bangkok and generally had little chest pain, and almost no shortness of breath; and that was within two weeks of my stem cell treatment.
Once back home in Ohio, I noticed almost every day that I was doing more and more; and feeling less and less out of breath. I almost never had any chest pains and was rarely out of breath at all. While the last three months have not been completely incident free, the quality of my life has been profoundly better than that which I had the last few years.
I have been able to walk and do things that a few years ago seemed even impossible to imagine. Last week, I went to Ayutthaya, Thailand to see the old temple ruins and ride elephants. The steps at the temples in Ayutthaya are very steep, and there are a lot of them. My girlfriend (who's half my age) got winded, but I didn't!
Anyway, I have been shopping all over Bangkok, out to see the nightlife, meeting new friends, and generally living a normal life again. I cannot hope to convey the substantial feeling of wellness that I have now. It is amazing, and I can only hope that others who have weak hearts will come to Bangkok for stem cell treatment. They cannot know how much their lives will improve, and I am afraid my gushing enthusiasm only sounds like a commercial. But, I am happy to be alive again; and that's not something I could have said last year. I existed last year. I only wondered how much longer I would last, and if I would suffer at the end. I couldn't even take my dogs out to play anymore and was fairly "homebound." Guess what? My mastiffs can knock me around and jump on me all they want now! I am pretty sure they are happy their "dad" is back! I know I am happier being able to play with them and to be able to get out and do things I like to do again.
We are happy that Don Ho is performing again just 7 weeks after receiving Vescell therapy. He performed in front of 300 fans on Sunday night. Take a look at what Joe Correa says "...it may open doors for others." We agree with Joe and we hope to help more heart patients in the near future.
Don Ho's Back On the Stage Source: Honolulu Advertiser Posted on Monday, January 23, 2006
Don Ho was back crooning, wisecracking and flirting at his Waikiki showroom last night, less than two months after he underwent an experimental stem cell procedure in Thailand to strengthen his heart.
A sellout crowd of 300 at the Hoku Hale Showroom at the 'Ohana Waikiki Beachcomber Hotel welcomed back the iconic singer in his first performance since Thanksgiving Day.
Wearing white pants, a blue velvet shirt and a white ginger lei, a smiling Ho greeted people entering the showroom for the 8 p.m. show. More than 50 people queued up for a snapshot with Ho, who charmed tourists and called out to old friends by name.
When he walked onstage at 8:30, the audience erupted in a standing ovation. He sat behind an organ and immediately launched into one of his standards, "Night Life."
His signature "Tiny Bubbles" was next, and by the end of the 90-minute show Ho had sung 10 songs and earned a second standing O.
"His charisma and presence were crisp. He was sharp as a tack," said Joe Correa, a Waimanalo rancher who went to the show with his wife and some friends. "It was great to see him do what he does."
Correa said he admired Ho for having the stem cell procedure and thinks it may open doors for others.
Ho, 75, joked with the audience about being away and about his four-piece band being a little rusty, but spoke little about his medical procedure.
He said he plans to be around for another 30 years "but I'll look like hell. If you come and see me in 30 years, you'll look like hell, too."
Before the stem cell treatment in Bangkok last month, Ho had been lethargic for months. He suffered from cardiomyopathy, a serious disease in which the heart muscle becomes inflamed and does not function normally.
After a particularly difficult show on Thanksgiving, he decided to move ahead with the procedure, Jung said.
VesCell therapy uses stem cells taken from the patient's own blood. The stem cells are isolated then multiplied through a patented lab-grown process.
The cells are then inserted directly into the heart or arteries to help restore damaged tissue and ultimately regulate the patient's heartbeat.
Stem cell treatment is still under review in the United States and not allowed here. Ho, whose heart was operating at 10 percent capacity before the surgery, hopes that in the next six months he'll regain 50 percent to 75 percent of his heart's ability to pump blood.
At the end of his show last night, Ho spoke briefly about trying to get the word out about this alternative treatment.
I was getting worried about Calvin Miller, our very first private stem cell patient. I have been trying to call him since New Year's Day and I have not been able to reach him. He also has not returned any of my calls.
Well, last night he finally called me back. He's in Koh Chang (an island in Thailand) diving! I mean, DIVING!! He said that he's racked up 63 dives this trip and plans on getting in at least 20 more dives before returning to Bangkok Heart Hospital for a check up.
He promised to bring back some pictures and if he does, I'll post them on the blog for everyone to see.
I remember when he could barely walk up 2 flights of stairs.
Here is the latest on Don Ho's progress after treatment published in the Honolulu Advertiser.
Posted on: Thursday, January 19, 2006
Don Ho goes hana hou By Wayne HaradaAdvertiser Entertainment Writer
Don Ho isn't worried about how his heart will respond when he returns to the stage Sunday night in Waikiki.
It's his voice that concerns him.
"I don't know if I can sing," said Ho, 75, who underwent an experimental stem cell procedure last month in Thailand to bolster his heart muscles. "My stamina's good. I don't want to sit around and do nothing, which is why I've been trying to clean out some junk at home. But I just don't know how my voice is going to sound."
Ho long has been Hawai'i's most recognized entertainer. His experimental surgery on Dec. 5 generated headlines worldwide and gave hope to others with failing hearts. Sunday's performance, which will include his trademark "Tiny Bubbles," will be the latest step toward resumption of routine as his heart continues to improve.
"Just going back to work will be great," he said. "We'll start with one show and see how that goes."
It's encouraging to see a clinical trial on treating periperal vascular disease with adult stem cells commencing in America. We expect to start a similar trial in Thailand very soon. However, it's unfortunate that American patients will have to endure a half-liter bone marrow extraction when, in fact, a routine blood draw is all that is actually required.
Heartbeat
Tapping The Potential Of Adult Stem Cells Can adult stem cells help regenerate the damaged blood vessels in patients with peripheral vascular disease? Published: November/December 2005
A multidisciplinary team of researchers at the Indiana Center for Vascular Biology and Medicine is experimenting with a novel adult stem cell therapy, using patients' bone marrow cells that are involved in arterial formation and repair. The Stem Cell Mediated Angiogenesis Study is an FDA-approved Phase I clinical trial to examine how safe and effective adult stem cells are for stimulating the development of new blood vessels in the legs of patients with severe peripheral vascular disease--a painful condition that, according to the American Heart Association, affects approximately 12 million people. When blocked or destroyed, arteries in the leg are unable to transport essential nutrients and oxygen, resulting in tissue death and gangrene. Many patients suffering from advanced peripheral vascular disease often exhaust all conventional means of therapy and face amputation.
Researchers hope that the specialized adult stem cells--known as endothelial progenitor cells (EPCs), involved in the repair of the inner lining of blood vessels--will help restore enough blood flow to lower limbs to help regenerate blood vessels and avoid amputation.
One day, the innovative therapy might benefit other areas of the body, such as the heart muscle.
To learn more about the trial, the Post spoke with Michael Murphy, M.D., at the Indiana Center for Vascular Biology and Medicine at Indiana University School of Medicine.
Post: Could you outline your research utilizing adult stem cell-based therapy to treat cardiovascular disease?
Murphy: Basically in the last five years, researchers have isolated a cell in the bloodstream of humans called an endothelial progenitor cell--a special type of stem cell. Subsequent studies have demonstrated that the endothelial progenitor cell, or EPC, comes from the bone marrow. Clinical evidence from an NIH study showed that patients who have a greater number of cardiovascular risk factors--high blood pressure, diabetes or cigarette smoking--have fewer endothelial progenitor cells. The conclusion was that these cells are involved with arterial repair and may help prevent the development of atherosclerosis. The cells also participate in the development of new blood vessels. Animal studies have demonstrated that when EPCs from bone marrow are injected into lab animals, they develop new blood vessels in response.
Post: How do you retrieve and administer the adult stem cells in your study?
Murphy: Under anesthesia, we remove about 500 cc, or one-half a liter, of bone marrow from the patient--about 2 to 2 1/2 cups of bone marrow. We process the bone marrow in our stem cell laboratory at University Hospital. We separate out what we call the buffy coat--the mononuclear cell layer--by spinning the cell preparation at very high speeds.
To administer, we basically inject the cells, or the mononuclear cell fraction containing a subpopulation of progenitor stem cells, right into the calf muscle of the affected leg that has insufficient blood flow. In the future, we plan to grow the cells in culture and increase the number of endothelial progenitor cells before injecting. Right now, we have strict limitations on what we can do from the FDA, because this is the first such study in the United States.
There is evidence the injected progenitor ceils directly incorporate into new capillary beds and produce the necessary protein messengers--so-called cytokines--that induce existing blood vessels to grow.
By using the cells from the patient's own bone marrow, we avoid the problem of rejection and so avoid the ethical issue of using embryological cells.
Pacific Business News (Honolulu) - 9:21 AM HAST Tuesday
Don Ho to perform again Don Ho, who had experimental stem cell surgery in Thailand last month to improve a weakened heart, will return to performing this month.
The Don Ho Show at the Ohana Waikiki Beachcomber Hotel will resume on Sunday, Jan. 22. "At this time the show schedule will be Sundays only," a spokesman for the performer said Monday. "At some future date the previous schedule of Sunday, Tuesday, Thursday will be resumed."
The 75-year-old entertainer underwent a procedure that is not yet approved in the United States.
"I feel great and I look forward to getting back to my show on January 22," said Ho.
We received the following email from one of our patients who was treated in early October last year. After first considering a heart transplant, she ultimately decided to undergo the less complicated stem cell procedure. Her heart condition has improved to the point where she can now take short walks with her son again. Her renewed hope is an inspiration to us all.
From: "M.L.C" (original email withheld) To: Don Margolis Sent: Friday, January 13, 2006 9:52 PM
I was in the city for an appointment with Dr. B, head of orthopaedics at C. Presbytarian. I started seeing him last year due to both shoulders being frozen. He was shocked at my progress, told me I was cured and that he felt it was possibly related to the stem cell therapy. He has now concluded that the shoulder problem I had was directly related to inflamation from the heart situation. Anyway, after I left his office on East 60th St., I walked down 5th Ave. to 42nd St. and over a block to meet my son-in-law at the Chrysler Bldg. so that we could take the ferry home. Definitely better than a "15" (EF, that is). By the way, Dr. B was quite excited about the stem cell procedure and he wrote down the name of your company. M
Source: National Review Online by Kathryn Jean Lopez January 12, 2006, 8:20 a.m.
A Hyped “Hero” Falls
And we get a second chance to preserve the dignity of human life.
When it comes to cloning, all anyone can talk about lately — and understandably so — is recently disgraced South Korean scientist Hwang Woo-suk. One of Time's most influential people of 2004 could prove to be one of the most influential people of 2006, too — but in ways he never intended.
Hwang, whose cloning claims have been unraveling in recent weeks, has been exposed as a liar. At first, he delusionally thought he could save himself from public disgrace, trying to talk his way out of revelations about unethical egg-procurement practices. But soon we learned that he faked research, too — even though he tried to claim innocence and cry sabotage. And before 2005's end we learned that in his most celebrated "success," Mr. Stem Cell had never, in fact, created any embryonic stem cells from cloned embryos.
This is actually good news. Cloning — even under frequently used euphemisms: somatic-cell nuclear transfer, therapeutic cloning, and simply "stem-cell research" — would be a giant leap for mankind, and not a good one. To create a life in order to destroy it, as so-called therapeutic cloning would do, is a brave new world for us. A world that, although some states even here have already invested money in pursuing, we have not quite arrived at. Phew.
For the medical community, public policymakers, and investors this is a perfect moment for a collective deep breath, considering these Hwang revelations. (Investors are sometimes you and me in states where such research is publicly funded, including California, Massachusetts, and New Jersey). It's a perfect moment for everyone to start to really pay attention. And to consider that perhaps the road currently less traveled, less reported on, and less invested in may be the one to go down with a new enthusiasm.
The aforementioned road involves alternatives to embryonic-stem-cell research and cloning, namely adult- and umbilical-cord-stem-cell research. Hawaiian singer Don Ho, who was suffering from a weakened heart muscle, says that he could barely walk, never mind sing. Ho underwent an experimental stem-cell surgery in Thailand in early December. "I'm feeling terrific, 100 percent better," Ho told the Associated Press in a pre-Christmas interview.
Ho's help involves multiplying stem cells taken from the patient's blood and injecting them in the heart. The idea is to strengthen the heart muscles. The procedure, which was developed by a professor at the University of Pittsburgh Medical Center, is not currently approved for use in the United States.
Ho's story is anecdotal, but it's but one of many apparent and real successes of late to come from adult- and umbilical-cord-stem-cell research — the kind that is free of the heavy and culture-redefining ethical baggage that comes with embryonic-stem-cell research and cloning.
We received this email from a patient on January 10th (names and phone numbers have been edited):
I just came back from my visit to Dr. B. He was very pleased with the way I look-- great color and how I feel. He is going to give me a halter monitor for a day starting this afternoon. He detected some irregularities with the heart beat. He said that the differences in the EF ffraction will vary from test to test and day to day. Not too worry about it though.
He will be available for a phone call Monday through Thursday around 8 A.M. Dr. B's phone number (xxx) xxx-xxxx.
He lowered the nitro patch from .4 to .2 He also said to try going without it for several days. Overall he is very pleased with everything. When I told him I was walking 2 miles a day he said you couldn't walk 20 feet before.
Here is an interpretation of some interesting results that were published in The Lancet this month. The abstract of the study can be viewed online here. (you must register with www.thelancet.com to view the article)
This week, doctors at the Catholic University of Leuven, connected with the University Hospital - Gasthuisberg, the Stem Cell Institute Leuven (SCIL), and the Flanders Interuniversity Institute for Biotechnology (VIB), are publishing a major breakthrough in the treatment of patients with acute myocardial infarction. Their research shows that the administration of a patient's own stem cells has a significant positive effect on the heart's recovery: in the patients studied, the size of the infarct was clearly reduced. The use of stem cells appears to be safe, and to date no side effects have occurred that can be attributed to the stem cells. This study is a world-first − its exciting results are being published in the prominent medical journal The Lancet.
In an acute myocardial infarction, the flow of blood from a blood vessel in the heart is blocked, whereby the cardiac muscle receives insufficient oxygen and heart tissue dies. In many cases, the supply of blood in the deadened portion of the heart can be restored via the so-called balloon technique. But the heart suffers permanent damage, primarily to the left ventricle.
The researchers in Leuven have tested the administration of bone marrow stem cells on patients stricken with acute myocardial infarction. In the 67 patients of the study, the supply of blood in the heart was restored optimally via the balloon technique. Then, within 24 hours, some patients received an injection of stem cells from their own bone marrow and some received an aqueous (placebo) solution (the patients in each group were selected by drawing lots). Such a double-blind, placebo-controlled study has never before been conducted.
Collaboration among the cardiology, hematology, radiology and nuclear medicine services yielded an unparalleled study in which state-of-the-art technology was used to investigate changes in the left ventricle, blood supply and heart metabolism.
Improvement in the global functioning of the left ventricle was comparable in both the control group (injected with the placebo) and the group that received the stem cells. But a clear global improvement in function was found in the sub-group of patients who had been afflicted with the most serious infarctions. Moreover, the reduction of the size of infarct was significantly greater in all patients in the 'stem cell group' and correlates with a better preserved regional left ventricle function. It is still much too early to conclude that every patient with a myocardial infarction should be treated with stem cells. Indeed, there is still a long road to travel in the development of a medication, and no risks must be taken along the way.
One of the major scientific merits of this study is that it has investigated − in a rigorously controlled manner − the possible role as well as the limitations of the administration of stem cells. The findings are thus an important driving force for further targeted clinical and pre-clinical research. This study is the initial impetus for VIB and the Catholic University of Leuven and the newly established SCIL to quickly combine fundamental research on stem cells with clinical applications for the benefit of patients.
From VesCell: We've made a habit of under-promising and over-delivering for good reason. Below is a heart-breaking example of how over-promising and under-delivering can devistate good, honest people - even children.
Many in the medical establishment accepted Dr. Hwang's scientific "evidence" regarding embryonic stem cells with alacrity because he was telling them what they wanted to hear. These are the same people who choose not believe any medical facts we provide to them regarding patients improving after receiving adult stem cell therapy to treat heart diseases such as dilated cardiomyopathy. (They won't even believe before and after MRIs) Go Figure!
Hopes Founder on 'Big Lie'
Scientific scandal has shattered the vow made by a South Korean veterinarian that cloned stem cells would help a paralyzed boy walk.
By Barbara Demick, Times Staff Writer
SIHEUNG, South Korea — The boy who became known as "Donor 2" was propped up in a wheelchair when a team of esteemed scientists strolled into his hospital room nearly three years ago.
Nine-year-old Kim Hyeoni had been hit by a car while crossing the street the previous year. Once a chubby-cheeked child who loved baseball and practical jokes, he now was paralyzed from the chest down.
"Sir, will I be able to stand up and walk again?" he asked the leader of the team, a South Korean veterinarian named Hwang Woo Suk, according to an account by his father.
"I will make you walk. I promise," replied Hwang, who would soon afterward announce a breakthrough in the cloning of human stem cells.
With that meeting in April 2003, Hyeoni in effect became a poster boy in the quest to use cloned stem cells for experimental treatments of spinal-cord injuries.
His father, a Methodist minister, defied the beliefs of many of his fellow church members and allowed Hwang to cut skin samples from his son's abdomen for the research. Hyeoni's mother, a nurse, volunteered for the invasive procedure of having her eggs extracted to donate to Hwang's laboratory.
Now the family is faced with the sinking realization that "it was all a big lie," said Kim Je Eon, the boy's 43-year-old father.
The family's saga captures at its most vivid the disappointment felt by millions around the world.
Not only has much of Hwang's work proved to be a fabrication, the scandal surrounding him is believed to have set back legitimate research for years.
We've just received this email below from one of our patients; an Australian who recently underwent stem cell treatment. Let's see what he says:
-- Original Message ----- From: Peter Irwin (original email address withheld) Sent: Thursday, January 05, 2006 8:49 AM Subject: Fw: M.R.I.
Hi Friends, Finally got the result.... 33% E.F. according to M.R.I. 22/12/05., not as good as I thought, however it is still a big improvement on 21% prior to op and I believe it has increased in the last 2 weeks since the M.R.I. ......So I am happy with that.....I have been feeling well most of the time, still with some limitations but the expectation was always for improvement rather than a complete restoration of the heart muscle..I may still require a defibrillator to assist the heart beat but I believe that improvement will continue and God will continue to restore me and keep me, one day at a time.......Peter Irwin....
We received the following email from Esteban Bonilla regarding his recent trip to Bangkok for VesCell stem cell therapy to treat his heart failure. Just this morning, Reuters released a story about Mr. Bonilla's trip as well.
----- Original Message ----- From: Esteban Bonilla (email link removed) To: Don Margolis Sent: Wednesday, January 04, 2006 4:13 AM Subject: Hi Don Hello Don,
Thank you again for the time you gave me in Bangkok! I can say that I have never felt this good in a long time and I got to spend a few days in PA with Jeannine and family. I am back in Florida now and the weather has been good. I walk every morning and I try not to over do anything at this point. I am still sore on my left side but hey, small price to pay for such a tremendous operation! :)
Anyways, I know you are busy but please tell Bell and Jitra and Sak all is well with me. Take care Coo and I hope we meet again soon.
Peace always,
Esteban Bonilla
FEATURE-Stem cell therapy sparks hope in ailing hearts 05 Jan 2006 01:01:51 GMT Source: Reuters
By Chawadee Nualkhair
BANGKOK, Jan 5 (Reuters) - Esteban Bonilla feels no trepidation as he is wheeled into the operating room of a Bangkok hospital, despite the fact he is only minutes away from starting an experimental stem cell procedure he hopes will keep him alive.
"I really don't feel nervous at all," said the 37-year-old scuba instructor from Florida, who discovered his heart was failing at 32. "For the last five years, I've been waiting to die. This is the first time I've been hopeful to live."
The source of Bonilla's new-found hope is a novel therapy that involves injecting stem cells culled from the patient's own blood into the heart to try to regenerate ailing heart muscle. The two-hour procedure, which involves a patient's own adult stem cells, skirts the risk of rejection by the body and thorny ethical issues surrounding the use of embryonic stem cells posed by some who equate using embryos with destroying human life.
"We have not lost a single patient," said Suphachai Chaithiraphan, chairman of Chao Phya Hospital and president of the Heart Association of Thailand. "If you can offer help to desperate people, then I think you should."
The destination for many of the heart patients seeking stem cell therapy is Thailand, where doctors have staked their reputations on a procedure they say could save thousands of people but has yet to be approved in the United States.
"With stem cell therapy, people who have not had access to heart transplants or resources to go to the hospital on a regular basis can be helped," said Kitipan V. Arom, chief cardio-thoracic surgeon at Bangkok Heart Hospital.
Here is an AP article that just appeared online about the progress of Marie Carty, a patient treated last October with VesCell using throracoscopic injection at Bangkok Heart Hospital.
4 January 2006
JERUSALEM - After 61 years of pumping blood, Marie Carty’s heart was failing her. Months earlier she had given up her two-mile (three-kilometer) walk on her hometown boardwalk along the Atlantic Ocean. Now she could barely make it from the parking lot to the view of the water.
Although Carty knew she needed a new heart, she was afraid hers wouldn’t last during the long wait for a transplant.
Desperate for an alternative, Carty found the Israeli-Thai company Theravitae, which has begun performing an extraordinary though still experimental procedure that multiplies stem cells taken from a patient’s own blood and injects them into the ailing heart in hopes of strengthening it.
The procedure performed by Theravitae and a handful of other companies could offer new hope to hundreds of thousands of heart patients around the world.
The US Food and Drug Administration has not yet approved the procedure for use in the United States, and though doctors hope it can be a substitute for heart transplants, the permanence of the repairs has yet to be ascertained.
“It’s too early to know the long-term effects of these types of procedures,” said Vincent Pompili, director of interventional cardiology at Case Western Reserve University in Ohio.
Several teams of doctors around the world _ including at least three in the United States _ are currently conducting similar research trials that they say show promising results, using stem cells extracted from bone marrow. Proponents of Theravitae’s newer procedure using stem cells from blood say it is simpler and less painful than extracting cells from bone marrow.
The procedure involves no risk of rejection since the cells are the patient’s own. It also does not use embryonic stem cells; employing these have raised moral objections since they require the destruction of human embryos.
After a two-week trip this fall to Thailand for the operation, Carty is once again walking two miles (three kilometers) on the boardwalk in her hometown of Little Silver, New Jersey _ and she is no longer a candidate for a transplant.
“There was no other option for me,” said Carty, who works in property management. “The change is like night and day. I feel myself again, more energy, more stamina.”
Carty is one of 70 people who have undergone Theravitae’s procedure, said Valentin Fulga, CEO of the company. All have shown improvement, he said.
The list also includes Hawaiian crooner Don Ho, who underwent the operation in early December in Thailand.
“I’m feeling much better and I’m so happy I came up here to do it,” the 75-year-old entertainer said in a statement after the procedure.
Fulga said patients who get the surgery are generally heart transplant candidates or people who have undergone bypass surgery without positive results.
“We believe that these cells have the capacity of turning into blood vessels,” Fulga said. “The treatment seems to be not only very safe, with no side effects, but also effective because they improve.”
Fulga acknowledges that with only 1 1/2 years since the company’s first operation, there’s still a lot to learn. Over time, he said, the cells that repair the heart could lose their effectiveness.
Fulga said it is not known exactly how the cells inserted into the heart actually improve the patient’s condition. But it is believed they help reconstruct blood capillaries and vessels and the heart muscle itself, capitalizing on the body’s natural healing processes, Fulga said.
The treatment involves withdrawing blood from a patient and placing it in a centrifuge to separate out _ by weight and size _ a group of cells needed for the procedure. This batch of cells, called VesCell by the company, is composed of stem cells and other cells beneficial to the process.
Fulga and Thai entrepreneur Robert Clark founded Theravitae in 2003. Patients travel to Thailand for the extraction of the blood and wait less than a week while it is sent to Israel. There the stem cells are harvested and expanded and then shipped back to the Thai hospital where the operation to insert them is performed.
The total cost is about $35,000 (Ð29,000) , including airfare and lodging, Fulga said. Fulga said he expects to meet FDA officials within six months with the hope of getting approval to begin conducting trials in the United States.
Mark Zucker, director of Heart Failure and Transplantation at Newark Beth Israel Medical Center in New Jersey, said therapy using adult stem cells is the way of the future. His center is considering beginning work with Theravitae.
If doctors at Theravitae have discovered how to make stem cells heal heart tissue, Zucker said, this could be a real solution for tens of thousands of Americans, since only 2,300 hearts become available for transplantation in the United States each year.
“I believe Theravitae is on the right track,” Zucker said. “I think if the company has identified an efficient way to procure cells and expand them, the company’s impact will be revolutionary.” The company presented its findings at a conference of the American Heart Association in Dallas, Texas, in November. It has been chosen along with 35 other companies as a technology pioneer for 2006 by the World Economic Forum.
Pompili, of Case Western Reserve University, said he was working through a company called Arteriocyte on a similar procedure harvesting stem cells from bone marrow. He said his company and two other teams of doctors in the US were conducting Food and Drug Administration trials using stem cell therapy to heal heart tissue.
Many scientists believe stem cells could herald a new era of regenerative medicine, leading to cures for conditions from diabetes to Parkinson’s. Research with embryonic stem cells has raised opposition in the United States, where the government limits funding for the research.
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