FIRST ever cardiac stem cell injection…um…not really! Finally, a retraction!

SO, here is the real deal.  After only 98,000 news sources and over 4,300 blogs picked up the news that this was…

“THE FIRST EVER CARDIAC STEM CELL INJECTION!!”

…there was FINALLY a retraction.  Turns out, the procedure was unique only because  they used “a pure population of stem cells, the c-kit-positive cells.”

[I liken this to inventing a car that runs on hamburgers and printing the headline: FIRST EVER CAR INVENTED! and then retracting it later with: "oops, we meant, first car to run on hamburgers."]

You have to ask yourself…Was this accident (in light of the thousands of cardiac patients already treated with stem cells around the world and the many US and international cardiac stem cell clinical trials detailed in previous articles), truly an accident or an attempt at hyping a story with the knowledge that NO ONE would see the retraction…NO ONE except for those reading my blog, that is!

I’ll keep em honest if at all possible and continue to give you the straight dope ’cause, after all….who else will?  -dg

p.s.  there are 731 scholarly articles listed under the search terms “c-kit-positive stem cell heart”, 884 under “c-kit-positive stem cell cardiac.”  I don’t have time to check them all but who wants to bet there have been multiple studies in the world using c-kit-positive injections and maybe some in the US as well?

Correction to Earlier Release From Jewish Hospital and University of Louisville

LOUISVILLE, Ky., July 24 /PRNewswire-USNewswire/ — In today’s announcement regarding the use of stem cells in the treatment of heart failure, we failed to make a critical distinction. Louisville researchers and physicians have performed the world’s first phase-one FDA-approved clinical trial using “c-kit-positive” adult cardiac stem cells to treat heart disease. The clinical trial is being conducted by a team of University of Louisville physicians at Jewish Hospital, in collaboration with Dr. Piero Anversa and his team at the Brigham and Women’s Hospital in Boston.

Following the press conference Roberto Bolli, Jewish Hospital Heart and Lung Institute Distinguished Chair in Cardiology and Director of UofL’s Institute for Molecular Cardiology, stated, “Another clinical trial is being conducted at another facility. The difference between what we have done and what another institute nationally has done is that we have injected a pure population of stem cells, the c-kit-positive cells. The other institution injected cardiosphere-derived cells, which are a mixture of primitive and partially differentiated cells, complicating the recognition of the actual therapeutic cell. Our study involves a specific, well-characterized population of undifferentiated cells: the c-kit-positive cardiac stem cells are self-renewing, clonogenic and multipotent, which are the fundamental properties of stem cells.”

This is a small, but distinct difference than the procedure performed last month in California.

We regret any misunderstanding or confusion.

FIRST EVER STEM CELL HEART PATIENT??

No, not the first.  For the record (and this is just scratching the surface):

1.  It’s all complete B.S. of course…as detailed here:

http://repairstemcell.wordpress.com/2009/07/28/worlds-first-adult-cardiac-stem-cell-is-complete-horsepuckey/

2.  They conveniently left out of the headline that this was “the first FDA approved US located clinical trial”.  The US medical media is great at painting US medical achievements as firsts when in reality, they are 6 yrs behind the rest of the world on stem cell treatments.

3.  Don’t believe it? Here’s the story about my friend James Eilert…treated OUTSIDE THE US in November 2007 -  http://repairstemcell.wordpress.com/2009/07/28/how-people-no-longer-have-to-die-from-heart-failure/ You will also see his remarkable recovery detailed in the (next?) issue of Men’s Journal.

4.  Even with the clarification of #2, someone forget to tell about all those other FDA approved studies underway, like Texas Heart, Vanderbilt, etc.

5.  These from our friend over at Adult Stem Cell Awareness:  This is not the first time a cardiac patient has been treated with stem cells – see: Stem Cells Treat Heart Attack Patient, Adult Stem Cells Better Choice Than Death or Transplant for Heart Failure Patients, Stem Cells Gave Don Ho 15 Extra Months to Perform

6.  And let’s not forget the completed clinical trials at http://clinicatrials.gov

Here are just 5 (completed trials) out of 318 when “heart stem cell” is searched:

********Stem Cell Mobilization to Treat Chest Pain and Shortness of Breath in Patients With Coronary Artery Disease – http://clinicaltrial.gov/ct2/show/NCT00043628?term=stem+cell+heart&rank=4

********Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Intra-Coronary Stem Cell Infusion-3-DES – http://clinicaltrial.gov/ct2/show/NCT00291629?term=stem+cell+heart&rank=32

********Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia – http://clinicaltrial.gov/ct2/show/NCT00260338?term=stem+cell+heart&rank=35

********Bone Marrow Stem Cell Mobilisation Therapy for Acute Myocardial Infarction (AMI)(REVIVAL-2) – http://clinicaltrial.gov/ct2/show/NCT00126100?term=stem+cell+heart&phase=3&rank=8

********The Effect of Mobilized Stem Cell by G-CSF and VEGF Gene Therapy in Patients With Stable Severe Angina Pectoris – http://clinicaltrial.gov/ct2/show/NCT00135850?term=stem+cell+heart&rank=43

********Endothelial Progenitor Cells and Nitric Oxide in Cardiac Rehabilitation Program Participants – http://clinicaltrial.gov/ct2/show/NCT00308633?term=stem+cell+heart&rank=50

and this is one of my favorite…

********Stem Cell Study for Patients With Heart Disease – http://clinicaltrial.gov/ct2/show/NCT00081913?term=stem+cell+heart&rank=58

With more info included here:

http://www.ncbi.nlm.nih.gov/pubmed/17562958?dopt=Abstract

1: Circulation. 2007 Jun 26;115(25):3165-72. Epub 2007 Jun 11.

Intramyocardial transplantation of autologous CD34+ stem cells for intractable angina: a phase I/IIa double-blind, randomized controlled trial.

Losordo DW, Schatz RA, White CJ, Udelson JE, Veereshwarayya V, Durgin M, Poh KK, Weinstein R, Kearney M, Chaudhry M, Burg A, Eaton L, Heyd L, Thorne T, Shturman L, Hoffmeister P, Story K, Zak V, Dowling D, Traverse JH, Olson RE, Flanagan J, Sodano D, Murayama T, Kawamoto A, Kusano KF, Wollins J, Welt F, Shah P, Soukas P, Asahara T, Henry TD.

Feinberg Cardiovascular Research Institute, and Department of Medicine, Northwestern University Feinberg School of Medicine and Northwestern Memorial Hospital, Chicago, IL 60611, USA. d-losordo@northwestern.edu

BACKGROUND: A growing population of patients with coronary artery disease experiences angina that is not amenable to revascularization and is refractory to medical therapy. Preclinical studies have indicated that human CD34+ stem cells induce neovascularization in ischemic myocardium, which enhances perfusion and function.

METHODS AND RESULTS: Twenty-four patients (19 men and 5 women aged 48 to 84 years) with Canadian Cardiovascular Society class 3 or 4 angina who were undergoing optimal medical treatment and who were not candidates for mechanical revascularization were enrolled in a double-blind, randomized (3:1), placebo-controlled dose-escalating study. Patients received granulocyte colony-stimulating factor 5 microg x kg(-1) x d(-1) for 5 days with leukapheresis on the fifth day. Selection of CD34+ cells was performed with a Food and Drug Administration-approved device. Electromechanical mapping was performed to identify ischemic but viable regions of myocardium for injection of cells (versus saline). The total dose of cells was distributed in 10 intramyocardial, transendocardial injections. Patients were required to have an implantable cardioverter-defibrillator or to temporarily wear a LifeVest wearable defibrillator. No incidence was observed of myocardial infarction induced by mobilization or intramyocardial injection. The intramyocardial injection of cells or saline did not result in cardiac enzyme elevation, perforation, or pericardial effusion. No incidence of ventricular tachycardia or ventricular fibrillation occurred during the administration of granulocyte colony-stimulating factor or intramyocardial injections. One patient with a history of sudden cardiac death/ventricular tachycardia/ventricular fibrillation had catheter-induced ventricular tachycardia during mapping that required cardioversion. Serious adverse events were evenly distributed. Efficacy parameters including angina frequency, nitroglycerine usage, exercise time, and Canadian Cardiovascular Society class showed trends that favored CD34+ cell-treated patients versus control subjects given placebo.

CONCLUSIONS: A randomized trial of intramyocardial injection of autologous CD34+ cells in patients with intractable angina was completed that provides evidence for feasibility, safety, and bioactivity. A larger phase IIb study is currently under way to further evaluate this therapy.

Publication Types:

• Clinical Trial, Phase I
• Clinical Trial, Phase II
• Comparative Study
• Randomized Controlled Trial
• Research Support, N.I.H., Extramural
• Research Support, Non-U.S. Gov’t

PMID: 17562958 [PubMed - indexed for MEDLINE]

—————————————-

First? No, not the first.  Probably up in the thousands by now. – dg

How People No Longer Have To Die From Heart Failure

JAMES - BACK FROM NEAR DEATH

Adult Stem Cells Healed My Heart –

My Story of Tragedy and Ultimate Victory over My Condition

BY JAMES EILERT
JULY 27, 2009

When I was 27 years old I was a bodybuilder, 200lbs of solid muscle I worked out at the gym 6 days a week every day after work. Then the first of a series of medical problems happened, I completely destroyed one of my lumbar discs l5-s1. Three years later I also destroyed the disc above it l4-l5 and suffered from severe nerve damage to my legs. The nerves did eventually grow back but I suffered from excruciating leg cramping and spasms in my feet and calves for the next four years. It was hell to even sit down for my job, needless to say I stopped exercising and due to a very poor diet and 8 cans of mountain dew a day my weight jumped up to 280lbs. I started smoking because for a few minutes the spasms quite and gave me a little peace, this allowed me to work an extra 10 hours a week and I became hooked.

Four years later at age 34 after spending two years working 80 hour weeks at a very stressful job I was working the Chrysler plant in belvidere ill. I woke up in the middle of a heart attack, not knowing what it was I walked around my hotel room for the next 45 minutes until I realized the pain wasn’t going away.

The paramedics took me to the hospital and I was sent to surgery, when I woke up the doctor informed me that I had a widowmaker – 100 blocked LAD and they had determined that 50% of my left ventricle was not moving any more. They told me that more often than not people usually don’t make it very long after one of these.

During rehab I worked very hard, finally being able to jog slowly up to two miles, but I could never get beyond that and that combined with going back to my job left me a shell of a man. Crashing from exhaustion on the couch every night and spending my weekends in bed trying make it through the next week of work. During this time my leg pain did go away, and with a good diet I dropped 90 lbs over the next 6 months.

Then the other shoe dropped, a CT was done on my chest and it was discovered that I had not only a pulmonary embolism, but I also had a giant branchial carciniod tumor that completely filled up the cavity occupied but my right middle lung. During my stay for those issues a team of cardios also looked after me. they told me at best I had maybe 5 years left if I was lucky and the very good transplant surgeon that would crack the right side of my chest gave the same chances of making threw the lobectomy as an 80 year old man.

Well I ended up being so stable during the surgery he worked an extra 2 hours on me and I recovered. I did have a bought with pneumonia also but I survived that as well.

1 ½ after my heart attack I went to Thailand for my stem cell therapy.

Before I left I had a metabolic stress test done using the advance haskell protocol. I scored 8 mets with a vo2 of 28.

40% of my left ventricle was totally dead – mri mapping

Three days after my stem cell implantation I started walking through Bangkok again, my breathing had improved, my stamina was up, and for some reason I was really hungry all the time.

Before the treatment after walking it would take half and hour in air conditioning to stop sweating and my hr would be 110 to 120 for quite while cooling down.

In three days when I tried again my hr was 85 and I would stop sweating in 5 minutes. A week and a half later I had an echo done before I left and the bottom of my heart was very weakly beating again. This really gave me hope.

Two months later I did another metabolic stress test using the standard Bruce protocol and I scored 10.1 mets with a vo2 of 32. A 20% and 12.5% increase the doctor that had done my last one blurted out “absolutely stunning!” this put me in the 95th percentile for men my age of 37 years old, in other words out of a 100men my age 50 of them could not match my performance. If I lost 50 lbs then I would be way over the average.

Now 18 months later only a very small part of the bottom of my heart isn’t beating normally and I can do nearly everything I want to now. The only thing I have not done is hard sports because I still have a fear of maxing out my heart rate – old fears die hard.

All of my body chemical stats are now in normal range, I have maintained a cholesterol of 144 total without using any statins – I quite those several months ago.

The last three weeks of july I have worked over 90+ hours and I don’t feel especially tired

My last bike ride on a recumbent bike I rode 33.5 miles in 2 hours 20 minutes.

I can walk 5 miles on a whim, and not have to relax afterwards

I did a six minute walk test and I did 804 meters in 5 minutes which is on video

The next video I make I will attempt to do 1100 to 1300 meters in 6 minutes. – what else can I say.

Adult stem cells work. No placebo effect can change the physiological effects of heart failure that are easy to see and impossible to mask.

Sincerely,
James Eilert

This is one reason this cause is so important. A class III heart patient could never lift half their body weight even once without some form of easily identifiable symptoms. They would be short of breathe, gasping, not able to talk normally, and sweating profusely, lastly they would have to sit down and wait for their heart to catch back up. As you can see I lift eight 135lb batteries with no symptoms what so ever 1 1/2 years after my adult stem cell therapy.

“World’s First Adult Cardiac Stem Cell Treatment” is complete Horsepuckey!!

“World’s First Adult Cardiac Stem Cell Treatment” is complete Horsepuckey!!

In the last week there were over 5,000 articles repeating the same ground breaking news:     “…the world’s first recipient of adult cardiac stem cells to treat congestive heart failure…”   and   “…physicians performed the world’s first cardiac adult stem cell infusion procedure…”

with all due respect to the accommplishments of the doctors…

THIS IS COMPLETE B.S.!!

..

READ CAREFULLY!

ADULT STEM CELLS HAVE BEEN USED TO TREAT CARDIAC DISEASES, INCLUDING CONGESTIVE HEART FAILURE, FOR OVER 5 YEARS!!

…

Allow me to give you the briefest history of adult stem cell cardiac history.

1998 – Dr Doris Taylor takes stem cells from the thigh of a rabbit, injects them into scar tissue in the animal’s heart and repairs the damaged muscle.  The research was published in Nature Medicine.

1998-1999 – French researchers transplanted muscle cells into a human heart.

2000 – Human studies and trials using adult stem cells to regrow muscle tissue, including cardiac muscle tissue, are performed in many countries around the world.

2002 – Dr Taylor herself witnessed in Rotterdam the first patient in the world to get stem cells injected through a catheter into the wall of the heart. Encouraging results began to come in—improved ejection fractions, reduced diameters, thicker muscle tissue.

AND NOW FOR THE REAL DEAL:

2004 – The first-ever commercial stem cell treatment center in the world starts adult stem cell treatment of hundreds of human patients.  Results are amazing and include the regrowing of cardiac muscle tissue in patients, significant increases and sometimes a doubling of ejection fractions (the % volume of blood the heart can pump out per beat), etc!  Stem cells are also recognized as “smart,” going to where they were needed most, creating micro-vessel bypasses around existing blockages areas, areas that previously were blocked and in areas where stents were implanted.

2005 – Advancements continue as Dr Taylor rinses rat hearts with detergent until the cells washed away and all that remained was a skeleton of tissue translucent as wax paper. She then injected the scaffold with fresh heart (stem) cells from newborn rats.  Four days later, “We could see these little areas that were beginning to beat.  By eight days, we could see the whole heart beating.”  The experiment, reported in the journal Nature Medicine, marked the first time scientists had created a functioning heart in the lab from biological tissue.

2007 – Anecdotal aside:  In November 2007, my friend James Eilert was treated via catheter using his own adult stem cells.  In his own words:

In Jan 2006, when I was 34 years old I had a “widowmaker,”100 % blockage of the left ascending coronary artery. My ejection fraction (EF)was between 20 and 25 percent (55 is normal) and I was told that I had about 5 years left.

1 1/2 weeks after (treatment) I had an echo done and the completely dead apex was beating again – verrrrry weakly but it was moving.

6 months later- my sidewalls are now beating normally, my septum went from 100% damage to 30% damage. My Dr. says my heart is 50 percent more elastic than the year before adult stem cell therapy.

After 6 months – My total dead heart tissue is down to about 10 percent – and my EF is up to 50 percent!

James’ heart and health continues to improve and he pushes himself and his limits today.  He runs regularly, can bike 20 miles and was recently interviewed and tested by Men’s Journal for an article to be in a future issue.

Summation:

James went from Class III congestive heart failure to Class I with an ejection fraction (EF) increase from ~20-25% to his current EF of 50%.  His doctors have lifted all restrictions and limitations on his physical activities.  Videos of his tests and results can be found on his facebook page. For more on his story, read the article to the left.

James is only one of many adult stem cell treatment success stories.

2009 – Present day.  There are currently dozens of stem cell treatment centers around the world (on at least 4 continents) who are using adult stem cells to treat cardiac disease in human patients and regrow both cardiac and skeletal muscle tissue and more. The Repair Stem Cell Institute tracks all of these treatment centers and ranks their quality and protocal effectiveness http://repairstemcells.org

To read more about cardiac stem cell successes:

More cardiac stem cell success stories: http://donmargolis.com/blog/index.php?s=cardiac

CATCH UP! – 12 MORE Articles about so called “revolutionary” cardiac stem cell advances that are 4-6 years behind the times.

There are also over 400,000 scholarly papers on the use of adult stem cells to treat heart disease, many studies and a number of clinical trials.

First ever, indeed!

Injured Troops Turn To Air Force Acupuncture Clinic : NPR

acupuncture for pain

by Stephanie Marudas

July 21, 2009

U.S. military doctors have traditionally relied on painkillers and other Western medicine to treat injured soldiers. But one branch of the armed forces is leading the way in using acupuncture to help soldiers manage chronic pain.

You can listen to the entire broadcast on NPR here:

http://www.npr.org/templates/story/story.php?storyId=106835768&ft=1&f=1066

World’s First Cardiac Adult Stem Cell Patient and Physicians Discuss Clinical Trial | SYS-CON INDIA

I’M SORRY…AM I MISSING SOMETHING?

“WORLD’S FIRST?”

WHAT ABOUT THE HUNDREDS, IF NOT THOUSANDS OF CARDIAC ADULT STEM CELL PATIENT THAT HAVE BEEN TREATED ALL OVER THE WORLD?

WHEN IS THE US GOING TO WAKE UP TO THE FACT THAT THEY ARE YEARS BEHIND IN STEM CELL TREATMENTS?

-dg

World’s First Cardiac Adult Stem Cell Patient and Physicians Discuss Clinical Trial

By: PR Newswire

Jul. 23, 2009 09:06 AM

Infusion Procedure Performed on July 17th

LOUISVILLE, Ky., July 23 /PRNewswire-USNewswire/ — University of Louisville physicians performed the world’s first cardiac adult stem cell infusion procedure at Jewish Hospital in Louisville, KY, on July 17, 2009. The procedure is part of the first FDA-approved clinical trial using adult cardiac stem cells to treat heart disease.

via World’s First Cardiac Adult Stem Cell Patient and Physicians Discuss Clinical Trial | SYS-CON INDIA.

Mice pups bred from adult stem cells – ABC News Australian Broadcasting Corporation

Mice pups bred from adult stem cells

By David Mark for AMAM | abc.net.au/am

Posted Fri Jul 24, 2009 11:00am AEST

The oldest mice are nine months old and while some are showing abnormalities, they are reproducing.

For the first time, researchers have created mouse pups using adult stem cells.The work of two separate teams, both from China, is described in two papers published today in the journals Nature and Cell Stem Cell.

The breakthrough was made using re-programmed adult stem cells which, like embryonic stem cells, can be turned into any cell in the body.

Dr Andrew Laslett, the group leader of Human Embryonic Stem Cell Technology at the Australian Stem Cell Centre in Melbourne, says it is the first time “induced pluripotent stem cells” IPS cells have been used to make an entire mouse.

Put simply, IPS cells are adult stem cells, in this case taken from the tail or skin of a mouse.The researchers have introduced genes into the cells to reprogram them to become the equivalent of an embryonic stem cell.

Students embed stem cells in sutures to enhance healing

Students embed stem cells in sutures to enhance healing

IMAGE: Surgical thread can be embedded with a patient’s own adult stem cells to promote healing.

Click here for more information.

Johns Hopkins biomedical engineering students have demonstrated a practical way to embed a patient’s own adult stem cells in the surgical thread that doctors use to repair serious orthopedic injuries such as ruptured tendons. The goal, the students said, is to enhance healing and reduce the likelihood of re-injury without changing the surgical procedure itself.

The project team — 10 undergraduates sponsored by Bioactive Surgical Inc., a Maryland medical technology company — won first place in the recent Design Day 2009 competition conducted by the university’s Department of Biomedical Engineering. In collaboration with orthopedic physicians, the students have begun testing the stem cell–bearing sutures in an animal model, paving the way for possible human trials within about five years.

The students believe this technology has great promise for the treatment of debilitating tendon, ligament and muscle injuries, often sports-related, that affect thousands of young and middle-aged adults annually. “Using sutures that carry stems cells to the injury site would not change the way surgeons repair the injury,” said Matt Rubashkin, the student team leader, “but we believe the stem cells will significantly speed up and improve the healing process. And because the stem cells will come from the patient, there should be no rejection problems.”

via Students embed stem cells in sutures to enhance healing.

Brigham and Women’s opens cord-blood bank – The Boston Globe

Boston gets first public cord-blood bank

Donations treat deadly diseases

By Tara Ballenger

Globe Correspondent / July 20, 2009

Some 8,000 mothers who give birth at Brigham and Women’s Hospital each year can now donate blood from their umbilical cords to a public bank where it may be a match for someone facing a life-threatening disease.

Public banks, which store cord blood for the stem cells that can combat leukemia, lymphoma, and other deadly illnesses, have existed for two decades, yet they have been eclipsed in recent years by private banks that urge mothers to pay an annual fee to bank the cord blood, in case their child or a relative needs it one day.

The Brigham and Women’s donation center, which opened in late May, is the first in Boston and has so far collected 130 cord-blood donations. Two other hospitals in New England allow mothers to donate cord blood – UMass Memorial Medical Center in Worcester and Women & Infants Hospital in Providence.

Demand for the opportunity to donate cord blood was strong among Boston women, said Dr. Robert Barbieri, chairman of obstetrics and gynecology at Brigham and Women’s and co-coordinator of the program. Barbieri said he received several calls each month from women asking where they could donate.

“It’s a great way to use a biological resource to give people hope for the future,’’ said Barbieri. “It’s a gift of life.’’

via Brigham and Women’s opens cord-blood bank – The Boston Globe.

Retired Perth Amboy principal ‘reborn’ after stem-cell transplant | mycentraljersey.com | MyCentralJersey.com

Northwestern Memorial Hospital in Chicago

Retired Perth Amboy principal ‘reborn’ after stem-cell transplantBy SUZZANE C. RUSSELL • STAFF WRITER • July 19, 2009

PERTH AMBOY — Michael George feels so good he can pinch himself.AdvertisementAnd today, after undergoing an autologous adult stem-cell transplant 14 months ago to stop his advanced case of scleroderma, an incurable autoimmune disease that causes excess collagen to make skin tighten and feel hard and thick, George is able to pinch his pliable skin. He’s also able to open his mouth real wide.

“I feel really good,” said George, a retired William C. McGinnis School principal, who in April was taken off all medications, including antibiotics, related to his transplant.

“I feel I was reborn,” George said. “It’s great to be alive.”

It was at his one-year check-up in April doctors told George, an avid fisherman, that he can now do anything he wants.

He recently returned from a five-day trip to Martha’s Vineyard, where he went fishing with friends. And soon George will travel to Spain with his wife, Alice, brother and sister and their families during which he will celebrate his 40th wedding anniversary.

“We’re looking forward to it,” he said.

And he’s spending lots of time this summer on his 22-foot fishing boat, which he affectionately refers to as “my baby” and along the city’s marina.

“This is my passion,” said George while sitting along the marina. “This is my kind of weather.”

Just before the March 13, 2008, adult stem-cell transplant, George’s skin was stiff and his face was tight. He had a hard time swallowing. Doctors were concerned his condition was spreading internally to the point it might close his esophagus and damage his heart and lungs.

The procedure George underwent at Northwestern Memorial Hospital in Chicago involved taking stem cells from his bone marrow, cleaning and freezing them while he received large doses of chemotherapy to cleanse his immune system before the stem cells were put back into his body to grow.

via http://www.mycentraljersey.com/article/20090719/NEWS/90719004/-1/newsfront/Retired+Perth+Amboy+principal++reborn++after+stem-cell+transplant