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]

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