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Jeannine
08-30-2010, 10:54 AM
Note: I believe this treatment should be available for those with COPD as well. Many more COPD patients die from heart failure than from the COPD.

Improves Function of Heart
Bone Marrow Stem Cells Treat Heart Failure

A study in Germany showed that chronic heart failure patients injected with of their own bone marrow stem cells lived longer and had improved heart function. One hundred and ninety one patients were given the treatment and 200 were not. The benefits were observed after three months of injections and lasted for 5 years. Over the five-year period during the study, only seven patients in the treatment group died compared to 32 in the control group. Doctors have been using many different forms of stem cells to treat heart damage. Unlike drugs which do not treat the loss of tissue function, lead researcher Strauer pointed out that ?this therapy can improve quality of life, increase ventricular performance and increase survival" in place of or in addition to conventional treatments.

barbara
08-31-2010, 01:52 PM
German scientists have posted some of the most convincing long-term data yet seen demonstrating that injections of a chronic heart failure patient's own bone marrow stem cells can significantly improve heart function and raise their chances of survival.

The researchers recruited close to 400 subjects for the trial, nearly evenly dividing them between a group that received stem cell injections and another group which opted to go without the added therapy. Researchers said they could begin tracking a positive response after three months and found that after five years only seven of the stem cell treatment group had died compared to 32 in the control arm of the study. All of the patients were provided standard therapy for their condition.

"Our study suggests that, when administered as an alternative or in addition to conventional therapy, bone marrow cell therapy can improve quality of life, increase ventricular performance and increase survival," said lead researcher Bodo-Eckehard Strauer of Duesseldorf's Heinrich Heine University. And Strauer went on to tell a gathering in Stockholm that the therapy presents no risks and "can only be beneficial."

Not everyone who has reviewed the data, though, is so certain. "God gave us two gifts for doing clinical research--blinding and randomization," Rob Califf, vice chancellor for research at Duke University, told MedPage Today. "If you have done neither, your data are interesting but not definitive."

barbara
08-31-2010, 01:55 PM
If this has no risk, then patients should be able to opt for it if they want. It's unethical to withhold treatment in my opinion.

ESC: Bone Marrow Cells May Help Heal Hearts

By Todd Neale, Staff Writer, MedPage Today
Published: August 29, 2010
Reviewed by Adam J. Carinci, MD; Instructor, Harvard Medical School and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner



Note that the study was nonblinded and nonrandomized, thus making definitive conclusions difficult.

STOCKHOLM -- Injecting autologous bone marrow stem cells directly into the hearts of patients with chronic heart failure appears to improve ventricular performance, quality of life, and survival, according to an open-label, nonrandomized study.
Benefits of the stem cell treatment were apparent within three months -- and persisted for up to five years of follow-up, Bodo-Eckehard Strauer, of Heinrich Heine University of D?sseldorf, Germany, reported at the European Society of Cardiology Congress here.

Patients who did not receive a stem cell infusion and remained on optimal medical therapy continued to deteriorate throughout the follow-up period.

There were no side effects, Strauer said in a "Hot Line" session.

The findings were reported earlier this year in the European Journal of Heart Failure -- a journal of the ESC -- which led the society to bar Strauer from submitting abstracts for two years. Presenting previously-published data broke the rules for "Hot Line" data.

Strauer said at a press briefing that patients with more severe heart failure seem to fare better from the stem cell treatment.

"This therapy has almost no risk. It can only be beneficial in patients. So, in my opinion, it has real clinical importance for the treatment of heart failure," he said.

Rob Califf, MD, vice chancellor for research at Duke University, highlighted the limitations of the study in his comments to MedPage Today:

"God gave us two gifts for doing clinical research -- blinding and randomization," Califf said in an interview. "If you have done neither, your data are interesting but not definitive."

Strauer and his colleagues initially approached 391 patients with chronic heart failure resulting from an acute MI to participate in the study -- 191 agreed to receive an autologous bone marrow stem cell infusion, and 200 declined but agreed to participate as controls. The average period since patients experienced an MI was 8.5 years.

Although not randomized, the two groups had similar characteristics at baseline.

Mean left ventricular ejection fraction was 29.5% in the treatment group and 36.1% in the control group, but the difference was not statistically significant.

All patients continued to receive optimal medical therapy.

For the bone marrow cell infusion, the researchers harvested stem cells from the patients' iliac crest. Mononuclear cells were isolated and rinsed with heparinized saline.

An average of 66 million stem cells per patient were infused into the infarct-related artery via an angioplasty balloon catheter. Inflation of the balloon simulated an ischemic condition, which prevented back-flow of the cells and provided time for cell migration to the infarct area.

At the three-month follow-up, there was significant improvement in left ventricular performance in the treatment group, reflected by improved cardiac index (by 22%), peak oxygen uptake (by 11%), and oxygen pulse (by 6.3%) (P<0.05 for all).

Exercise capacity increased by 15.4% from baseline, and left ventricular ejection fraction improved from 29.4% at baseline to 36% at three months (P<0.01 for both).

Both end-diastolic and end-systolic volume decreased from baseline in the treatment group (P<0.05 for both).

There were gains in quality of life as well, with the mean New York Heart Association (NYHA) class dropping from 3.22 to 2.25 (P<0.0167). In the control group, NYHA worsened from 3.06 to 3.5.

The benefits in the treatment group persisted through one and five years.

The control group continued to deteriorate through the follow-up points.

Survival was better in the treatment group than in the control group. Through follow-up, 0.75% of the stem cell-treated patients died each year compared with 3.68% per year among controls (P<0.01).

"The reason [for the mortality reduction] may be twofold; namely, a decrease in pump failure and a decrease in severe cardiac arrhythmias," Strauer and his colleagues wrote in their paper.

Commenting after Strauer's presentation at the meeting, Francisco Fernandez-Aviles, MD, PhD, of the Hospital General Universitario Gregorio Mara??n in Madrid, noted the study's limitations stemming from the open-label nonrandomized design.

"But it is the largest trial comparing bone marrow cells versus optimal conventional therapy in patients with heart failure due to healed myocardial infarction," added Fernandez-Aviles, who highlighted many of the positive findings from the study.

He said that certain steps should be taken before conducting large-scale clinical trials of the stem cell treatment.

"Translational, randomized, double-blinded, mechanistic studies are necessary to confirm these results, to further elucidate mechanisms, to identify the subgroups of patients with the highest benefit, and to compare different cells and different methods of delivery," Fernandez-Aviles said.

Strauer reported that he had no conflicts of interest.

Califf disclosed that in his position he oversees research funded by most pharmaceutical companies.


Primary source: European Society of Cardiology
Source reference:
Strauer B-E "The STAR Heart Study: the acute and long-term effect of intracoronary stem cell transplantation in 191 patients with chronic heart failure" ESC 2010; Abstract 381.

jgp
09-05-2010, 01:25 PM
i go to cleveland clinic for pulmonary, standard stuff, inhalers, tests. oxygen. but since they are no 1 for heart they have lots of stem cell trials going on if interested https://my.clevelandclinic.org/heart/disorders/heartfailure/stemcells.aspx they give you all the info you need. i just wish they were no#1 for lungs.