New human trial shows stem cells are effective for failing hearts

PUBLIC RELEASE DATE:

31-Mar-2014

Contact: Beth Casteel bcasteel@acc.org 202-375-6275 American College of Cardiology

WASHINGTON (March 31, 2014) Patients with severe ischemic heart disease and heart failure can benefit from a new treatment in which stem cells found in bone marrow are injected directly into the heart muscle, according to research presented at the American College of Cardiology's 63rd Annual Scientific Session.

"Our results show that this stem cell treatment is safe and it improves heart function when compared to placebo," said Anders Bruun Mathiasen, M.D., research fellow in the Cardiac Catherization Lab at Rigshospitalet University Hospital Copenhagen, and lead investigator of the study. "This represents an exciting development that has the potential to benefit many people who suffer from this common and deadly disease."

Ischemic heart disease, also known as coronary artery disease, is the number one cause of death for both men and women in the United States. It results from a gradual buildup of plaque in the heart's coronary arteries and can lead to chest pain, heart attack and heart failure.

The study is the largest placebo-controlled double-blind randomized trial to treat patients with chronic ischemic heart failure by injecting a type of stem cell known as mesenchymal stromal cells directly into the heart muscle.

Six months after treatment, patients who received stem cell injections had improved heart pump function compared to patients receiving a placebo. Treated patients showed an 8.2-milliliter decrease in the study's primary endpoint, end systolic volume, which indicates the lowest volume of blood in the heart during the pumping cycle and is a key measure of the heart's ability to pump effectively. The placebo group showed an increase of 6 milliliters in end systolic volume.

The study included 59 patients with chronic ischemic heart disease and severe heart failure. Each patient first underwent a procedure to extract a small amount of bone marrow. Researchers then isolated from the marrow a small number of mesenchymal stromal cells and induced the cells to self-replicate. Patients then received an injection of either saline placebo or their own cultured mesenchymal stromal cells into the heart muscle through a catheter inserted in the groin.

"Isolating and culturing the stem cells is a relatively straightforward process, and the procedure to inject the stem cells into the heart requires only local anesthesia, so it appears to be all-in-all a promising treatment for patients who have no other options," Mathiasen said.

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New human trial shows stem cells are effective for failing hearts

New human trial shows stem cells are effective for failing hearts: Bone marrow-derived stem cells injected directly …

Patients with severe ischemic heart disease and heart failure can benefit from a new treatment in which stem cells found in bone marrow are injected directly into the heart muscle, according to research presented at the American College of Cardiology's 63rd Annual Scientific Session.

"Our results show that this stem cell treatment is safe and it improves heart function when compared to placebo," said Anders Bruun Mathiasen, M.D., research fellow in the Cardiac Catherization Lab at Rigshospitalet University Hospital Copenhagen, and lead investigator of the study. "This represents an exciting development that has the potential to benefit many people who suffer from this common and deadly disease."

Ischemic heart disease, also known as coronary artery disease, is the number one cause of death for both men and women in the United States. It results from a gradual buildup of plaque in the heart's coronary arteries and can lead to chest pain, heart attack and heart failure.

The study is the largest placebo-controlled double-blind randomized trial to treat patients with chronic ischemic heart failure by injecting a type of stem cell known as mesenchymal stromal cells directly into the heart muscle.

Six months after treatment, patients who received stem cell injections had improved heart pump function compared to patients receiving a placebo. Treated patients showed an 8.2-milliliter decrease in the study's primary endpoint, end systolic volume, which indicates the lowest volume of blood in the heart during the pumping cycle and is a key measure of the heart's ability to pump effectively. The placebo group showed an increase of 6 milliliters in end systolic volume.

The study included 59 patients with chronic ischemic heart disease and severe heart failure. Each patient first underwent a procedure to extract a small amount of bone marrow. Researchers then isolated from the marrow a small number of mesenchymal stromal cells and induced the cells to self-replicate. Patients then received an injection of either saline placebo or their own cultured mesenchymal stromal cells into the heart muscle through a catheter inserted in the groin.

"Isolating and culturing the stem cells is a relatively straightforward process, and the procedure to inject the stem cells into the heart requires only local anesthesia, so it appears to be all-in-all a promising treatment for patients who have no other options," Mathiasen said.

Although there are other therapies available for patients with ischemic heart disease, these therapies do not help all patients and many patients continue to face fatigue, shortness of breath and accumulation of fluid in the lungs and legs.

Previous studies have shown mesenchymal stromal cells can stimulate repair and regeneration in a variety of tissues, including heart muscle. Mathiasen said in the case of ischemic heart failure, the treatment likely works by facilitating the growth of new blood vessels and new heart muscle.

The study also supports findings from previous, smaller studies, which showed reduced scar tissue in the hearts of patients who received the stem cell treatment, offering additional confirmation that the treatment stimulates the growth of new heart muscle cells.

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New human trial shows stem cells are effective for failing hearts: Bone marrow-derived stem cells injected directly ...

'Fabricated' stem cell paper may have just been proven valid

Just weeks after invalidating a groundbreaking paper describing a simple technique for generating pluripotent stem cells, professor Kenneth Ka Ho Lee now believes he has identified the correct approach.

Lee, chief of stem cell research at the Chinese University of Hong, spoke to Wired.co.uk in March about his tentative excitement when he read the Nature study in question, published at the start of the year. The proposed Stap cells (stimulus-triggered acquisition of pluripotency) in it were a revelation, because they suggested there was a simple way to generate embryonic-like stem cells that could potentially be used in the treatment of diseases such as Parkinson's. The method involved reprogramming a donor's own adult blood and skin cells (in this case, mice) by exposing them to extreme trauma, such as an acid bath.

Lee could see its potential, but like the rest of the community he had his doubts. While reports circulated that the images published in the Nature study also featured in older papers penned by lead researcher Haruko Obokata of Japan's Riken Centre, Lee set about trying to replicate the experiment himself.

It didn't work.

Since then the Riken Centre has launched an investigation into the legitimacy of the trial, and that investigation today revealed Obokata had indeed falsified information, including results and images of DNA fragments used.

"Actions like this completely destroy data credibility," commented Shunsuke Ishii, head of the investigative committee and a Riken molecular geneticist, at a press conference. "There is no doubt that she was fully aware of this danger. We've therefore concluded this was an act of research misconduct involving fabrication." Obokata has denied the allegations, but Riken says its own research team will be the one to verify the results and carry out the experiment again.

In the interim however, a coauthor on the paper at the centre of the debacle,Charles Vacanti published yet another protocol for the Stap technique. Vacanti, of ear-on-a-mouse fame, is a professor at Harvard Medical School and published online what he said was found to be "an effective protocol for generating Stap cells in our lab, regardless of the cell type being studied". It was a combination of the two approaches mentioned in the Naturepaper -- the acid bath, and the trituration process (the application of pressure on the cells using pipettes to induce stress). He describes the latter process as being exerted with force, more so than in the original paper, and over a lengthy period -- twice a day for the first week.

Nature had already rejected Lee's version of experiments for publication last month. Undeterred, he set about applying Vacanti's technique. Liveblogging the experiments on ResearchGate, the open source platform where Lee had published his first set of experiments, the Hong Kong researcher immediately saw the excess stress was leading to rapid cell death among the lung fibroblast cells used.

"We estimated that there was a 50 percent decrease in cell number," Lee wrote four days ago on the blog. "In the original paper reported in Nature, such decrease in cell count was reported for day two, which is inline with our current experiment. Day three will be critical as this was the time Oct4-GFP expression [an indication that stem cells are generating] was reported for Stap cells. If we find that the cell number decreased even more drastically in our cultures, we will harvest some of the cultures and use them directly for qPCR analysis [quantitative polymerase chain reaction,a screening technique for stem cells]."

Nevertheless, things appeared to turn around. In his preliminary studies Lee has concluded that it could be the extreme stress through trituration, and not the acid bath, that was responsible for creating the Stap cells. "I am shocked and amazed by the qPCR results for the three-day-old control and Stap cultures," he wrote on ResearchGate, alongside a graph of the results. "Totally speechless!"

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'Fabricated' stem cell paper may have just been proven valid

Stem-cell treatment may help those with severe vision problems

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Paul Walker will undergo an eye procedure next week that could give him back simple pleasures such as working in the garden or leafing through a magazine.

The procedure, an experimental stem-cell treatment, has already restored some sight for two other central Ohioans and holds the same hope for Walker, a Bexley resident who is legally blind.

Are you kidding? was Walkers initial reaction when Susan Benes, a Columbus neuro-ophthalmologist, told him a few months ago that a clinical trial offered the promise of better vision.

The Stem Cell Ophthalmology Treatment Study is a federally approved trial being conducted at Retinal Associates, a medical practice near Fort Lauderdale, Fla. The study tests stem-cell treatment on people 18 and older with glaucoma, macular degeneration and various retinal disorders.

The trial, which began in August and is scheduled to run until 2017, can offer only anecdotal evidence of effectiveness at this point, said study director Steven Levy, a Connecticut doctor who is president of the consulting company MD Stem Cells.

Still, results have been encouraging in the 35 or so people treated to date.

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Stem-cell treatment may help those with severe vision problems

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