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Pivotal heart disease stem cell trial launched

05 March 2012

By Cathy Holding

Appeared in BioNews 647

A major clinical trial to investigate a stem cell treatment for chronic ischemic heart disease (IHD) – a leading cause of death around the world – has begun in the US.

The treatment – developed by the life sciences company Baxter – uses patients' own stem cells to repair damage to the heart. IHD is a condition where the blood supply to the heart is reduced, usually due to narrowing or blockage of the arteries that supply the heart with blood.

Were this phase III trial to be successful it would represent the last step in the clinical development process before submission by the regulatory authorities and, hopefully, approval and commercialisation. Unlike some of the other recent stem cell trials to repair heart damage (reported in BioNews 645, 634 and 624) this procedure uses stem cells from a patient's bone marrow that are normally involved in the creation of new blood vessels.

In the procedure these CD34+ cells are stimulated to grow and multiply, before being induced to enter the bloodstream. The cells are then collected, processed and injected into targeted areas of the heart.

Around 450 patients will be enrolled in the trial and split into three treatment groups: one group who will receive the therapy, one group who will receive placebo and a third group who will receive standard medical care. Ability to exercise one year after therapy will be a key indicator of the treatment's effectiveness. Doctors will also collect safety data for two years following the start of the therapy.

The current trial follows on from a phase II study, where the CD34+ stem cell treatment improved exercise capacity and reduced chest pain. 'This is the first time these endpoints have been achieved in a population of patients who have exhausted conventional treatment options', said Dr Douglas Losordo, vice president of new therapeutic development at Baxter.

Baxter (press release) | 28 February 2012
Mass Device | 28 February 2012


18 February 2013 - by Reuben Harwood 
What would be the first clinical trial to use induced pluripotent stem cells has been granted ethical approval in Japan...
12 November 2012 - by Dr Nicola Davis 
Stem cells obtained from donors have been used in clinical trials to effectively treat damage caused by heart attacks. The trial found that donor stem cells were 'just as safe' as stem cells derived from the person being treated....
12 November 2012 - by Dr Anna Cauldwell 
Eight heart attack patients given injections of stem cells harvested from their own hearts show significant improvement in their heart function two years after treatment...
16 July 2012 - by Dr Greg Ball 
Two UK newspapers have hailed a potential treatment for osteoarthritis using a patient's own stem cells although results from early studies in animals and patients are yet to be published...
11 June 2012 - by Dr Rebecca Hill 
A previously unidentified type of stem cell, usually dormant in blood vessels, is at the heart of vascular disease, according to researchers...

20 February 2012 - by Cathy Holding 
A stem cell-based therapy aiming to reverse the damage caused by heart attacks has shown positive results in an early clinical trial...
21 November 2011 - by Victoria Kay 
The world's first clinical trial using patients' own cardiac stem cells to repair heart damage has produced surprising results. The preliminary trial was designed simply to test the safety of the procedure, but doctors observed an unexpected improvement in heart function in patients receiving the treatment...
12 September 2011 - by Rosie Beauchamp 
An Australian company has announced it has received regulatory approval from the European Medicines Agency (EMA) to begin phase II trials for its cardiovascular stem cell treatment, Revascor....
18 July 2011 - by Dr Sarah Spain 
Researchers at Northwestern University, Chicago, USA, have reported that the injection of stem cells into heart tissue can significantly improve the symptoms of those with severe angina. They found that exercise tolerance was increased and the number of pain episodes was halved, compared to those not given the injections....

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