IV stem cell therapy safe for stroke patients

Issue: April 2012

International Stroke Conference 2012

NEW ORLEANS — Intravenous stem cell therapy was safe and feasible in patients with stroke and may aid in functional recovery after stroke, according to two studies presented at the American Stroke Association’s International Stroke Conference.

Kameshwar Prasad, MD, of All India Institute of Medical Sciences, New Delhi, and colleagues studied 120 stroke patients aged 18 to 75 years for the InVeST trial. Half were treated with stem cells taken from bone marrow in the iliac crest, then harvested and infused into a vein; the other half served as a control group. Participants were observed for adverse reactions after infusion and tumor formation for up to 1 year. Seventy-nine patients underwent whole-body PET at the end of 1 year.

Results showed that 71% of the stem cell group achieved assisted independence (Barthel Index ≥60) at 6 months compared with 63% of the control group (P=.17). Trends were similar for modified Rankin Scale and NIH Stroke Scale, but did not reach statistical significance. IV injection of bone marrow mononuclear cells was associated with a statistically nonsignificant increase in the proportion of dependence-free survival of 8%, the researchers concluded in their poster presentation.

In addition, IV bone marrow mononuclear cell therapy was not associated with any increase in adverse events (30 in the stem cell group vs. 35 in the control group). Death was reported in eight patients in the stem cell group vs. five in the control group. No patient developed evidence of tumor based on PET scan at 1 year.

“There is a trend of better outcome if the number of bone marrow mononuclear cells injected is more than 300 million in the second week, rather than later, but this did not reach statistical significance,” the researchers concluded.

In the second study, Rohit Bhatia, MD, Ashu Bhasin, PhD, and colleagues also found that stem cell therapy used as regenerative therapy in stroke patients appeared to be safe, with no signs of clinical, laboratory or radiologically detected adverse events.

The case-control study evaluated the safety, feasibility and efficacy of autologous mononuclear and mesenchymal stem cell therapy in stroke patients evaluated on clinical scores and functional imaging. Of 40 patients studied, 14 were administered mononuclear stem cells and six received cultured expanded mesenchymal stem cells (50 million to 60 million cells dissolved in 250 mL saline and infused intravenously over 2 to 3 hours); the other 20 patients served as controls.

The stem cell group experienced significant improvement in daily living activities such as feeding, dressing and mobility, using the modified Barthel Index (P=.05), as compared with controls. There was also an increase in brain activity in areas of the brain responsible for movement planning and motor function.

Clinical, laboratory and radiological tests were normal for the stem cell group. There was no mortality or therapy-related adverse events.

The researchers, also from All India Institute of Medical Sciences, conducted the study because the “alarming disability burden and a high prevalence rate of stroke in India has encouraged the researchers to develop new therapies to reduce clinical deficits.” They said, “stem cells act as ‘scaffolds’/cellular mediators for neural transplantation and may aid in repair mechanisms in stroke.” – by Katie Kalvaitis

For more information:

Bhatia R. Abstract #3369.
Prasad K. Abstract #3337. Both presented at: the American Stroke Association’s International Stroke Conference 2012; Feb. 1-3, 2012; New Orleans.

Disclosure: Drs. Bhatia and Prasad report no relevant financial disclosures.

Douglas W. Losordo, MD
Douglas W. Losordo

In the field of CV medicine today there has been growing interest in the use of stem cells for treatment of a variety of conditions. In 2012 there are a number of investigations that are either underway or are being planned to evaluate various stem cell therapies in patients with acute or chronic cardiac disease. I have been working on cell-based therapies in CVDs for most of my adult life, and it is interesting to see that this work is starting to have an impact. It is my opinion that there will be available, proven therapies for patients with cardiac disease, not this year or next year, but within the foreseeable future.

My interest in this field started back in the late 1990s when Takayuki Asahara, a postdoctoral fellow working in the Jeff Isner’s lab made the observation that adult mammals have circulating stem cells that were capable of repairing damaged ischemic tissue, like an MI or stroke. That observation changed, virtually overnight, what we were doing in the lab because it was our sense that this novel approach would change the way we looked at diseases like MI and stroke. We had previously thought of these as permanent injuries; the data we started to generate, indicating that our bodies own supply of stem cells could reverse ischemic damage, led us to start to fantasize, frankly, that maybe these weren’t permanent injuries, and that we could take advantage of the body’s natural repair mechanisms to reverse some of the damage that occurs with a MI or stroke.

For these two studies, investigators took a patient’s own cells from the bone marrow, which is where a lot of stem cells live, presumably did something to purify them and then re-infused the cells into the patients. They were able to show some nice trends toward improvement in function in these patients. These are small studies, as they should be in a first-in-man experiment; however, the trends are notable. The fascinating part to me is that there was no drug therapy involved; the investigators simply took a cell that the body has already preprogrammed and concentrated a dose of those cells in the region of the damage. These data are an indication of the fact that the field is moving along.

– Douglas W. Losordo, MD
Cardiology Today Editorial Board member

Disclosure: Dr. Losordo is an employee of Baxter.

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