Mobilisation of Hematopoietic CD34+ Precursor Cells in Patients with Acute Stroke Is Safe - Results of an Open-Labeled Non Randomized Phase I/II Trial
2011

Safety of G-CSF Treatment in Acute Stroke Patients

Sample size: 20 publication 10 minutes Evidence: moderate

Author Information

Author(s): Boy Sandra, Sauerbruch Sophie, Kraemer Mathias, Schormann Thorsten, Schlachetzki Felix, Schuierer Gerhard, Luerding Ralph, Hennemann Burkhard, Orso Evelyn, Dabringhaus Andreas, Winkler Jürgen, Bogdahn Ulrich

Primary Institution: Department of Neurology, University of Regensburg, Bezirksklinikum Regensburg, Regensburg, Germany

Hypothesis

Can G-CSF treatment safely mobilize CD34+ stem cells in patients with acute ischemic stroke?

Conclusion

The study demonstrates a good safety profile for G-CSF treatment in acute stroke patients, with some positive functional effects observed.

Supporting Evidence

  • G-CSF treatment was started within 12 hours of stroke onset.
  • Mobilization of CD34+ cells was observed without significant adverse effects.
  • Neuropsychological tests showed improvements in some cognitive functions.

Takeaway

This study tested a medicine called G-CSF to see if it could help people who had a stroke. It was found to be safe and might help some people feel better.

Methodology

Patients were treated with G-CSF in a dose-escalation design and monitored for safety and changes in CD34+ cell counts.

Potential Biases

Potential bias due to the open-label design and lack of a control group.

Limitations

The study had a small sample size and was open-label, which may affect the generalizability of the results.

Participant Demographics

20 patients, mean age 55 years, 13 male and 7 female.

Statistical Information

P-Value

p<0.05

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1371/journal.pone.0023099

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