Abstract 100: Cellular Therapy for Acute Stroke: Assessing a Potential Treatment Effect
Introduction Cell therapy is an investigational modality to enhance recovery after stroke. We completed a Phase I clinical trial of 25 patients assessing the safety and feasibility of autologous bone marrow derived mononuclear cells (MNCs). Study participants underwent a bone marrow harvest and were intravenously administered autologous MNCs 24-72 hours after stroke onset. We report an ordinal analysis that compares 90-day outcomes of study patients with retrospectively generated controls.
Methods We compared the study patients to a group of patients derived from our stroke registry who presented to our center during the same time period as the clinical trial. The control group was initially matched for age and NIHSS and was further refined based on other inclusion / exclusion criteria of the trial, generating a final set of 185 patients. Between the two groups, we compared demographics, clinical characteristics, baseline lab values, co-morbidities and adverse events. An ordinal logistic regression model, utilizing the full range of outcome scores, was fitted to compare 90-day mRS scores.
Results: The bone marrow harvest and infusion of MNCs was completed successfully in all study patients without any definitive study related severe adverse event. Table 1 shows the balance of tested co-variates between the stem cell and control groups. After controlling for 24-48 hour NIHSS, t-PA, rehab, length of stay, cardiac disease, and PTT, the final model estimated a greater odds of having a higher mRS at 90 days in the control group compared with the study patients (OR: 3.25, 95% CI: 1.48 - 7.14). Our model did not violate the proportionality of odds assumption (likelihood-ratio, p=0.1). Figure 1 shows the proportion of patients for each level of discharge and day 90 mRS score.
Conclusion: Intravenous infusion of autologous MNCs is safe in the setting of acute stroke. This analysis suggests that patients receiving MNCs may also be exhibiting a signal of enhanced functional recovery.
- © 2012 by American Heart Association, Inc.