Abstract 383: First Documentation of Human Intra-Arterial Delivery of Autologous Bone Marrow Mononuclear Cells with Transcranial Doppler Monitoring During Transplantation In Acute Ischemic Stroke: A Safety Study
Background: TCD and EEG abnormalities during carotid and heart surgery have been previously associated with worse outcome following these procedures. Purpose:This phase I open label trial was designed to assess the feasibility and safety of autologous bone marrow mononuclear cells (ABMMC) in acute ischemic stroke patients. To assess the safety of intra cerebral arterial delivery of ABMMC transplantation we monitored the procedure with transcranial doppler. EEG was realized during the procedure, as well as, during the first 48 hours after the procedure.
Methods: 6 patients and 3 controls with an ischemic stroke including the territory of the middle cerebral artery (MCA) with spontaneous recanalization confirmed by Magnetic Resonance Angiography, and with a NIHSS score between 4 and 20. Between the third and tenth day after stroke onset, bone marrow cells were aspirated from the posterior iliac crest. On the same day, 30 million ABMMC were injected in the MCA via catheter angiography. Brain perfusion with 99mTc-ECD SPECT; PWI/DWI-MRI and brain PET-FDG were performed at baseline and after 7 days, 3 and 6 months of ABMMC injection.
Results: We report the results of the first 6 treated patients (4 males, age 49.8±7.8 ). No EEG abnormalities were detected during ABMMC injection. There was no flow disturbance in these pts. In 4 patients we could detect a mean of 128±89 microembolic signals (MES) during ABMMC injection. In one patient a high number of MES (228) was detected. With the last 2 pts, we worked with greater time of homogenization and warming (from 30 sec to 2 min). With this technique we did not find any MES record. Clinical and neuroimaging assessments at follow-up did not show any new deleterious abnormality compared to baseline.
Conclusions: This first documentation of human intravascular delivery of ABMMC showed no flow abnormalities, as well as, suggest an improvement in delivery technique. There was no adverse effect recorded in these stroke pioneers cases. The absence of MES suggest no correlation with potential adverse effeects observed in carotid and heart surgery.