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The present study was conducted in patients with Parkinson's disease (PD) with the objective to evaluate the safety (primary end point) and potential efficacy (secondary end point) of intra-arterial administrations of Autologous Unfractionated Bone Marrow (AUBM) cells.
To achieve this, we conducted a clinical trial in 10 PD patients diagnosed per an experienced neurologist. A target volume of 120 ml of AUBM was infused intra-arterially into internal carotid and vertebral arteries. Safety analysis procedure related and follow up were evaluated. Neurological evaluation at baseline,1, 3, 6 and 12 months follow-up were evaluated by Hoehn and Yahr scale (H & Y), Unified Parkinson's Disease Rating Scale (UPDRS) and Schwab and England scale (S&E). Neuroimaging study either with perfusion Computed Tomography (CT) or Brain Perfusion Spect 99m Tc (PS) were conducted at baseline, 1 and 12 months follow-up. Cerebral Digital Subtraction Angiography (DSA) was performed.
Mean age 68 ± 9 years, male 70%, with a mean duration of onset of the disease 9 ± 4 years. There were no procedure-related adverse events and during follow-up of 12 ± 4 months. Significant neurological improvement was observed in the mean follow-up score in H&Y from 3.7 ± 0.82 to 2.25 ± 0.82 (p< 0,001), in UPDRS from 64 ± 32 to 38 ± 32 (p< 0,004) and in S&E from 52% ± 17% to 73% ± 14% (p< 0,001). Perfusion CT performed in 4 patients showed improvements in perfusion with mean baseline peak arterial enhancement of 122 ± 47 pixels to 204 ± 32 pixels in the follow up. Brain PS conducted in 6 patients showed areas of hypoperfusion in 4 patients with significant improvements in follow-up, in 2 patients were normal and unchanged in the follow up. Improvements in clinical score and neuroimaging study were observed in 8 of 10 patients (80%). The 2 patients who did not improve had normal PS study. The cerebral DSA images were evaluated by an independent neuroradiology laboratory with the following findings: bovine aortic arch in 8 patients (80%), fetal origin of the posterior cerebral artery in 4 patients (40%), hypoplasia A1 of anterior cerebral artery in 5 patients (50%).
Present study gives evidence that PD patients the intra-arterial route for delivery of cells such as AUBM is safe. A correlation between the clinical Improvements and cerebral perfusion was found. The number of patients recruited and the uncontrolled nature of the study did not permit demonstration of effectiveness of the treatment involved. However, the results encourage future studies with more patients to demonstrate efficacy.
- 2013 American College of Cardiology Foundation