Autologous intravenous bone marrow mononuclear cell therapy for patients with subacute ischaemic stroke: a pilot study.

Background & objectives: Bone marrow mononuclear cell therapy has emerged as one of the option for the treatment of Stroke. Several preclinical studies have shown that the treatment with mononuclear cell (MNCs) can reduce the infarct size and improve the functional outcome. We evaluated the feasibility, safety and clinical outcome of administering bone marrow mononuclear cell (MNCs) intravenously to patients with subacute ischaemic stroke. Methods: In a non-randomized phase-I clinical study, 11 consecutive, eligible and consenting patients, aged 30-70 yr with ischaemic stroke involving anterior circulation within 7 to 30 days of onset of stroke were included. Bone marrow was aspirated from iliac crest and the harvested mononuclear cells were infused into antecubital vein. Outcomes measured for safety included immediate reactions after cell infusion and evidence of tumour formation at one year in whole body PET scan. Patients were followed at week 1, 4-6, 24 and 52 to determine clinical progress using National Institute of Health Stroke Scale (NIHSS), Barthel Index (BI), modified Rankin Scale (mRS), MRI, EEG and PET. Feasibility outcomes included target-dose feasibility. Favourable clinical outcome was defined as mRS score of 2 or less or BI score of 75 to 100 at six months after stem cell therapy. Results: Between September 2006 and April 2007, 11 patients were infused with bone-marrow mononuclear cells (mean 80 million with CD-34+ mean 0.92 million). Protocol was target-dose feasible in 9 patients (82%). FDG-PET scan at 24 and 52 wk in nine patients did not reveal evidence of tumour formation. Seven patients had favourable clinical outcome. Interpretation & conclusions: Intravenous bone marrow mononuclear cell therapy appears feasible and safe in patients with subacute ischaemic stroke. Further, a randomized controlled trial to examine its efficacy is being conducted.

Laparascopic cholecystectomy: cystic duct occlusion with titanium clips or ligature? A prospective randomized study.

During laparoscopic cholecystectomy (LC), cystic duct occlusion can be done with titanium clips or laparoscopically tied knots. However, till date, there is no randomized, controlled study reported in the literature that has prospectively compared the outcome using either of these methods. In the present study, 105 patients who were to undergo LC were randomly assigned to two groups. Group I comprised patients undergoing cystic duct occlusion with clips while group II comprised those undergoing cystic duct occlusion with knots. Our aim was to compare the postoperative outcome in both the cases. The incidence of overall bile leak following LC was 4 out of 105 (3.8%) while the leak rate following cystic duct occlusion with clips was 2 out 52 (3.9%), and that following ligature was 2 out of 53 (3.8%). The procedure using ligature took slightly longer time than that using clips. There was no significant difference in the postoperative outcome in either group. The use of ligature is a feasible, safe and cost-effective alternative to the use of titanium clips for cystic duct occlusion during LC.