Safety profile of bone marrow mononuclear stem cells in the rehabilitation of patients with posttraumatic facial nerve paralysis-a novel modality (phase one trial).

Objectives The objectives of this study were to study the safety profile and role of mononuclear stem cells in the rehabilitation of posttraumatic facial nerve paralysis not improving with conventional treatment. Study Design This is a prospective nonrandomized controlled trial. Study Setting This study is conducted at Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh between July, 2007 and December, 2008. Patients We included eight patients of either sex aged between 18 and 60 years of posttraumatic facial nerve paralysis not improving with conventional treatment presented to PGIMER, Chandigarh between July 2007 and December 2008. Methods All patients underwent preoperative electroneuronography (ENoG), clinical photography, and high-resolution computed tomography (HRCT) temporal bone. All patients then underwent facial nerve decompression and stem cell implantation. Stem cells processing was done in well-equipped bone marrow laboratory. Postoperatively, all patients underwent repeat ENoG and clinical photography at 3 and 6 months to assess for objective and clinical improvement. Clinical improvement was graded according to modified House-Brackmann grading system. Intervention Done All patients of posttraumatic facial nerve paralysis who were not improving with conventional surgical treatment were subjected to facial nerve decompression and stem cell implantation. Main Outcome Measures All patients who were subjected to stem cell implantation were followed up for 6 months to assess for any adverse effects of stem cell therapy on human beings; no adverse effects were seen in any of our patients after more than 6 months of follow-up. Results Majority of the patients were male, with motor vehicle accidents as the most common cause of injury in our series. Majority had longitudinal fractures on HRCT temporal bone. The significant improvement in ENoG amplitude was seen between preoperative and postoperative amplitudes on involved side which was statistically significant (0.041). Clinical improvement seen was statistically significant both for eye closure (p < 0.010) and for deviation of angle of mouth (p < 0.008) at 6-month follow-up in 85% of our patients, far better than the results of previous conventional surgeries. Conclusion Stem cell therapy can be used safely in human beings without any adverse effects on humans, and it appears to be a promising modality for rehabilitation of patients with posttraumatic facial nerve paralysis not improving with conventional surgical treatment but few more clinical series are required for validation.