Efficacy and outcome of bone marrow derived stem cells transplanted via intramedullary route in acute complete spinal cord injury - A randomized placebo controlled trial.

Due to lack of well-designed trials, there is no good evidence on the efficacy of stem cells in spinal cord injury. We aim to study the efficacy and outcome of bone marrow derived stem cells (BMSCs) in acute complete spinal cord injury (SCI). In this prospective study over a 3-year period, 27 patients with acute, complete SCI were randomized to receive BMSCs or placebo (intramedullary route) intraoperatively. Institutional ethics approval was taken and informed consent was taken from all patients. Functional outcome was assessed using ASIA scale, SCIM score and SSEP responses preoperatively, three and six months after surgery. Thirteen patients were available for final analysis of which six were in the stem cell group and seven received placebo. 6 patients had improvement by at least one grade in ASIA score in the stem cell group as compared to only one patient in the placebo group. However, no functional motor improvement in any of the patients. ASIA sensory score improved from a preoperative mean of 124 to 224 at 6 months compared to the static mean of 115 in the control group. Absent SSEP waveform converted to abnormal waveform at 6 months in 3 patients in the stem cell group and one patient in the control group. There was no significant difference in the SCIM scores between the groups at last follow-up. All patients in the stem cell group reported improved bladder sensation, decreased spasticity and improved posture control as compared to nine in the placebo group. BMSCs through intramedullary route are a potential therapy for acute complete SCI and more research is required in this area.

Cost-Effective Home Mechanical Ventilation in Neurosurgery Patients: Case Series of Three Patients.

Background Neurological patients who are ventilator-dependent occupy scarce beds in the hospitals for prolonged periods of time. Most, if not all, can be discharged on home mechanical ventilation (HMV). However, due to lack of insurance and state support, it remains prohibitively expensive for the vast majority of those who require it most. Materials and Methods The authors discuss three patients admitted in the Department of Neurosurgery between January and August 2019, who were discharged on HMV after remaining on ventilator support for prolonged period in the hospital. Each patient was discharged with two units (one as standby) of AgVa home ventilator (AgVa Healthcare; New Delhi, India), one Ambu-bag, one pulse oximeter, and one backup power supply unit capable of supplying power to ventilator for a minimum of 24 hours. All the equipment were given free-of-cost through donations by hospital staffs and other donors. All patients were followed up telephonically from their homes and the incidence of complications, ventilator malfunction, and additional cost of HMV on the families were ascertained. Observation and Results Of the three patients, two were male and one female. Age ranged from 12 to 17 years. The duration of in-hospital ventilator support prior to discharge on HMV varied from 1 to 5 years. There was no insurance cover available for any of the patients with all expenses being "out of pocket." The equipment cost Indian Rupees (INR) 115,700 (USD 1,615: two units of AgVa home ventilator costing INR 100,000 [USD 1,396], one Ambu-bag costing INR 1,100 [USD 15], one pulse oximeter costing INR 1,600 [USD 22], and one backup power supply unit costing INR 13,000 [USD 182]). Discharge on HMV was planned on specific request from patients' families and informed consent was taken from all. All patients had tracheostomies. Mode of HMV was pressure support ventilation in all. Telephonic follow-up ranged from 1 to 7 months. The cost of disposables was INR 100 per month (USD 0.7) for all the patients. No complications occurred in any patient. There was no incidence of ventilator-associated pneumonia (VAP) or ventilator malfunction. Conclusions Availability of cost-effective indigenous ventilator like AgVa home has made HMV possible, even for poor patients with neurological diseases, and has the potential to improve quality of life, decrease VAP rates, and free up scarce ventilator beds in hospitals. Longer-term follow-up in larger number of patients will improve the data on safety and feasibility in developing countries like India.