Buerger's disease or thromboangiitis obliterans is a type of obstructive vascular diseases categorized as vasculitis and usually present in 95% of young smoker men. The main pathogenetic mechanism is interplay between immune system and inflammation. Earlier our phase II study has shown that Stempeucel is safe when injected at 2 million cells/kg body weight by virtue of its anti-inflammatory, immunomodulatory, and angiogenetic properties. The present study was conducted to further assess the safety and efficacy of Stempeucel in critical limb ischemia due to Buerger's disease after obtaining approval from Indian FDA based on the data generated in the phase II study. This is an open label, multicenteric phase IV PMS study conducted across India with experienced vascular surgeons. Fifty patients of critical limb ischemia due to Buerger's disease with Rutherford III-5 or III-6 were included in the study and each individual received a dose of 2 million cells/kg body weight of Stempeucel in the calf muscles and around the ulcer. These patients were evaluated over 12 months from drug administration. The present study showed the continued long term efficacy over a period of 12 months follow up in these patients corroborating the result obtained in the previous phase II studies. There was significant improvement in rest pain, ankle systolic pressure, and ankle brachial pressure index with accelerated ulcer healing. In conclusion, the present study shows that the intramuscular administration of Stempeucel continues to be safe, tolerable, and effective alternative treatment in patients with Buerger's disease.

Background Peripheral arterial disease (PAD) of lower extremities comprises a clinical spectrum that extends from asymptomatic patients to critical limb ischemia (CLI) patients. 10% to 40% of the patients are at the risk of primary amputation. This study was planned in “no-option” patients of CLI due to atherosclerotic PAD to assess the efficacy and safety of pooled, allogeneic, adult human bone marrow-derived mesenchymal stromal cells which is already approved for marketing in India for CLI due to Buerger’s disease. Methods This was a single-arm, multi-centric, phase III study where mesenchymal stromal cells was injected as 2 million cells/kg body weight in the calf muscle and around the ulcer. Twenty-four patients of lower extremity CLI due to PAD with Rutherford III-5 or III-6 and ankle–brachial pressure index ≤ 0.6 and having have at least one ulcer with area between 0.5 and 10 cm2 were included in the study. These patients were evaluated over 12 months from drug administration. Results Over a period of 12 months, statistical significant reduction of rest pain and ulcer size along with improvement in ankle–brachial pressure index and ankle systolic was observed. The quality of life of patients improved together with increase in total walking distance and major amputation-free survival time. Conclusion Mesenchymal stromal cells may be a feasible option to treat “no-option” patients with atherosclerotic PAD. Trial registration This study is registered prospectively in National Institutes of Health and Clinical Trials Registry—India (CTRI) website: CTRI/2018/06/014436. Registered 6th June 2018. http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=24050&EncHid=&userName=stempeutics.

IntroductionAutism spectrum disorder (ASD) is a neurodevelopmental disorder, and a tremendous increase in the incidence of autism poses challenges in identifying the different treatment modalities. Since the defined etiology, pathophysiology, and treatment of autism are unavailable, translational research is being done by creating animal models of autism. This study aimed to assess the effects of Acorus calamus on developmental and histopathological changes in autism-induced Wistar rats. Materials and methodsA rat model of autism was created by administering sodium valproate on the 12th day of pregnancy, and rat pups of this group were considered autism-induced. Rat pups of pregnant rats who had received normal saline on the 12th day of pregnancy were considered group I (negative control group). Neural reflexes were assessed in early postnatal days (PND) to confirm the development of autism. Autism-induced rat pups were divided into the following two groups: group II, autism (positive control group), and group III, autism + A. calamus (drug-treated group). On the 21st postnatal day (PND), group III was given an ethanolic extract of A. calamus (200 mg/kg), and group I and group II were given normal saline orally for 15 days. After 15 days of drug exposure, at 36th PND, the rats were sacrificed, and brain tissue was collected for histopathological analysis. ResultsWhen compared to the negative control group, autism-induced rat pups showed delayed appearance of neurological reflexes. Neurodegenerative changes were well appreciated in group II (autism-induced rats) than in group III (autism + A. calamus). In the histomorphometric analysis, group II showed a significant reduction in the number of neurons in the frontal cortex and Purkinje cells in the cerebellum. However, when compared to group II, group III (autism treated with A. calamus) did not show significant alteration. ConclusionValproate exposure at mid-pregnancy creates autism by disturbing neural structures among rat pups. This was clinically represented as the delayed appearance of neural reflexes. Acorus calamus in the early postnatal period protects rat pups' brain morphology against autism pathology.

Night shifts work in particular is the most frequent reasons for circadian rhythm disruption and subsequent psychological and physiological disturbances, especially increased risk of cardiovascular and respiratory ailments compared to daytime workers. Alternate nostril breathing for about 15 minutes was known to have effect over cardiac, respiratory parameters and muscle strength. Hence aim is of interest to assess the effects of alternate nostril breathing (ANB) on cardiorespiratory parameters and muscle strength among the rotating shift workers in the tertiary care hospital. This observational study was carried out in the department of Physiology after getting institutional ethical committee clearance. Around 140 rotating night shift workers of both sex of age 25-40 years with normal BMI and 140 non-shift workers age, sex and BMI matched were selected as study and control group respectively. Heart rate, blood Pressure, respiratory rate, peak expiratory flow rate, respiratory endurance, respiratory burst test, muscle strength and fatigue were recorded before and after 15 minutes of ANB. Shift workers were found to have significantly altered systolic (P=0.000) and diastolic (P=0.002) blood pressure and heart rate (P= 0.010) compared to non-shift workers. All the cardiorespiratory parameters and muscle strength, fatigue was found to be significantly (P< 0.05) altered after ANB between both shift and non- shift workers. ANB can be used as a therapeutic module among the shift workers, to maintain their sound health and to improve their performance in the night duty.

Night shifts work in particular is the most frequent reasons for circadian rhythm disruption and subsequent psychological and physiological disturbances, especially increased risk of cardiovascular and respiratory ailments compared to daytime workers. Alternate nostril breathing for about 15 minutes was known to have effect over cardiac, respiratory parameters and muscle strength. Hence aim is of interest to assess the effects of alternate nostril breathing (ANB) on cardiorespiratory parameters and muscle strength among the rotating shift workers in the tertiary care hospital. This observational study was carried out in the department of Physiology after getting institutional ethical committee clearance. Around 140 rotating night shift workers of both sex of age 25-40 years with normal BMI and 140 non-shift workers age, sex and BMI matched were selected as study and control group respectively. Heart rate, blood Pressure, respiratory rate, peak expiratory flow rate, respiratory endurance, respiratory burst test, muscle strength and fatigue were recorded before and after 15 minutes of ANB. Shift workers were found to have significantly altered systolic (P=0.000) and diastolic (P=0.002) blood pressure and heart rate (P= 0.010) compared to non-shift workers. All the cardiorespiratory parameters and muscle strength, fatigue was found to be significantly (P< 0.05) altered after ANB between both shift and non- shift workers. ANB can be used as a therapeutic module among the shift workers, to maintain their sound health and to improve their performance in the night duty.