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.
Holt-Oram syndrome is a rare inherited disorder involving the hands, arms, and the heart. The defects involve carpal bones of the wrist and the thumb and the associated cardiac anomalies like atrial or ventricular septal defects. Congenital cardiac and upper-limb malformations frequently occur together and are classified as heart-hand syndromes. The most common amongst the heart-hand disorders is the Holt-Oram syndrome, which is characterized by septal defects of the heart and preaxial radial ray abnormalities. Its incidence is one in 100,000 live births. Approximately three out of four patients have some cardiac abnormality with common associations being either an atrial septal defect or ventricular septal defect. Herein, we report a rare sporadic case of Holt-Oram syndrome with atrial septal defect with symptoms of heart failure in a forty-five-year-old lady who underwent emergency cardiac surgery for the symptoms.
Background: The anthropometric measurement of the craniofacial region plays an important role in the evaluation of the newborn with dysmorphic features and their corrective surgery. This study was undertaken to establish a baseline craniofacial dataset for the newborn population of Kolkata where it is still lacking. Methods: In this study, we obtained the measurement of 6 distinct parameters (length of nose, height of nose, width of columella, length of philtrum, width of philtrum, oral commissural distance) of craniofacial region of 1860 healthy newborns (both male & female). Their body weight was recorded. We compared the values in both sexes and also in normal & low birth weight babies. Results: Our study shows statistically significant higher values in all parameters except oral commissural distance among male than female newborn. It again results statistically significant higher values of length of nose, length of philtrum and oral commissural distance in normal birth weight newborns than the low birth weight group in both sexes. Conclusion: We here present a set of reference value for the newborn population (both normal & low birth weight) of East India (Kolkata). Nepal Journal of Medical Sciences | Volume 02 | Number 02 | July-December 2013 | Page 125-129 DOI: http://dx.doi.org/10.3126/njms.v2i2.8955
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.
Introduction: Pectus Excavatum usually recognized during infancy and become worse with growing ages. Case presentation: We presented a 6 months old male child to our departmental OPD with complaints of indrawing of anterior chest wall. On physical examination revealed a signicant Pectus Excavatum deformity. There was no other abnormality except the chest wall deformity. An abnormal chest X-ray and CT scan demonstrated leftward displacement of heart and great vessels. Conclusion: Surgery for Pectus Excavatum is specialized and can be done in early childhood with better outcome.
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