Phase IV postmarketing surveillance study shows continued efficacy and safety of Stempeucel in patients with critical limb ischemia due to Buerger's disease.

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.

Persistent hiccups - A rare complication of suprahepatic inferior vena cava stenting.

Persistent hiccups has not been reported previously with suprahepatic inferior vena cava (IVC) stenting. Persistent hiccups after palliative oesophageal stenting has been reported. We present a case of a 41-year-old male patient diagnosed with primary Budd-Chiari syndrome who underwent IVC stenting for suprahepatic IVC stenosis. Patient developed transient hiccups post procedure which settled immediately with medications. Patient developed a recurrence of symptoms after a year due to stent migration which led to redo stenting. Post-procedure, the patient developed persistent hiccups which could not be controlled by physiological methods or chlorpromazine and needed baclofen at a dose of 10 mg three times a day. The patient has been symptom-free for the past 2 years. Persistent hiccups may present as a rare complication of suprahepatic IVC stenting due to extrinsic phrenic nerve compression or by direct irritation of the diaphragm. Baclofen has been effective in terminating persistent hiccups in our case.

Pulmonary embolism with aortic saddle embolism: a rare presentation.

We present an uncommon case report of simultaneous pulmonary embolism and aortic saddle embolism. This patient had risk factors for thromboembolic events that included recent surgery for tibia fracture and immobilisation. She underwent emergency bilateral pulmonary artery catheter-directed thrombolysis, followed by bilateral transfemoral embolectomy. The potential benefit of thrombolysis was weighed against the risk of haemorrhage during the surgery after thrombolysis. Treatment guidelines are not well established for such a condition. This case report illustrates our experience and challenges faced in treating this condition.

Stent Graft Placement for Treatment of Prosthetic Graft Outflow Stenosis, a Viable Long-term Solution: A Case Report.

Failing prosthetic grafts in patients undergoing hemodialysis is a common problem. Balloon angioplasty is the first line in treating these stenoses, but it is associated with poor patency rates due to recoil and subsequent restenosis. The use of stent graft implantation has shown very promising early and long-term results as per recent literature. We describe a case of arteriovenous graft outflow stenosis, which led to complete thrombosis of the graft, which was rescued by surgical thrombectomy and stent graft placement across the venous end of the anastomosis with good results.

Efficacy of Cadexomer Iodine in the Treatment of Chronic Ulcers: A Randomized, Multicenter, Controlled Trial.

INTRODUCTION: Due to being hard to heal, chronic ulcers account for high morbidity. OBJECTIVE: This study compares the safety and efficacy of 2 formulations of cadexomer iodine and standard care for the treatment of chronic ulcers. MATERIALS AND METHODS: This prospective, randomized, open-label clinical trial was conducted at 8 cities across 15 institutions in India from March 2016 to March 2017. After screening a total of 145 patients with chronic, recalcitrant ulcers, 124 were randomized to 1 of 3 treatments: 0.9% cadexomer iodine ointment plus standard care (n = 41), 0.9% cadexomer iodine powder plus standard care (n = 43), and standard care alone (n = 40). All patients completed the maximum treatment period of 12 weeks, with the exception of 8 who discontinued during the study period. At the end of the treatment period, endpoints were assessed. RESULTS: The percentage of reduction in ulcer size from baseline to the primary endpoint of 12 weeks was significantly higher with both formulations of cadexomer iodine ointment (94.3% ± 10.6%) and powder (90.4% ± 14.9%) as compared with standard care alone (67.8% ± 21.8%). The percentage of patients with complete wound healing at the end of the 12 weeks was significantly higher in patients treated with both formulations of cadexomer iodine ointment (65.8%) and powder (58.1%) as compared with standard care alone (20.0%). CONCLUSIONS: These results demonstrate that cadexomer iodine, in comparison with standard care alone, increases the percentage of reduction in ulcer size and promotes complete wound healing in chronic ulcers.

Administration of Adult Human Bone Marrow-Derived, Cultured, Pooled, Allogeneic Mesenchymal Stromal Cells in Critical Limb Ischemia Due to Buerger's Disease: Phase II Study Report Suggests Clinical Efficacy.

Critical limb ischemia (CLI) due to Buerger's disease is a major unmet medical need with a high incidence of morbidity. This phase II, prospective, nonrandomized, open-label, multicentric, dose-ranging study was conducted to assess the efficacy and safety of i.m. injection of adult human bone marrow-derived, cultured, pooled, allogeneic mesenchymal stromal cells (BMMSC) in CLI due to Buerger's disease. Patients were allocated to three groups: 1 and 2 million cells/kg body weight (36 patients each) and standard of care (SOC) (18 patients). BMMSCs were administered as 40-60 injections in the calf muscle and locally, around the ulcer. Most patients were young (age range, 38-42 years) and ex-smokers, and all patients had at least one ulcer. Both the primary endpoints-reduction in rest pain (0.3 units per month [SE, 0.13]) and healing of ulcers (11% decrease in size per month [SE, 0.05])-were significantly better in the group receiving 2 million cells/kg body weight than in the SOC arm. Improvement in secondary endpoints, such as ankle brachial pressure index (0.03 [SE, 0.01] unit increase per month) and total walking distance (1.03 [SE, 0.02] times higher per month), were also significant in the group receiving 2 million cells/kg as compared with the SOC arm. Adverse events reported were remotely related or unrelated to BMMSCs. In conclusion, i.m. administration of BMMSC at a dose of 2 million cells/kg showed clinical benefit and may be the best regimen in patients with CLI due to Buerger's disease. However, further randomized controlled trials are required to confirm the most appropriate dose. Stem Cells Translational Medicine 2017;6:689-699.

Composite sequential bypass using profunda vein hitchhike.

Patients with long-segment occlusions of the iliac and femoral arteries often undergo sequential bypass procedures. There exists a subgroup of patients who have no suitable vessels in the groin. We report our experience with a new technique of using the profunda vein as a hitchhike point in our series of seven patients (eight limbs) with critical ischemia and occlusion at the iliac or aortic level with reformation of infrageniculate arteries and no reformation in the groin. The proximal graft was anastomosed to the profunda vein, which was ligated proximal to the anastomosis. The saphenous vein graft was taken from the distal end of the polytetrafluoroethylene graft and anastomosed to the appropriate tibial arteries. The procedure was technically successful in all the patients. The median follow-up was 8 months (range, 0-30). The profunda vein as a hitchhike point gives an excellent outcome in the short and medium term in this uncommon group of patients.