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  Citation statistics : Table of Contents
   2017| January-March  | Volume 2 | Issue 1  
    Online since April 4, 2017

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Use of PIXYL software analysis of brain MRI (with & without contrast) as valuable metric in clinical trial tracking in study of multiple sclerosis (MS) and related neurodegenerative processes
Robert W Alexander
January-March 2017, 2(1):1-6
Multiple sclerosis (MS) is a complex inflammatory disorder of the brain and spinal cord in which focal lymphocytic infiltrates lead to damage of myelin and axons. Often this seems associated with a type of autoimmune and inflammatory disorder which is transient, with attempted remyelination that is not durable. Neurological disorders appear somewhat randomly, seem to improve and demonstrate recovery. Progression is variable, but over time, seems to become more widespread with microglial activation associated with extensive chronic neurodegeneration and persistent disability. Magnetic resonance imaging (MRI), with and without contrast, has become the standard metric of finding and following lesions and axonal loss. The traditional methods of treatment include medications, diet, exercises, and neurological supportive care. The medications are limitedly effective, and often have very undesirable side effects. Medications seem to reduce the frequency of new episodes, but are not yet able to reverse acquired deficits or long-term progression. Clinical trials exploring cellular therapy are currently underway, and showing some interesting progress with management of many with the MS disorder. What has been needed is a reliable and affordable metric to track the patient's clinical progress, both from a location of lesion and volumetric changes on MRI. PIXYL software offers a major improvement in providing tracking capability of outcomes in use of medications or cellular therapy. Time consuming, limited accuracy, and costs of having serial MRI segmented and analyzed make standing neuroradiological interpretations difficult to standardize. This software offers a new ability to resolve much of these issues, including taking manual (human) interpretation out of potential bias or different interpreters, and offers volumetric and lesional changes over time in serial studies. This paper introduces the functions and values of use of sophisticated software analytics in the evaluation and management of this ongoing disease process.
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Impact of incretin-related agents on endothelial cell function
Hiroshi Nomoto, Hideaki Miyoshi, Akinobu Nakamura, Tatsuya Atsumi, Naoki Manda, Yoshio Kurihara, Shin Aoki, on behalf of SAIS Study Group
January-March 2017, 2(1):7-11
Incretin-related drugs, such as dipeptidyl peptidase-4 (DPP-4) inhibitors and glucagon-like peptide-1 (GLP-1) analogues, have been clinically available and widely used to treat patients with type 2 diabetes mellitus. Accumulating evidence indicates that these agents exert glycemic control and have various other favorable effects, including prevention of atherosclerosis. It is important to assess and manage early-phase atherosclerosis, but whether diabetic therapeutics including incretin-related drugs improve or maintain vascular endothelial cell function has not been fully determined. We previously published prospective clinical trials focused on flow-mediated dilation in patients with type 2 diabetes, who did not have severe atherosclerosis, using two different incretin-related drugs: a DPP-4 inhibitor and a GLP-1 analogue. These trials showed that these therapeutic agents did not improve endothelial cell function. In this article, we discuss how incretin-related drugs contribute, if at all, to vascular endothelial cell function, atherosclerosis, and beta-cell function, based on our clinical trials and previous evidence.
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Diabetes – wholistic ayurvedic approach
Sujata Vaidya
January-March 2017, 2(1):18-19
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Information for Authors – Clinical Trials in Degenerative Diseases

January-March 2017, 2(1):20-30
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Autologous CD34+ cell transplantation promotes angiogenesis in older adult patients with atherosclerotic ischemia: study protocol for a randomized controlled trial
Li-li Xu, Chen-hong Zhou, Xiao-jie Tan, Ming-jin Guo, Li-kun Zhang, Pei Zhang, Bing Liu
January-March 2017, 2(1):12-17
Background: The main clinical manifestation of senile arteriosclerosis obliterans is lower limb ischemia, which is currently difficult to treat. One method is autologous stem cell transplantation into the muscles of ischemic limbs to improve the formation of new capillaries and restore lower limb blood flow. Endothelial progenitor cell marker CD34+ cell transplantation has been shown to promote angiogenesis in ischemic limbs. Therefore, we propose that peripheral blood autologous CD34+ cell transplantation in older adult patients with atherosclerotic ischemia could effectively promote angiogenesis. Methods/Design: We propose to conduct a prospective, single-center, open-label, randomized, and controlled clinical trial at the Qingdao No. 9 People's Hospital, China. Twenty older adult patients with atherosclerotic lower limb ischemia will be randomized into two groups. In the cell transplantation group (n = 10), peripheral blood CD34+ cells transfected with vascular endothelial growth factor 165 (VEGF165) gene will be transplanted into the muscles of ischemic limbs in older adult patients with atherosclerotic lower limb ischemia. In the control group (n = 10), physiological saline will be injected into the muscles of ischemic limbs. Patients will be followed up for 6 months. The primary outcome will be ankle-brachial indices before and 6 months after transplantation to assess lower limb ischemia in both groups. The secondary outcomes will be the number of microvessels in the lower limb muscles before and 6 months after transplantation, the morphology of new blood vessels revealed by CT angiography, the number of VEGF-immunoreactive cells 6 months after transplantation and the incidence of adverse reactions. Discussion: This trial will begin in January 2018 and finish in December 2019. We aim to quantify the effects of VEGF165 gene-modified CD34+ cell transplantation in the treatment of older adult patients with atherosclerotic ischemia to develop a new effective treatment of lower limb ischemia. Trial registration: ClinicalTrials.gov identifier: NCT03098771. Ethics: The study protocol has been approved by the Ethics Committee of Qingdao No. 9 People's Hospital of China. All protocols will be in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Written informed consent will be provided by participants.
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