Scientific Program

Day 1 :

  • Diabetes Mellitus | Endocrine Hormones | Genomic Endocrinology

Session Introduction

Amer Alata

Medical Director-Via Medical International Healthcare, UAE

Title: Proposed Management of Quality Outcomes for Obesity and Diabetes in the UAE
Speaker
Biography:

Dr. Amer Alata is currently working as the Medical Director at Via Medica International Healthcare. Dr. Alata received his MD from Ross University School of Medicine. Dr. Alata completed his Bachelor degree from the University of Michigan – Dearborn, in the USA. He then managed a chain of Urgent Care clinics in different cities in Michigan. He dedicated 4 years to education working at Detroit Business Institute in Downriver, Michigan as both an instructor and the Medical Programs Director. Dr. Alata moved to the UAE early 2015 and is now working as the Medical Director for Via Medica International Healthcare, managing different sectors of healthcare, providing patient education, and ensuring high quality delivery of healthcare. He is a member of the American Heart Association and American Stroke Association, as well as the Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation.

Abstract:

According to the UAE 2021 Vision, launched by H.H. Sheikh Mohammed bin Rashid Al Maktoum, Vice-President and Prime Minister of the UAE and Ruler of Dubai, the country is to be among the best countries in the world by the Golden Jubilee of the Union. Six national priorities representing key focus sectors have been determined; amongst which is World-Class Healthcare. Under the sector of World-Class Healthcare, there are indicators for the prevalence of Diabetes, however there is no key indicator or outcomes for Obesity, except for the prevalence of Obesity amongst children. Other indicators include the prevalence of smoking any tobacco product, number of death from cancer per 100,000 population, average healthy life expectancy, and the number of deaths from cardiovascular diseases per 100,000 population, amongst others.  The last mentioned indicator in this abstract; that is the number of deaths from cardiovascular disease, correlates directly with Obesity. The results for this indicator are 297.6 deaths per 100,000 population; according to the World Health Organization (WHO) report for the 2012 figures published in the 2014 report, sponsored by the Ministry of Health and Prevention. The same report by the WHO indicates that the proportional mortality (% of total deaths, all ages, and both sexes) from cardiovascular diseases is at 30% and for Diabetes is only 3%. Looking at the prevalence of Diabetes, which is “an indicator that measures the number of people between the ages of 20 and 79 with Diabetes in the UAE, as a proportion of the total population, with this age group being aligned with the age group used by the International Diabetes Federation,” it stands at 19.3% for the year 2015. In other words, approximately 1 in 5 UAE nationals had Diabetes in 2015. The UAE is determined to cut down on the prevalence of Diabetes from 19% to 16% by 2021. Proposed methods will be presented to cut down on both Diabetes and Obesity in the UAE will be presented.

Speaker
Biography:

Dr. Bernadette Dian Novita is a medical doctor and lecturer in Widya Mandala Catholic University Surabaya Faculty of Medicine, her major is Pharmacology and Therapy, focusing in diabetes mellitus, infection and immunology. She has completed her PhD from Airlangga University Faculty of Medicine. She has got several national and international publications in diabetes mellitus area.

Abstract:

Poor glycemic control in Diabetes Mellitus (DM) patients has the potential to modify the risk of TB. In our knowledge, high glycemic index increases superoxide dismutase (SOD) for balancing oxidative stress – reactive oxygen species (ROS) production. Metformin (MET), one of glycemic control drug, has effect in increasing SOD level and expects to contribute in the Isoniazid (INH)-induced bactericidal by increasing activation of INH pro-drug. However, the optimal glycemic control during anti TB therapy in DM-TB infection remains unknown. An observational clinical study was done in DM-TB infection outpatients at Surabaya Paru Hospital. Glycemic index (HbA1c) evaluation was obtained during a 2-month MET therapy accompanying with insulin and anti TB. As a comparison, control group, whom were not given MET, was also evaluated. The smear was measured two times as diagnostic and as evaluation. Superoxide Dismutase (SOD) level were also evaluated before and after this observation period. From 42 participants in this study, 22 participants of observation group that received additional MET therapy, 100% had sputum smear reversion conversion after 2-months intensive phase of anti TB therapy. Whereas 25% of 20 participants of comparison group did not undergo reversion inserts sputum smear and needed additional anti TB . Smear reversion was significantly difference, using Fisher’s exact test, between the MET group and the control group. Moreover, SOD level was significantly different between MET group and the control group in HbA1c around 8,35%. Thus we concluded that MET is a potential additive therapy to enhance the bactericidal effect of anti TB on DM infected patients. Slightly poor-controlled glycemic index might contributed in enhanced anti TB activity. However, since the number of samples was limited in this study, cohort study need to be applied to support this data.
Keyword : type 2 diabetes mellitus-tuberculosis co-infection, metformin, AFB smear reversion, glycemic index and SOD

Speaker
Biography:

Dr. Al-Jebawi is a consultant endocrinologist & director of Diabetes Care Center/ Saint Vincent Hospital in Anderson, Indiana/USA. He is also a clinical assistant professor at Indiana University School of Medicine in Indianapolis, Indiana/USA. He was certified by the American Board of Internal Medicine in 1996 and 2008. He was also certified by the American Board of Endocrinology in 1998 and 2008. He is a fellow of American College of Endocrinology and the American College of Physicians. He is the editor of the book: "Glucagon: Structure, Biosynthesis and Physiological Effects".  Nova Science Publishers, Inc. and a reviewer of "Journal of Postgraduate Medicine". He served as the director of "Diabetes Diploma Program" at Joslin Diabetes Center "Now, Dubai Diabetes Center" during the period Aug 2008-2013. In addition to his publications on Glucagon, he published on the PTH responsiveness to vitamin D deficiency among patients suffering from type 2 diabetes. He also served as a principal investigator in many clinical trials in USA.

Abstract:

Vitamin D deficiency and diabetes represent two of the most common metabolic health problems in the world. Although the association between diabetes and vitamin D deficiency has been proved, it is still unclear whether it is a cause and effect relationship or if vitamin D deficiency is merely a consequence of obesity. Since hypovitaminosis D causes a compensatory increase in the secretion of PTH; calcium levels usually remain within the normal limits. Several factors have been demonstrated to modify the serum PTH response to low circulating 25(OH) vitamin D. In this cross sectional study, we showed that chronic hyperglycemia is associated with a lower parathyroid hormone level among patients with vitamin D deficiency and type 2 diabetes without causing any significant changes in calcium levels. In contrast, regression analysis did not show a significant association between fasting plasma glucose and the responsiveness of PTH to vitamin D deficiency. Our data showed that there is a significant association between PTH level and the interaction (the product) of HbA1c and 25(OH) vitamin D. Interestingly, the chronic hyperglycemia associated attenuation of PTH secretion was only seen among subjects (males and females) who are older than 50 years of age. The following model predicts PTH level for subjects who are older than 50 years of age: PTH= 34:153-0:680 VitD-2:523 HbA1c.%.; p < 0:003.

Speaker
Biography:

Satendra Kumar Multani is a Consultant Endocrinologist in Prime Medical Center, UAE.

Abstract:

The South Asians constitutes more than 50% of UAE population. The prevalence of diabetes in South Asian population in UAE is same as that in Local Emirati population i.e around 20%. The South Asians develop T2DM at much younger age, at much lower BMI due to many genetic and environmental factors. The cut offs for normal BMI and Waist circumference are much lower in South Asians & at any given BMI South Asians have more fat and less muscle mass in body.   Central obesity and clustering of CV risk factors are much more common in this population leading to increased prevalence of Macro and micro-vascular complications at much younger & productive age. The main challenges in managing T2DM in South Asians are their food habits, poor physical activity traits & selection of right medications. There are many cultural and religious issues which are to be tackled with proper education while treating this population.

Speaker
Biography:

Irina Kurnikova - MD, PhD, Professor of Medicine, RUDN University (Peoples Friendship University of Russia), Moscow, Russia. She has extensive experience in the field of scientific and practical Endocrinilogy. Dealing with Problems of Endocrinology more than 20 years.  The main areas of her research are the optimization of the system approach to the treatment and rehabilitation of patients with diabetes mellitus, diseases of the thyroid gland, disturbances in the system of regulation of the organism and other endogenous factors (comorbidity, interstitial humoral transport et al.). Currently teaches at Peoples' Friendship University of Russia, curator of the scientific direction of endocrinology.  Has published more than 20 articles in well-known journals, the author of 25 books and manuals in Russian, 10 patents for inventions.

Abstract:

Statement of the Problem: the "complexity category" of patient management increases many times, if the somatic disease had combined with multi-organ systemic disease, such as diabetes mellitus (type 1 diabetes - DT1 and type 2 diabetes - DT2).  Simultaneous formation of several diseases in a patient: arterial hypertension, atherosclerosis, ischemic heart disease and diabetes mellitus, creates not only significant difficulties in diagnosis, but affects the quality of care and worsens the prognosis. The purpose of this study is to study the influence of somatic pathology on the level of glycemic control indices of patients with diabetes mellitus from the viewpoint of cause-effect relationships and mechanisms of polymorphic formation. Methodology & Theoretical Orientation: A special complex examination of patients was conducted.  The control of carbohydrate metabolism was provided in accordance with the recommendations of WHO by repeatedly examining the glycemic profile and glycated hemoglobin (HbA1c).  The comorbidity was assessed according to the CIRS - Cumulative Illness Rating Scale. Findings: in our study, the risk of developing concomitant cardiovascular disease had a positive association with DT 2 (RR = 3.4, p <0.001), and the chances of developing a cardiovascular pathology in DT 2 were significantly higher (OR = 15.7;  X² = 151.6).  The multiplicity of complications was significant in patients with DT1 (RR = 1.96, p = 0.095) and 3 times increased the risk of cardiovascular disease (OR = 3.47, p = 0.008), but for DT2 this criterion had a weak  negative association for RR (RR = 0.86, p <0.001) and influenced the increase in odds (OR = 0.39; p = 0.03).  The duration of the course of DT1 for more than 10 years contributed to an increase in the relative risk and odds ratio (RR = 3.43, p <0.001, OR = 8.29, CI 95% 4.36-15.76) for pathology formation.  Almost 3 times increased risk of cardiovascular disease in patients with DT2 with a BMI more than 30 (RR = 2.95, p = 0.063).  The risk of cardiovascular disease in case of unsatisfactory compensation of CD1 (RR = 1.16, p = 0.021, OR = 1.27), DT2 (RR = 1.39, p <0.001, OR = 2.28).  However, to assert that the risk of developing concomitant cardiovascular pathology increases the fluctuations in the level of glycemia in patients with diabetes (OR DT1 = 2.19, CI 95% 0.46-10.45, ORSD2 = 5.93 CI 95% 0.75-46,  91) with the obtained CI level of 95% is not possible.  The significance of lipid metabolism disorders (atherogenicity index) in the development and progression of coronary pathology in diabetic patients was confirmed, and this factor was much more significant in patients with DT1 (OR DT1 = 11.4; OR DT2 = 30.9).Compensation of diabetes by glycemic values depended on the duration of the disease of DT 2 (r = 0.42, p <0.05), the severity of comorbidity, and corresponded to the degree of comorbidity (r = 0.67, p <0.05) in Cumulative Illness Rating  Scale (CIRS). For basal glycemia, at the beginning and after treatment, the correlation coefficient (r) is 0.56 and 0.67, respectively. For postprandial glycemia - 0.45 and 0.35, respectively (p <0.05).  The relationship between the values of basal glycemia and the indicators of comorbidity after the completion of the course of treatment is strengthened, and postprandial - decreases.  Rates of basal glycemia reached normal values only in patients with low CIRS.  At high values of CIRS (14 or more points), it was not possible to normalize the parameters of carbohydrate metabolism in the majority of patients Conclusion & Significance: somatogenic pathomorphological disturbances have a fundamental effect on the course of diabetes, which in turn is a risk factor for the development and progression of somatic pathology. The level of comorbidity should be taken into account when determining the target level of glycated hemoglobin. One of the options for a quantitative criterion can be the definition CIRS. The higher the comorbidity, the less rigid the target values of HbA1c.
  

  • Endocrine Disorders | Diabetes and Oral health problems | Cardiovascular Complications

Session Introduction

V V Babenko

State Institution of Heart Institute by the Ministry of Health. Ukraine

Title: Metabolic syndrome and acute ischemic stroke: predictors of functional outcome.
Biography:

V V Babenko, State Institution of Heart Institute by the Ministry of Health of Ukraine, Kyiv, Ukraine.

Abstract:

INTRODUCTION: The aim of study was to establish predictors of functional outcomes of acute ischemic stroke (IS) in patients with metabolic syndrome(MS). METHODS: 202 patients with MS and clinical manifestations of IS were perfomed. The functional outcome after acuit IS was assessed by the modified Rankin scale: 0-1 point –favorable functional outcome (FFO), 2-6 points–unfavorable outcome (UnFO). RESULTS:After IS, the ratio of patients experiencing FFO comprised 48% and UnFO–52%. Statistically significant (p<0,001) main predictors and clinical indicators of AFO after acute IS in patients with MS: NIHSS scale ≥10 points (relative risk (RR) 3.61; p<0,0001),and Bartel index ≤40 points (RR 2.76; p<0,0001); level Glasgow Coma Scale ≤13 points (RR 3.61; p<0,0001); complex intima-media (RR 2.37; p<0,0001); infarct zone≥25,3cm3(RR 3.09; p<0,0001);level of fasting blood glucose ≥7,6mmol/L (RR 2.4; p<0,006); reduction level of HDL lipoproteins (RR 2.37; p<0,0001);occurrence of atherothrombotic(RR 2.21) and cardioembolic subtype(RR 2.41; p<0,0001); ischemic heart disease(RR 1.69; p<0,045); total number components of MS (RR 1.5: p<0,05).
SUMMARY:The most important significant predictors of UnFO after acute IS of patients with MS were definded.
 

  • Nephropathy | Pancreatic Cancer |
Speaker
Biography:

Yasser M Hafez has completed his PhD at the age of 35 years from school of medicine, Tanta University. He is a lecturer of internal medicine, Diabetes and Endocrinology unit. He has published this paper in reputed journal.

Abstract:

Diabetic  nephropathy  (DN)  is  one  of  the  major  causes  of  end-stage  renal  disease.  Nod-like receptors  nucleotide-binding  domain  and  leucine-rich  repeat  pyrin-3  domain  (NLRP3) inflammasome  displays  a  considerable  role  in  the  chronic  inflammatory  state  observed  in diabetic patients. Urinary heat shock protein 72 (uHSP72) is a sensitive and specific biomarker for the early detection the acute kidney injury.  The  aim  of  this  study  was  to  evaluate  NLRP3 relative  gene  expression, its correlation with inflammatory  and oxidative stress markers,  and to assess the value of uHSP72 in the early detection of DN in type 2 diabetic patients with different degrees  of  DN.  Forty-five type 2 diabetic patients were enrolled in this study:  15 normoalbuminuric; 15 microalbuminuric; 15 macroalbuminuric patients in addition to 15 healthy controls. Clinical examination and routine laboratory investigations were done.  NLRP3 mRNA expression was assessed by real time PCR. Serum 8-hydroxy-2’-deoxyguanosine (8-OHdG), IL-1β and uHSP72 levels were estimated by enzyme-linked immunosorbent assay.  Serum chitotriosidase  (CHIT1)  activity  was  examined.  Significant  higher  NLRP3  mRNA  expression, serum  8-OHdG,  IL-1β  and  uHSP72  levels,  in  addition  to  CHIT  1  activity were  documented  in the  macroalbuminuric  patient  group  as  compared  to  the  other  two  diabetic  and  control  groups. They  were  significantly  positively  correlated  and  to  urinary  albumin/creatinine  ratio,  serum creatinine  and  HA1c.  Multiple  linear  regression  analysis  using  UACR  as  dependent  variable, confirmed that uHSP72, and relative NLRP3 mRNA expression were the independent predictors of  DN  (β  were  0.432  and  0.448  respectively,  P<0.001).  Receiver  operating  characteristic analyses  revealed  that  both  NLRP3  mRNA  expression  and  uHSP72  levels  were  useful biomarkers  discriminating  DN  patients  from  T2DM  patients  (AUC  were  0.957  and  0.983 respectively) Conclusion: uHSP72 may be considered as a novel potential diagnostic biomarker for  the  early  detection  of  DN.  Moreover,  these  data  support  the  pivotal  role  of  NLRP3  in  the development and progression of DN.

Day 2 :

  • Endocrine Cancer | Reproduction Pregnancy and Development | Diabetic Therapies

Session Introduction

Fazlarabbi Khan

Head Specialty Care Business, Sandoz Division

Title: Role of peer support in Diabetes care
Speaker
Biography:

A dynamic Health Care executive over 15 years of diversified experience in Sales & Marketing, Development of Brand Strategies, Leading people, People Development and Project Management in reputed multinational pharmaceuticals companies. Strengths includes the ability to accurately assess situations, create a vision, make difficult decisions, collaborate with executive stakeholders, impeccably execute strategic and tactical plans, coach & develop current and future leaders. Presently, working as Head of Specialty Care at Sandoz division, Novartis Bangladesh Limited since December 2015. Previously worked at Sanofi Bangladesh Ltd. as Business Unit Manager, headed a team consists of Senior Product and Sales Managers including managing a diversified portfolios.

Abstract:

The prevalence of type 2 diabetes mellitus (DM) among adults in the South-East Asia region was estimated to be 8.5% in 2015 and is projected to rise to 10.7% by 2040 (IDF Diabetes ATLAS, 2015). Until a decade ago, diabetes was not considered a major public health problem in developing country, like Bangladesh. Treatment of type 2 diabetes with modern drugs may improve diabetes care; however, this therapy is far from preventing micro- or macro vascular complications effectively. This suggests that there is a strong need to intensify lifestyle intervention and motivate patients to better manage diabetes by themselves. A study was conducted in 2011 on impact of diabetes education program on knowledge and perception among type 2 diabetes in Bangladesh and found that diabetes education provided by professionals enhanced the knowledge of patients and changed their attitudes towards all aspects of DM though it did not help them to improve their diabetes self-care activities except only doing physical exercise and quieting smoking. A successful effective disease management depends on sustainable patient self-management behaviors, emotionally coping with severity of living with diabetes. For professional health workers, it is often impossible or too costly to provide this support on a one-on-one basis. Disease management approaches that incorporate peer support may be a promising way to provide self-management support to patients with diabetes. The World Health Organization (2007) defined “peer support” as an economic, flexible intervention for improving diabetes care and outcomes. In a simple word, people with diabetes could be chosen to educate other patients with diabetes is called peer support. Peers can provide ongoing support that is needed for sustained self-management of diabetes. In this context, peers are nonprofessionals who have diabetes. Key functions of effective peer support include assistance in daily management, social and emotional support, linkage to clinical care, and ongoing availability of support. Using these four functions as a template of peer support, we evaluated the effectiveness of a diabetes education program guided by the professionals vs peer leaders in improving diabetes care among patients with type 2 diabetes in Bangladesh in 2012. Our initial assessment found improvements in the glycemic management, blood pressure, body mass index, and understanding levels of the consequences of uncontrolled diabetes among those who failed to achieve the goals. Peers play a unique role that supplements and supports the clinical care. For policy makers, the broader message is that by emphasizing the role of peer support in diabetes care can be successfully achieve the self-management efficacy in patients with type 2 diabetes across varied cultural settings and within diverse healthcare systems.

  • Diabetic wound and Surgery Management | Obesity and Diet Managements | Nutrition Development and Research

Session Introduction

WANG Hong-sheng

Beijing MEBO Institute of Burns Wounds & Ulcers, China

Title: Brief Analysis on Wound Management and Treatment Standard of Diabetic Foot Based on the 102 Cases Healed by MEBT
Biography:

Beijing MEBO Institute of Burns Wounds & Ulcers ,Beijing 100020, China (WANG Hong-sheng)

Abstract:

Objective  To investigate the standards of clinical and treatment of Wagner 3-5 diabetic foot wounds with limb salvation and terminating amputation as the end points. Methods  Based on the experience of healing 102 patients with Wagner 3-5 diabetic foot wounds by using MEBT in combination with surgical debridement, summarize the standards of clinical management and treatment of Wagner 3-5 diabetic foot wounds. Results  The clinical evidence from the healed 102 cases with Wagner 3-5 diabetic foot wounds has sufficiently demonstrated that significant therapeutic effects can be achieved when MEBT in combination with surgical debridement is applied to treat Wagner 3-5 diabetic foot wounds. Conclusion  MEBT in combination with surgical debridement can be the standard of managing and treating Wagner 3-5 diabetic foot wounds in clinic with its strength of limb salvation and terminating amputation. {Key words}  Moist Exposed Burn Therapy(MEBT); Surgical debridement; Wounds; Therapeutic effects; Standard

Biography:

Sara Atef, Colleage of Medicien, University of Sharjah, UAE

Abstract:

Overconsumption of meat is an escalating phenomenon in the UAE resulting in a wide range of unwanted outcomes, including the surge in the incidences of cardio-metabolic diseases and cancers over the past few decades.Our study thus focused on investigating the level of knowledge of Sharjah residents, comparing their consumption of meat to the current recommended daily intake, and outlining the factors leading to their unhealthy consumption.This cross-sectional study included 400 participants (50% were males) at the age of 18-50, and data was collected haphazardly by convenience using interview-based questionnaires and visual aids.Our results have demonstrated that Arabs and well-educated participants were more likely to consume processed meat, and thought grilling is the healthiest way of preparation. Also, most of the obese and overweight participants were knowledgeable yet, unable to maintain a healthy practice. Surprisingly, unmarried and knowledgeable participants were more likely to consume deep fried meat despite their awareness of its harms while married participants over-consumed grilled fish. Alarmingly, the working age group had an inadequate knowledge regarding meat since their educational level was below high school and had their friends as their primary source of information. In conclusion, our participants had an overall strong desire to over-consume fish and were unaware of their beef over-consumption. Arabic participants were under the misconception of grilling is the healthiest way of preparation yet, they over-consumed deep fried processed meat.Finally, this study offers a better understanding of the factors leading to unhealthy meat consumption, hence preventative interventions can be developed to decrease the prevalence of cancer and cardio-metabolic diseases in the UAE.

L Lateesh

Hand & Reconstructive Surgeon

Title: Surgical Outcome of Diabetic Foot Ulcers
Biography:

Dr L Lateesh, is a practicing Hand & Reconstructive Surgeon with over 15 years of experience having excelled in successfully performing complicated surgeries.
Special Interest: Podiatry 

Abstract:

Foot ulcers  are a serious complication of diabetes;  arising due to neuropathy, angiopathy ,arthropathy , tendinopathy leading  to altered  biomechanics of the foot  .The ulcers  will risk the patients with infections, amputations  and will have significant socioeconomic impact .The aim of the study is to setup  guidelines in the approach and treatment of diabetic  foot ulcers and  reduce the risk of amputations . An  analysis of  200 patients  from  2013 to 2017  who presented   to our podiatry  clinic  was grouped based on the location of the ulcers ,severity  of the ulcer , causative factors and co morbidities . The patients who underwent surgical offloading and reconstructive procedures were  followed up (average follow up 2.3Years)  and outcomes evaluated  based on the wound healing and complications . The study proves that appropriate surgical offloading has a significant role to play in reducing the incidence of amputations and complications in diabetic patients.

  • Challenges and Applications | Conventional Treatments

Session Introduction

Adeeb Al-Zoubi

Illinois College of Medicine in Peoria, USA.C.E.O. of Stem Cells of Arabia

Title: A New Combined Approach for Treatment of Type 1 Diabetes Mellitus By Immunomodulation and Beta Cell Regeneration
Speaker
Biography:

Adeeb Al-Zoubi is the CEO of Stem Cells Arabia which is located in Jordan and also he is a Clinical Assistant Professor of Regenerative Medicine at The University of Illinois, Greater chicago Area, USA.

Abstract:

Type 1 Diabetes Mellitus (T1DM) is a metabolic disorder defined by hyperglycemia resulting from a defect in insulin secretion by β cells in the pancreas. T1DM results as a consequence of chronic destruction of pancreatic β cells by the immune system, leading to insulin deficiency and subsequent pathologies including neuropathies, nephropathies, retinopathies and cardiovascular diseases. Although the definite cause of immune attack on β cells remains unknown, the mechanisms of the immune attack on β cells have been thoroughly studied, and were shown to comprise of a type 1 T Cell-mediated inflammatory immune response. Several clinical trials have been conducted to manage T1D using various approaches, including insulin pumps, pancreatic transplantation, pancreatic encapsulation, islet cell regeneration, and gene therapy. However, until today, these approaches have not led to the complete rescue of β cells nor to stop the development of T1DM.Recent advances in stem cell research have shown promising therapies for several chronic and untreatable conditions. Stem cells from various sources and types, including autologous bone marrow, cord umbilical blood, and embryonic stem cells, have been utilized in several clinical trials to treat T1DM, with varying outcomes. Our team has developed a two-armed approach; the first arm is aimed at stopping the immune attack on β cells, while the second arm aims at regenerating lost β cells in the pancreas. Results showed decreased immune attack, and β cells regeneration, and subsequent insulin production.
Objective: In this study, we aimed at ceasing the immune attack on β cells through immunomodulation, and regenerating β cells by transplantation of autologous, purified stem cells into the pancreatic arteries. Materials and Methods: This study consists of phase I and phase II. Phase I pilot study was from 2011-2015, and included four patients with confirmed T1DM, from 13-52 years old. Pre-operatively, patients had an average insulin intake of 50 units per day (20-80), average HbA1c of 9.0 (6.3-12.1), and Fasting Blood Sugar average of 350 (180-650); three patients had 0.00 C peptide, and the fourth (male, 32 years) had 0.23 C peptide. All patients were healthy, non-smokers, non alcoholics, except one (male, 32 years) with retrograde ejaculation. Patients received daily SC injections of 10ug/kg G-CSF (GeSysin, Filgrastim) for 5 days. On day 6, about 200 ml of peripheral blood mononuclear cells (PB-MNCs) were collected from peripheral blood. CD34+, CD133+, and CD271+ stem cells were isolated from PB-MNCs using the CliniMACS(R) System. The purified cell populations were injected into pancreatic arteries of patients using interventional radiology techniques. The remaining fraction of PB-MNCs that did not contain the above stem cell populations were co-cultured with adherent cord blood MSCs for 6 hours. After coculture, patient's autologous PB-MNCs (without MSCs) were injected back into the patient intravenously. Patients were then followed for up to 51 months (average 22 months), with measurements of C-peptide, insulin requirement, HbA1c, and FBS. Phase II study started on 2015 and is planned to go until 2018. Twenty-four patients were included in phase II study. Patients are currently enrolling in the study and are still being followed up. Results: All patients in phase I and phase II studies tolerated the procedures well. For phase I patients, there were no complications over the follow up period (14-51 months). Three out of four patients (75%) in the T1DM group completely stopped their insulin requirement at 6 month interval follow up. All 4 patients (100%) showed significant improvement in FBS (average 145, range 89-190). C peptide levels showed marked increase in all 4 patients (average 1.01, range 0.74-1.32). Similarly, 3 out of 4 patients showed significant improvement in measured HbA1c levels after 12 months (average 7.0, range 6.2-8.1). For phase II patients the study is still going on and it is too early to draw a meaningful conclusion; however, results are encouraging concerning HbA1c, C-peptide, Auto-antibodies, and Insulin intake. Conclusion: Our protocol represents hopeful and promising potential for the use of SCT in the treatment of T1DM patients. Future randomized controlled trials are needed to support the results of our pilot study.