This trial is evaluating whether Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Higher Dose will improve 1 primary outcome and 1 secondary outcome in patients with Diabetes Mellitus, Type 2. Measurement will happen over the course of pretreatment, month 12.
This trial requires 30 total participants across 2 different treatment groups
This trial involves 2 different treatments. Autologous Adipose-derived Mesenchymal Stem/stromal Cells (MSC) Higher Dose is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.
Type 2 diabetes is marked by complications of long duration. As many as 40% of patients may be asymptomatic for 20 or more years, thus delaying the diagnosis and compromising treatment options. The absence of clinically obvious symptoms is one of the key components of its diagnosis.
The treatment of diabetes tends to be based on the current paradigm and has a long history. The treatment for diabetes typically includes dietary modifications, lifestyle modification, lifestyle changes such as exercise, and prescription medications. Some specific medications used for diabetes treatment include glyburide and metformin. Other medications, such as acarbose, are used for specific patient needs. There are no medicines that can cure diabetes.
The prevalence rates of T2DM in different Asian ethnicities are varying, but were generally similar in a group of Asian patients from the Netherlands. The T2DM is more frequent in the male sex. Although T2DM tends to affect individuals younger than 40 years, the age at the onset of the disease in this study cohort was not significantly different between male and female. However, diabetic patients younger than 40 tend to receive poorer glycemic control by their diabetic physicians than those aged 40 years or older. Diabetic patients of either sex should gain special attention to early diabetic screening and early diagnosis of diabetic micro- and macrovascular complications.
About 14 million people have been diagnosed with DM type 2 at some point in their lives or are pre-diabetic in the USA annually. The age-adjusted prevalence of diagnosed diabetes is 16% among whites, 3% among blacks and 20% among Hispanics. DM type 2 prevalence varies by sex, ethnicity and socioeconomic factors. The disparity of DM type 2 between sexes and ethnic groups may reflect different environmental and genetic exposures.
Diabetic patients who are carefully managed with close blood pressure monitoring and with an intensive glycemic control regimen can live long healthy lives, and diabetic patients can be cured, if proper management is implemented. Such a comprehensive strategy is the only proven cure for long-standing, well-controlled T2DM.
Diabetes mellitus is a disease of high prevalence and many ramifications. The consequences can be seen in all aspects of the life. The health related consequences of untreated diabetes can be debilitating. Diabetes, as the disease, affects over 20 million people in the U.S. alone and is still on the rise.
Findings from a recent study supports the use of a high dose of autologous adipose derived MSC treatment in combination with any other treatments for wound healing.
The present data indicate that higher dose autologous MSC are more effective in improvement of glycometabolic status, adiposity and insulin sensitivity after high fat/high fructose diet-induced metabolic disturbances in Wistar normoglucidaemic rats. The present data suggest that the higher dose of autologous MSC might be considered as a good therapy option for non-insulin dependent diabetes mellitus.
Diabetes-prone families show a strong degree of clustering at the grandparent and great-grandparent level, although the underlying genetic relationship between diabetes-prone persons and their relatives is not well understood.
Approximately 11% of respondents reported the average age at DM2 onset. Results from a recent paper show that diabetes is a rising concern for both children and adults of every age.
A systematic approach to the identification of patients should be employed. This approach should be based at least on age and DM2 risk factors. Additional risk factors can be taken into account, for example diabetes autoantibodies. It is the responsibility of the clinician to define and tailor the therapeutic choices for each individual.
Type 2 diabetes mellitus is a disease with different causes and a variable pathogenesis, and is characterized by several risk factors, but not a single one (e.g. diabetes is not caused by an increase in a single blood sugar level). Although our knowledge has increased over the past decades, it is far from being completely understood, and the number of available therapeutic options are still rather limited.