Diabetes Stem Cell Studies

Diabetes is a defect in the body’s ability to convert glucose (sugar) to energy. Glucose is the main source of fuel for our body. When food is digested it is changed into fats, protein, or carbohydrates. Foods that affect blood sugars are called carbohydrates. Carbohydrates, when digested, change to glucose. Examples of some carbohydrates are: bread, rice, pasta, potatoes, corn, fruit, and milk products. Individuals with Diabetes should eat carbohydrates but must do so in moderation. Glucose is then transferred to the blood and is used by the cells for energy. In order for glucose to be transferred from the blood into the cells, the hormone - insulin is needed. Insulin is produced by the beta cells in the pancreas (the organ that produces insulin).

In individuals with Diabetes, this process is impaired. Diabetes develops when the pancreas fails to produce sufficient quantities of insulin – Type 1 Diabetes or the insulin produced is defective and cannot move glucose into the cells – Type 2 Diabetes. Either insulin is not produced in sufficient quantities or the insulin produced is defective and cannot move the glucose into the cells.

The diagnosis of Diabetes is made by a simple blood test measuring your blood glucose level. Usually these tests are repeated on a subsequent day to confirm the diagnosis.

Both forms and all stages of Diabetes are serious, with many possible complications, including eye, heart, kidney, and nerve damage.

Type 1 Diabetes is an auto-immune disease where the body's immune system attacks the insulin-producing cells of the pancreas. People with type 1 Diabetes cannot produce insulin and require lifelong insulin injections for survival. The disease can occur at any age, although it mostly occurs in children and young adults. Type 1 Diabetes is sometimes referred to as 'juvenile onset Diabetes' or 'insulin dependent Diabetes'.

Type 2 Diabetes is associated with hereditary factors and lifestyle risk factors including poor diet, insufficient physical activity and being overweight or obese. People with type 2 Diabetes may be able to manage their condition through lifestyle changes; however, Diabetes medications or insulin injections may also be required to control blood sugar levels. Type 2 Diabetes occurs mostly in people aged over 40 years old; however, the disease is also becoming increasingly prevalent in younger age groups.

Type 1 Diabetes Symptoms:

• Excessive thirst
• Frequent urination including bedwetting
• Excessive hunger
• Unexplained weakness and fatigue
• Weight loss
• Blurred vision
• Vaginal discharge or itch in young girls
• Nausea and vomiting.

Type 2 Diabetes Symptoms:

• Blurred vision
• Tiredness
• Urinating more frequently
• Feeling thirsty all the time
• Numbness and tingling in the feet or legs
• Recurrent infections

Stem cells are unprogrammed cells in the human body that can be described as "shape shifters." These cells have the ability to change or “differentiate” into other types of cells. Stem cells are at the center of a new field of science called regenerative medicine. Because stem cells can become bone, muscle, cartilage and other specialized types of cells, they have the potential to treat many diseases, including Parkinson's, Alzheimer's, Diabetes and more.

StemGenex offers stem cell therapy using Adult stem cells only. There are four known types of stem cells:

• Adult Stem Cells - derived from the adult human body
  The use of adult stem cells in research and therapy is not as controversial as the use of embryonic stem cells, because the production of adult stem cells does not require the destruction of an embryo. Additionally, in instances where adult stem cells are obtained from the intended recipient, the risk of rejection is essentially non-existent. Consequently, more US government funding is being provided for adult stem cell research. This is why StemGenex offers stem cell studies using Adult stem cells only.
• Embryonic Stem Cells - derived from embryos
  These cells require specific signals to differentiate to the desired cell type. If they are simply injected directly, they will differentiate into many different types of cells, resulting in a tumor derived from this abnormal pluripotent cell development (a teratoma). The directed differentiation of ES cells and avoidance of transplant rejection are just two of the hurdles that ES cell researchers still face. StemGenex does not use embryonic stem cells.
• Fetal Stem Cells - derived from aborted fetuses
  Have developed further than embryonic stem cells and are a little more specialized – their options are slightly more limited. However, they can still produce most types of cell in the body. StemGenex does not use fetal stem cells.
• Induced Pluripotent Stem Cells (iPSCs) - from some parts of the human body
  These stem cells are engineered from older, fully specialized cells – for example, skin cells, which are limited naturally to being only skin cells. Scientists encourage these limited cells to act like embryonic stem cells again, with the ability to become any type of human cell. This is a complex technique that has only recently been developed and is the subject of much ongoing research. StemGenex does not use induced pluripotent stem cells.

Stem cell therapy is an intervention strategy that introduces new adult stem cells into damaged tissue in order to treat disease or injury. Many medical researchers believe that stem cell treatments have the potential to change the face of human disease and alleviate suffering. The ability of stem cells to self-renew and give rise to subsequent generations with variable degrees of differentiation capacities, offers significant potential for generation of tissues that can potentially replace diseases and damaged areas in the body, with minimal risk of rejection and side effects.

StemGenex is currently studying adipose stem cell therapy as a new alternative treatment to help manage the complications of Diabetes. The stem cells harvested from a patient may have the potential to replace countless cells of the body, insulin producing cells included. The undifferentiated cells may heal the body by replacing ones plagued with disease by regenerating new cells.

Current research in adult stem cell therapy is hopeful for turning Stem Cells into Insulin-Producing Cells. A breakthrough in regenerative medicine shines a light of hope on those battling this disease. Scientists are also looking at ways to circumvent the complex natural developmental process by converting mature cells, like liver or pancreatic exocrine cells, into insulin-producing cells using stem cells.

Improvements have been seen in the following symptoms after treatment:

• Better glycemic control
• Significant decreases in insulin requirement
• Higher energy levels

StemGenex is studying potential ways to directly target the conditions and complications themselves. These studies consist of multiple ways to deliver the highest amount of activated stem cells to the areas patients need them most. When stem cells are studied through StemGenex, as potential therapy for Diabetes, the stem cells are administered through IV. Intravenous administration is delivered directly into the vein.

StemGenex is currently studying the effectiveness of Mesenchymal Stem Cell Therapy on patients with both Type I and Type II Diabetes.

Yes. Scientists around the world believe there is enough evidence to suggest that stem cells hold real potential as a therapy for Diabetes. This evidence comes from a multitude of early clinical studies. They believe that it is now time for a concerted effort in stem cell research and an international effort to support clinical studies of stem cells for Diabetes.

No. There are currently no FDA approved stem cell therapies for Diabetes. All stem cell therapies for Diabetes are currently ‘unproven’, ‘experimental’ therapies. This means that the FDA does not know whether stem cells are effective for people with Diabetes. The only way to determine the effectiveness of stem cell therapy is through the type of clinical studies and trials which are currently being conducted in the US.

One of the goals of StemGenex, through our stem cell studies, is to understand what a particular stem cell therapy might be able to achieve. For example, does it have the potential for slowing the disease's progression, replacing damaged cells and memories, or both? With this goal in mind, StemGenex continues to study these diseases and the full effect of stem cell therapy on each disease. Anecdotally, these results have been overwhelmingly positive but there is more that needs to be done to determine the exact effectiveness of these therapies.

After stem cells have been administered into someone’s body they have to make their way to the correct place (e.g. area of damage) and then have their desired effect. This process takes time and although it is difficult to predict exactly how long, it is likely that it will take several weeks or months on average to see the full desired effect.

Yes, a stem cell therapy may be repeated. Current studies indicate the strong possibility of a cumulative effect from multiple stem cell therapies a patient received for their condition. Long-term studies will attempt to better understand this in detail.

We don’t know yet. This will not be studied in early clinical trials, as this would make it very difficult to measure the true effects of the stem cell therapy. However, a combination therapy may be effective for Diabetes and is likely to be studied in the future.