Global development of Diabetes and potential cure of patients…..

I believe that stem cell treatment will become mainstream still in this decade and stem cell tourism is a creation of advanced, experimental but not fully developed science. This fast growing medical application with stem cells only shows that there is each time more a high awareness by patients of a huge gap between present medical treatment of symptoms and potential cure as an unmet medical need provided by present mainstream medicine.

Unfortunately, often  those institutes who are able to  serve as a new platform for medical treatment are not funded enough to follow established clinical trial  policies which could in turn increase the credibility of stem cell treatment and support its advancement as mainstream alternative.

In recent months,  we could learn that there had been further breakthroughs in stem cell treatment of diabetes as publicised in various medical journals but also via YouTube as shown below.

The question many people have, “Will it, this time, go ahead and result into alternative treatment” of existing mainstream treatment of insulin injections or will it just be ignored like the published research of Weissman, in mid  90ties, a professor of pathology and development biology at Stanford University.  Already in that time he demonstrated the ability to fully cure type 1 diabetes (T1D) in mice using stem cells. But even thought the experiments avoided political controversy by using adult stem cells, which do not come from embryos, Weissmann ran into one roadblock after another as pharmaceutical companies refused to sponsor his suggested clinical trials. The therapy went nowhere!

What however is Diabetes which is affecting millions of people globally. In this YouTube video below we will explain all about Diabetes:

Now as we know more about diabetes lets look into another attempt to cure diabetes. Dr. Richard Burt of Northwestern University’s Feinberg School of Medicine in Chicago and colleagues first reported on the short-term success of the procedure, known as autologous non-myeloablative hematopoietic stem-cell transplantation in 2007, but have since looked at how long it persisted.

On April 14, 2009 Reuters reported that People with type 1 diabetes who got those stem cell transplants were able to go as long as four years without needing insulin treatments.

They said the process, which involves injecting people with stem cells made from their bone marrow cells, appears to have a lasting effect. The study involved patients with Type 1 diabetes, formerly called juvenile diabetes, which occurs when the immune system goes haywire and starts attacking itself, destroying insulin-producing cells in the pancreas needed to control blood sugar.

These patients typically need daily insulin therapy to control their diabetes. According to further details mentioned in the  Journal of the American Medical Association (April 14, 2009), it was explained that  20 of 23 patients “became insulin free — 12 continuously and eight transiently — for periods as long as four years.” The transient group of eight had to restart insulin at reduced levels.

It appears more and more to be certain that stem cells can cure and treatment using stem cells from bone marrow, umbilical cord blood and adipose tissue are as “experimental therapy” already available outside of mainstream medicine.

An even more exciting data emerged in January 2012 in Toronto, The Star reported that according to a study from the University of Illinois has found that treating a Type 1 diabetic’s T-Cells with human cord blood stem cells may be a possible cure – helping restart the pancreatic function and insulin production.

According to the study and its author Dr. Yong Zhao, an assistant professor of medicine at the University of Illinois, the study is a “significant breakthrough” in the quest for new treatments. The study, published in BMC Medicine, an open-access journal found that the stem cells from the cord blood “re-educated” the patients’ T-cells.

Zhao and his team recruited 15 patients at the General Hospital of Jinan Military Command in Jinan, Shandong, China. Twelve participants had the treatment while three others made up a control group. All of them had Type 1 diabetes, which is considered an autoimmune problem because the T-cells attack cells inside the pancreatic islet.

In the study,  the 12 participants had their T-cells – which were separated from their blood –pumped into a device Zhao calls a “stem cell educator.” There the T-cells were exposed to cord blood stem cells for three hours, Zhao explained in an interview with the Star.

The stem cells “re-educated the T-cells”, said Zhao, who specializes in endocrinology, stem cells and immunology. “They wake them up and correct their function. The stems cells are like a teacher. The T-cells are like a bad student.” Then the T-cells were pumped back into the participants’ blood. The patients were then checked four times after the treatment at four weeks, then 12, 24 and 40 weeks later.

The results were astounding, said Zhao. “The patients couldn’t make any insulin before the treatment. But after the treatment they began to make their own insulin.” Their autoimmune response was reversed, the researcher explained. One year later, the patients who got the treatment continue to manufacture some of their own insulin and eight have reduced their insulin shots by about 38 per cent. Zhao hypothesizes that if the patients had more than one treatment, the results would be even more dramatic.

Prof. Zhao plans to do another study with patients having multiple treatments to see if it’s possible to totally reverse the loss of insulin production function. He is also pursuing some clinical trials on Type 2 diabetes patients. With Type 2 diabetes,  the pancreatic islet can make insulin, but the liver is resistant to it and not picking it up, Zhao explained. This kind of insulin resistance is associated with immune dysfunction, Zhao said. “You can use the Stem Cell Educator therapy to crack their immune dysfunction and overcome the insulin resistance.”

Zhao is currently conducting a trial on 25 patients. The first results are “exciting,” but the study has not yet concluded. “This will open a new research field for both Type 1 and Type 2 diabetes,” Zhao said.

In a business review and research on Jinan Tianhe Stem Cell Biotechnology Co., Ltd., ARISTOLOFT found, that they are located in Jinan High tech Bioindustry Park District, China and have  developed a devise called the  “Stem Cell Educator Therapy” focusing on diabetes treatment. According to information published, the clinical data established, it provides a powerful evidence that Stem Cell Educator therapy can balance the immune system and lead to regeneration of islets beta cells and improve of metabolic control in long-standing diabetic subjects. The principles of this treatment may also be beneficial in other autoimmune – related diseases.

General Information about the Stem Cell Educator Therapy.

Jinan Tianhe Stem Cell Biotechnology Co., Ltd, China recently developed a novel therapy designated Stem Cell Educator therapy, based on our results in non-obese diabetic (NOD) mice and other pre-clinical evidence that CB-SCs can control autoimmune responses by altering Tregs and human islet  cell-specific T cell clones. Briefly, a 16-gauge IV needle is placed in the median cubital vein to isolate lymphocytes from the patient’s blood by using a Blood Cell Separator. The collected lymphocytes are transferred into the device for exposure to CB-SCs, and other blood components are automatically returned to the patient. The Stem Cell Educator functions as part of a closed-loop system that circulates a patient’s blood through a blood cell separator, briefly co-cultures the patient’s lymphocytes with CB-SCs    in vitro, and returns the educated lymphocytes to the patient’s circulation. CB-SCs tightly attached to interior surfaces in the device, and only the CB-SC-educated autologous lymphocytes are returned to the subjects. The Stem Cell Educator therapy requires only two venipunctures with minimal pain and does not introduce stem cells or reagents into patients in comparison with other stem cell-based therapies (e.g., mesenchymal stem cells [MSCs] and hematopoietic stem cells [HSCs]). Additionally, CB-SCs display very low immunogenicity, eliminating the need for human leukocyte antigen (HLA) matching prior to treatment. Thus, these advantages of Stem Cell Educator therapy may provide CB-SC-mediated immune modulation therapy while mitigating the safety and ethical concerns associated with other stem cell-based approaches and conventional immune therapies.

Safety of Stem Cell Educator therapy 

Published data and unpublished data of Tianhe Stem Cell Biotechnology demonstrated that Stem Cell Educator therapy was well tolerated in all participants (n = 150) with minimal pain from two venipunctures. Most patients experienced mild discomfort during venipuncture and some soreness of the arm during aphaeresis, but discomfort and soreness resolved quickly following the conclusion of the procedure. There were no participants experienced any significant adverse events during the course of treatment and no adverse events during one year follow-up studies.

In comparison with the application of MSCs, autologous bone marrow-derived MSC has been limited for clinical applications due to the painful operations and potential infections in the procedure for harvesting bone marrow. To this end, placenta or umbilical cords are easy to access and represent valuable sources for the provision of allogeneic MSCs. However, patients usually showed medium or high fever following transplant of allogeneic MSCs through interventional therapy such as intravenous delivery or direct infusion into pancreatic islets via transfemoral cannulation under angiography.

Efficacy of Stem Cell Educator therapy in Type 1 Diabetes (T1D)

Findings from Tianhe Stem Cell Biotechnology clinical trials provide powerful evidence that a single treatment with the Stem Cell Educator provides lasting reversal of autoimmunity that allows regeneration of islet β cells and improvement of metabolic control in individuals with long-standing T1D. In an open-label, phase1/phase 2 study, 15 patients with T1D received one treatment with the Stem Cell Educator.  Their median age was 29 years (range, 15 to 41), and median diabetic history was 8 years (range, 1 to 21).

Stem Cell Educator therapy can markedly improve C-peptide levels, reduce the median glycated hemoglobin A1C (HbA1C) values, and decrease the median daily dose of insulin in patients with some residual β cell function (n = 6) and patients with no residual pancreatic islet β cell function (n = 6). Treatment also produced an increase in basal and glucose-stimulated C-peptide levels through 40 weeks.

However, participants in the Control Group (n = 3) did not exhibit significant change at any follow-up. Notably, a single treatment could improve islet β function that lasts a year.  Individuals who received Stem Cell Educator therapy exhibited increased expression of costimulating molecules (specifically, CD28 and ICOS), increases in the number of CD4+CD25+Foxp3+ Tregs, and restoration of Th1/Th2/Th3 cytokine balance. Thus, findings from these trials indicate that CB-SC-mediated reversal of autoimmunity results from modulation of the immune response in multiple immune cell types, thereby meeting the expectation that successful therapies will likely address different arms of the autoimmune response and balance the immune system through the systemic and local modulations.

Immune dysfunction of T1D is complicated not only in localizing in pancreatic islets, but also appearing outside of pancreata. There are different compartments of the immune system (e.g., T cells, Tregs, B cells, DCs, Mo/Mϕ, iNKT) contributing to the autoimmune responses. Therefore, the comprehensive immune modulations via local and systematic approaches are needed to simultaneously address these multiple dysfunctions in clinics. Stem Cell Educator therapy functions as “an artificial Thymus” that circulates a patient’s blood through a blood cell separator, briefly co-cultures the patient’s lymphocytes with CB-SCs in vitro, induces the immune tolerance through the action of autoimmune regulator (Aire), returns the educated lymphocytes to the patient’s circulation and restores the immune balance and homeostasis. During this procedure, both peripheral and pancreatic infiltrated lymphocytes can be isolated by a blood cell separator and treated by CB-SCs. This treatment leads to the global immune modulations and immune balance as demonstrated by Tianhe Stem Cell Biotechnology clinical data and animal studies.

What I like especially about this latest “breakthrough information”  is the structured approach to develop stem cell therapy with evidence based clinical trials to become mainstream treatment.

Currently, Tianhe Stem Cell Biotechnology  has 4 ongoing Clinical Trials. For more information on these trials, please use the following links and visit ClinicalTrial.gov. If you are interested in joining one of these trials, please contact Tianhe Stem Cell Biotechnology  at: [email protected] , who happily will send you more detailed information.

    • International multi-center Phase II Clinical trial: Stem Cell Educator Therapy in Type 1 Diabetes (ClinicalTrial.gov Number: NCT01350219).
    • Phase I/II Clinical trial: Stem Cell Educator Therapy in Type 2 Diabetes (ClinicalTrial.gov Number: NCT01415726).
    • Phase I/II Clinical trial: Stem Cell Educator Therapy in Alopecia Areata (ClinicalTrial.gov Number: NCT01673789).
    • Phase I/II Clinical trial: Stem Cell Educator Therapy in Children with Type 1 Diabetes. (To be started soon)

From international statistics, including WHO reports, we can assume that about 12 to 15 % of people being affected by diabetes have type 1 diabetes, whereas the remaining group has mainly type 2 diabetes. According to WHO reports about 171 Mio people had been affected by diabetes  in 2000, and the number may increase to 366 Mio people by the year 2030. The Countries with the strongest prevalence of diabetes are shown in the graph below:

A study commissioned by healthcare company Novo Nordisk has reported that the cost of diabetes and pre-diabetes to the U.S. economy in 2007 was $218 billion. The    study,  conducted by The Lewin Group, projected that by 2034, the two conditions will cost the U.S. economy $336 billion per year.

The study looked at not only direct medical costs, such as medicines, monitoring and dosing equipment, and visits to doctors, clinics, and hospitals, but also indirect costs created by absenteeism and losses in productivity related to diabetes. It estimated direct costs at $153 billion, while indirect costs were $65 billion.

The $218 billion figure, said a spokesman for The Lewin Group, amounts to a $700 “hidden tax” on every person living in the United States. The study further broke down diabetes and pre-diabetes costs in 2007 by categories of the disease:

      • Diagnosed type 2 diabetes:                $174.4 billion
      • Undiagnosed type 2 diabetes:           $  18.0 billion
      • Type 1 diabetes:                                  $  14.9 billion
      • Pre-diabetes:                                       $  25.0 billion

One telling statistic was the breakdown in cost-per-year per patient:

      • A person with type 1 diabetes:          $  15,000
      • A person with type 2 diabetes:          $  10,000
      • A person with pre-diabetes:               $       443

This U.S. Data in respect of cost per person appears to be considerably higher than in Europe, but as no unique databank for diabetes in Europe exists the data received in the European survey may not be complete.

The objective of the European research conducted in 2011 was to identify and compare the diabetes burden of disease, costs (direct and indirect) and diabetes outcomes, focusing on complications across France, Germany, Italy, Spain, and the UK (EU5). This in turn may increase the understanding of the state of diabetes management in EU5 from which to make informed policy recommendations.

A survey was designed and sent to health economists in the EU5 countries. In turn, key diabetes clinicians, decision makers and health officials were interviewed in order to answer the survey. In addition, secondary data were collected from PubMed, diabetes association publications and health government publications and websites, including national statistics.

Diabetes prevalence ranges between 4.8% (Italy) to 8.9% (Germany), and has increased over time. Although none of the EU5 countries record diabetes costs directly, including complications, estimates for 2010 suggest that the total direct annual cost ranges from €5.45bn (Spain) to €43.2bn (Germany); across EU5 the total direct cost of diabetes was €90 billion.

Per patient direct costs are more comparable across countries, with some variation ranging from €1,708 in Spain to €5,899 in Germany in 2010, suggesting a key driver behind total diabetes costs is prevalence. Inpatient care represents the greatest component of direct costs (33-49%), followed by outpatient (18-36%) and pharmaceuticals (diabetes plus non-diabetes) (20-32%). Expenditure on insulin and oral anti-diabetic medicines ranges between 6.2% and 10.5% of total direct cost.

A significant majority of inpatient direct costs account for treatment of diabetes related complications, affecting approximately 18.3 million diabetic patients each year across the five study countries. Indirect costs, relate to reduced productivity, absenteeism, early retirement, social benefits and carer costs; these costs are significant and, having quantified part of these costs for the first time in Europe (relating to absenteeism, early retirement and social benefits), it appears that they stand at €98.4 billion and can exceed direct costs by at least a factor of 2- or even 3- to-1 depending on the country.

All studies concluded that the best public health policy would be to focus on high-risk patients who have not yet acquired the disease and encourage them to adopt the lifestyle changes that reduce the risk of developing diabetes. In one study, the Diabetes Prevention Program, those changes, which include moderate weight loss and increased physical activity, reduced the risk of diabetes by as much as 58 percent.

Well seeing this data and cost structure we can easily understand that most governments are looking into the their health care cost development and try to cope with the ever rising costs of health care, mainly by shifting costs directly or indirectly back to individuals!

We believe that stem cell treatment is a valuable alternative even though the initial cost – at this moment – appears to be high, but the follow up costs of permanent treatment is dramatically reduced if patients become as the study shows four or more years free of mainstream treatment and avoids potentially reduced productivity, absenteeism, early retirement, social benefits and carer costs exceeding significantly the cost for actual treatment of diabetes.

We like to encourage with this review clinics and stem cell banks to join forces to establish and register more clinical trials to develop further the much needed evidence for regulators that stem cell therapy is not anymore only experimental but a valuable alternative in medical treatment.

Source & related Articles:

http://www.tianhecell.com/Educator_Therapy.html
http://www.tianhecell.com/Clinical_Trials.html
PRNewswire press release  –  Diabetes Health by Patrick Totty  –  Feb 3, 2010
Toronto  –  Stem cell treatment may reverse Type 1 diabetes: researcher – thestar.com
http://www.biomedcentral.com/1741-7015/10/3
http://www.who.int/diabetes/facts/world_figures/en/index3.html
http://www2.lse.ac.uk/LSEHealthAndSocialCare/research/LSEHealth/MTRG/ResearchReportOnDiabetes.aspx
http://www.medicalnewstoday.com/articles/252759.php
http://www.time.com/time/health/article/0,8599,1891122,00.html
http://www.columbiaspectator.com/2009/01/23/scientist-revives-research

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