GIOSTAR Diabetes Type-2 Pre IND Clinical Trial – US FDA
Diabetes is increasing at a rampant rate all around the globe which is affecting developed countries more severely than developing ones. In the USA itself, almost 10% of the population has been living with diagnosed or undiagnosed diabetes. Since such a big section of the population is affected by diabetes, the cost of taking care of the individuals is also increasing. According to an assessment by the Diabetes Association of America, the cost of taking care of diabetics had added up to $327 billion in 2017. Out of which $237 billion was direct medical cost and remaining because of reduced productivity. Type II diabetes, which is caused by loss of insulin sensitivity is seen more commonly in the older population. However, with increasing easy and unimpeded availability of high-calorie foods and decreasing factors necessitating physical work, it is showing up in the younger population significantly. About 193,000 Americans under the age of 20 years are estimated to have diagnosed diabetes.
Though a number of medications are already in clinical use, none of them grant a long-term cure and all of them have some or other undesired side effects. To circumvent all these concerns another alternative way of handling the problem was needed for a long time. Discovery of stem cells and related extensive research has offered a ray of hope to manage the problem efficiently with a sound possibility of a permanent cure. Stem cells, depending on the source of their origin or due to post-isolation manipulations, are classified as embryonic or adult or induced.
Keeping different facts in a view, GIOSTAR Chairman, Dr. Anand Srivastava, started his research to differentiate stem cells into the insulin-secreting cells, which may be used for therapeutic purposes. Therefore, GIOSTAR is in the process of USA-FDA approval for a clinical trial to develop a stem cell-based treatment for Diabetes type 2. DR. ANAND SRIVASTAVA, M.S., PH.D. – CHAIRMAN, CO-FOUNDER, AND CHIEF SCIENTIFIC OFFICER
Mesenchymal stem cells (MSCs), isolated from visceral fatty tissues of adults, are known to promote the regeneration of pancreatic islet beta cells, protect them from apoptosis, and ameliorate insulin resistance in peripheral tissues by providing a supportive niche microenvironment driven by the secretion of paracrine factors or the deposition of the extracellular matrix. In general, implantation of MSCs can alleviate T2D by a number of mechanisms that include reducing systemic oxidative stress, a factor responsible for causing the death of insulin-producing cells and at the same time, contributing to insulin resistance too. Also, these cells, after being exposed to pro-inflammatory cytokines like IFN-g, become a source of anti-inflammatory cytokines. These cells, if implanted directly in the pancreas, due to their multipotential ability to differentiate in diverse types of cells of their immediate vicinity, can produce new insulin-producing cells. To promote the chances of their differentiation into insulin-producing cells, their preprogramming has been tried. Also, intravenous infusion of stem cells has been shown to regenerate beta cells of pancreatic islets and promote insulin sensitivity by decreasing systemic inflammation, the root cause of insulin resistance.
Encouraging findings in cases of diabetes treatments with stem cell therapies have led many clinicians to try implantation or infusion or both in the clinics. In more than 150 trials at different stages listed on NIH’s webpage implantation or infusion of MSCs have shown promising results up to several months of follow up. A couple of clinical parameters like H1Ac and needed insulin to manage blood glucose decreased after the MSC-treatments, which was also accompanied by increased insulin sensitivity.
Stem cell therapy may have some undesirable effects, though the incidences are few and far between. Even those undesired effects like mild to moderate fever or nausea or headache, which happen after stem cell transplantation, are very mild and are easily manageable.
In conclusion, GIOSTAR Chairman Dr. Anand Srivastava stated that stem cell therapy may offer a long-lasting therapeutic alternative for treating T2D. At the same time, it has to be kept in mind that it is not a permanent cure yet. T2D is a metabolic syndrome manifesting after a long duration of an unhealthy lifestyle that needs to be addressed in order to lead a healthy life. Compared to all other available therapies, stem cell therapy may offer a lot longer drug-free periods for individuals to develop a healthy lifestyle in order to fend off the re-occurrence of the disease.
Deven’s Networking Interest: Hospitals and clinics interested in partnering for clinical trials.
Source : https://www.theintroducermagazine.com/league-members-innovating-for-diabetics/
The massive fervor around blockchain technology has quelled a bit due to a number of challenges facing the emerging industry ranging from speed and cost to interoperability and perception. The fact that many, more vocal blockchain devotees are working a bit more quietly through such issues now gives the chance for others to start to come to surface. Many innovators are finding new ways to apply blockchain technology and in a manner beyond solely that of the financial and advertising realms, for example. In fact when coupled with a philanthropic intent, blockchain seems now poised to reach even greater heights because the work is fused with true social benefit.
Indeed a GIOSTAR Labs, a company which is focused on stem cell-based technologies and is a subsidiary of a company called Giostar, recently joined forces with the Association of Professional Ball Players of America (APBPA) to launch what the company is calling the non-profit Stem Cells For All initiative. The intent is to provide, for the first time ever, stem cell treatment to athletes, families, fans at deep discounts, and GIOSTAR will will be one of the first to apply blockchain in a new way to ensure successful outcome.
This work is the brainchild of GIOSTAR Chairman and Co-founder Dr. Anand Srivastava. Who, along with his fellow co-founder and team realized the fact that many baseball players face injuries which require not only extensive surgery that is demanding on the body but that which can also causes severe financial stress as well. So they decided to create a pilot initiative where members of the APBPA can now receive free or deeply discounted therapies at GIOSTAR’s Chicago location, the office dedicated solely to providing stem cell services to the underserved.
But it is blockchain technology which will up the ante in the treatment process. Explains GIOSTAR Co-Founder Siddarth Bhavsar, “Federated permissioned blockchain based on HIPAA compatible nodes allows us to build trust via data integrity and permissioned collaboration from the ground up.” He continues, “Since personalized precision medicine like stem cells entails an additional level of data complexity, thus an AI and NLP algorithms layer will bring greater structure and extract meaning from the data to improve accuracy.”
So far, six pitchers have undergone therapy with additional procedures underway thanks to generous donations and successful fundraisers. These athletes include Arnie Costell of the Houston Astros and the Detroit Tigers and Mike Rossiter of the Oakland Athletics and Milwaukee Brewers.
Now GIOSTAR says that dozens of subsidized therapies are underway as a result of their agreement with the Association. The lab will be working to release cutting edge technology in stem cell application with blockchain integration over the next 12 months enabling enabling them to decrease therapy costs, disrupt the pricing model of the industry and allow them to treat more people than the industry ever has.
GIOSTAR says that it intends to engage the Food and Drug Administration (FDA) via the Regenerative Medicine Advanced Therapy (RMAT) process to ensure proper safety protocols and efficacy and plans to commercialize stem cell therapy as a service by launching a suite of shippable, stem cell-derived growth factor products.
Regenerative medicine has been called the next evolution of medical treatments by the U.S. Department of Health and Human Services, however the field is not without controversy and confusion about what is and is not possible in terms of cures within this emerging space. Many professionals in the arena say that the results are simply not as straightforward as purported. In fact, Consumer Reports printed an extensive investigative piece not long ago on the industry, though much of this pushback was tied to high costs for the services.
Bhavsar is undaunted and fiercely driven precisely because of the cost-disruption model. He explains, “Just as open-source software model drove exponential innovation in the technology sector, we believe open-source clinical research model powered by blockchain and AI will improve efficiency, accuracy, reduce costs and accelerate innovation in healthcare.”
Though based in San-Diego, GIOSTAR now has similar plans for such initiatives in India, China and Mexico. Dr. Srivastava already has deep ties to India through his previous invitation from the country’s Ministry of Human Resources Development to train scientists in the region in the field of advanced stem cell science.
Says Bhavsar, “Each day we are moving one step closer to fulfilling our mission to make this amazing science accessible and affordable to the masses thanks to emerging technology and major dedication.”
“The intent is to provide, for the first time ever, stem cell treatment to athletes, families, fans at deep discounts, and GIOSTAR will be one of the first to apply blockchain in a new way to ensure successful outcome.”
Chairman and Co-Founder of GIOSTAR Dr. Anand Srivastava was invited by Ministry of Human Resources Development, Government of India to train Indian scientists in the field of advanced stem cell science.
The program was conducted by Department of Life Sciences, University of Calicut, Kerala under name of GIAN. He trained and shared his experience of stem cells research with scientist/researchers for ten days.