Dr. Yong Zhao presented Stem Cell Educator therapy at the 15th World Congress on Targeting Mitochondria in Berlin

Paramus, New Jersey (Nov.11, 2024) - The 15th World Mitochondria Society (WMS) Annual Meeting on Targeting Mitochondria, was held on October 29-31, 2024 in Berlin, Germany. Dr. Yong Zhao was invited by Dr. Marvin Edeas (Professor of Medicine at the University of Paris, Founder of WMS) to give a presentation as a major speaker at this Congress, titled “Stem Cell Educator Therapy: A New Era in Mitochondrial Transfer and Regeneration”.

Over the last 14 years, Throne Biotechnologies (Throne) has developed a unique and novel procedure designated the Stem Cell Educator (SCE) therapy. International multi-center clinical studies have demonstrated its clinical efficacy and safety of SCE therapy that can fundamentally reverse type 1 diabetes (T1D), alopecia areata (AA) and other autoimmune/inflammatory diseases or aging-associated neurodegenerative diseases through the immune education of SCE therapy at the root causes, which are the mitochondrial dysfunctions at the local or systematic levels. Dr. Zhao updated the current clinical and research progresses of Stem Cell Educator therapy for the treatment of T1D and other autoimmune diseases. SCE therapy holds great promise to revolutionize the treatment of T1D and eliminate the need for lifelong insulin therapy in recent onset subjects, without the safety and ethical concerns associated with conventional immune and stem cell-based approaches. SCE therapy is the leading technology in immunotherapy and mitochondrial transfer to date to safely and efficiently repair and correct the mitochondrial dysfunctions in multiple human diseases caused by the autoimmunity, chronic inflammation and/or aging.

Photo: Dr. Yong Zhao (middle) was together with Dr. Volkmar Weissig (right, Midwestern University, USA, President of the World Mitochondria Society) and Dr. Marvin Edeas (left, Institut Cochin, INSERM U1016, Université de Paris, France, Founder of the World Mitochondria Society).

New Publication: Increase in the Expression of Glucose Transporter 2 on the Peripheral Blood Insulin-Producing Cells in Type 1 Diabetic Patients After Receiving Stem Cell Educator Therapy

We are pleased to announce that Dr. Yong Zhao and his team published a new clinical research manuscript in the International Journal of Molecular Sciences (ijms), titled “Increase in the Expression of Glucose Transporter 2 (GLUT2) on the Peripheral Blood Insulin-Producing Cells (PB-IPC) in Type 1 Diabetic Patients After Receiving Stem Cell Educator Therapy”.

Glucose as the main source of cellular energy enter cells through a group of membrane proteins designated glucose transporters (GLUT 1-12). GLUT2 is widely ex-pressed in central nervous system, liver, intestine, kidney, and pancreatic islet beta cells, contributing to glucose transport and glucose sensing. GLUT2 provides relatively high capability of transporting glucose through cellular membrane. Dr. Zhao’s previous studies characterized the peripheral blood insulin-producing cells (PB-IPC) from healthy donors with high potential to give rise to insulin-producing cells. PB-IPC displayed the molecular marker GLUT2. To improve the clinical efficacy of Stem Cell Educator therapy in the restoration of islet b-cell function, Dr. Zhao and his team explored the GLUT2 expression on PB-IPC in recent onset and longstanding T1D patients. In the FDA-approved phase 2 clinical studies, patients received one treatment with the Stem Cell Educator therapy. Peripheral blood mononuclear cells (PBMC) were isolated for flow cytometry analysis of PB-IPC and other immune markers before and post the treatment with Stem Cell Educator therapy. Flow cytometry revealed that both recent onset and longstanding T1D patients displayed very low levels of GLUT2 on PB-IPC. After the treatment with Stem Cell Educator therapy, the percentages of GLUT2+CD45RO+ PB-IPC were markedly increased in these T1D subjects. Notably, we found that T1D patients shared common clinical features with patients with other autoimmune and inflammation-associated diseases such as displaying low or no expression of GLUT2 on PB-IPC at baseline and exhibiting high profile of inflammatory cytokine IL-1b. Flow cytometry demonstrated that their GLUT2 expressions on PB-IPC were also markedly upregulated and the levels of IL-1b-positive cells were significantly downregulated after the treatment with Stem Cell Educator therapy.

Stem Cell Educator therapy could upregulate the GLUT2 expression on PB-IPC and restore their function in T1D patients, leading to the improvement of clinical outcomes. Clinical data demonstrated that T1D subjects markedly increased their C-peptide levels (a by-product of insulin production) relative their baseline levels in the 1st month post treatment with Stem Cell Educator therapy, with the improved sugar control and the reduction of HbA1C and total insulin dosages. Some of these T1D subjects stopped the external insulin. These clinical data advances current understanding about the molecular mechanisms underlying the Stem Cell Educator therapy, which can be expanded to treat patients with other autoimmune and inflammation-associated diseases.

Throne Welcomes Renowned Ophthalmologist, Dr. Robin Ross, as Director of Ophthalmology

Here at Throne Biotechnologies, we are pleased to announce Dr. Robin Ross, M.D., MPH, CPH as our Director of Ophthalmology. Dr. Ross is the Board Certified American Board of Ophthalmology and Board Certified National Board of Public Health.

Dr. Robin Ross specializes in ophthalmology with a subspecialty in retina and vitreous disorders; she and has been an accomplished, board-certified surgeon for 25 years. Throughout her career, she has championed technology and clinical research to improve the quality of compassionate care delivered to her patients.  She was one of the first to embrace non face down positioning for macular hole patients, embrace 25g surgical technology and utilize wide angle imaging to enhance retinal care in underserved areas.  She spent most of her career in private practice near Flint, Michigan battling diabetic retinopathy, glaucoma and retinopathy of prematurity until the University of Michigan acquired her practice.

She was born in California and attended Stanford University on scholarship. She received her medical degree from Cornell University Medical College in New York City where she was a Scudder Fellow.  As a medical student, she was part of a revolutionary research team that developed perfluorocarbon liquid to repair detached retinas.

She completed her ophthalmology residency at the prestigious University of Iowa where she was awarded the Charles D. Phelps Faculty Award for developing a community clinic.  She was one of the first residents in the US to serve as a section editor for Archives of Ophthalmology. She was awarded the Heed Fellowship throughout her 2-year Vitreoretinal fellowship at Associated Retinal Consultants in Michigan.

Dr. Ross has conducted ophthalmology training worldwide and is certified by the International Red Cross for Health Emergencies.  She completed her Master of Public Health at Johns Hopkins Bloomberg School of Public Health to improve quality of eye care delivery to patients in the US and Globally. She received the Fulbright Specialist Award in 2017 while working with the NIH in Liberia to train eye professionals and conduct clinical research on Ebola.  

Dr. Ross came to University of Arizona in 2018.  Her private practice, Global Retina Institute, is focused on personalized eye care.  Her non-profit, Red Rover Ventures, is focused on research, education and development with the first private eye simulation center in the US focused on eye care training.  Dr. Ross believes ‘Vision is more than eyesight’ and as Nobel Prize winner Albert Schweitzer said, “The purpose of human life is to serve, and to show compassion and the will to help others.” 

“Stem Cell Educator Therapy displayed inspiring clinical outcomes,” said Dr. Ross. “I am happy to join the effort to bring this technology to patients who have eye diseases which are devastating with no cure.”

Welcome Dr. Ross, we are excited and thrilled to have you on our team!

Throne Received FDA Approval on Regenerative Medicine Advanced Therapy (RMAT) Designation by Using Stem Cell Educator Therapy to Treat Type 1 Diabetes

Paramus, New Jersey (April 24, 2024) - Throne Biotechnologies is one of the global-leading biotech companies aiming to find a cure for type 1 diabetes. We are excited to announce that Throne achieved the FDA approval on the Regenerative Medicine Advanced Therapy (RMAT) designation by using Stem Cell Educator therapy to treat type 1 diabetes. RMAT designation is one of the expedited FDA programs for regenerative medicine therapies to treat patients with serious or life-threating diseases.

    Type 1 diabetes (T1D), one of the popular autoimmune diseases, requires life-long management with daily insulin injections. Insulin therapy is not a cure. Most diabetic patients cannot achieve the physiological sugar controls by using current expansive advanced technologies such as continuous glucose monitoring systems (CGMS), insulin delivery systems, wearables, and mobile medical apps. The quality of life in T1D patients has been significantly affected by the disappointing outcomes of recent clinical trials, which have highlighted the limits of conventional immune therapy and underscore the need for novel approaches that not only overcome multiple immune dysfunctions, but also help restore islet β cells. To address these two key issues, Dr. Yong Zhao at Throne Biotechnologies (Throne) has developed a unique and novel procedure designated the Stem Cell Educator therapy. With this patented technology, the patient’s immune cells are collected by a blood cell separator and treated with cord-blood-derived multipotent stem cells (CB-SC), after which “educated” immune cells (Gleukocellâ) are returned to the patient’s blood circulation. Over the last 12 years, this innovative technology has been evaluated through international multi-center clinical studies, which have demonstrated its efficacy and safety. Stem Cell Educator therapy is the only therapy to date to safely and efficiently correct autoimmunity and restore β cell function in T1D patients. Additional pilot studies demonstrated the therapeutic potentials of Stem Cell Educator therapy to heal patients with other autoimmune or inflammation-associated diseases such as alopecia areata (AA), type 2 diabetes (T2D), lupus, psoriasis, Hashimoto’s disease, and long COVID. Stem Cell Educator therapy hold great promise to revolutionize the treatment of diabetes and eliminate the need for lifelong insulin therapy, without the safety and ethical concerns associated with conventional immune and/or stem cell-based approaches.

New Pre-Clinical Studies Demonstrate Cord Blood Stem Cells (CB-SC) Ameliorate the Graft-vs-Host Disease (GvHD) Involved in the Allogeneic Hematopoietic Stem Cell Transplantation

We are pleased to announce that Dr. Yong Zhao collaborated with his colleagues Dr. Robert Korngold’s group at the Center For Discovery and Innovation (CDI) of Hackensack Meridian Health,  published a new manuscript in Transplantation and Cellular Therapy, (the official journal of the American Society for Transplantation and Cellular Therapy), titled “Cord Blood Derived-Multipotent Stem Cells Ameliorate In-Vitro/In-Vivo Alloreactive Responses and this Effect is Associated with Exosomal Microvesicles in Vitro”.

Animal studies demonstrated that CB-SC ameliorated the development of GvHD responses in a xenogeneic human peripheral blood mononuclear cells (PBMC)-induced NSG mouse model. These results indicate that CB-SC can directly and indirectly attenuate alloreactive CD4 T cell activation and proliferation in vitro with a potentially related exosomal microvesicles (EV) mode of action and may have potential utilization as a cell therapy to control donor T cell mediated GvHD responses in vivo.

New Studies Revealed the New Molecular Mechanisms Underlying Stem Cell Educator Therapy on Human B Cells

We are happy to announce that Dr. Yong Zhao and his team published a new manuscript that revealed the new molecular mechanisms underlying Stem Cell Educator therapy for the treatment of type 1 diabetes and other autoimmune diseases. This manuscript was published Feb. 2, 2024 in the peer-reviewed International Journal of Molecular Sciences (IJMS), titled “Suppression of B-Cell Activation by Human Cord Blood-Derived Stem Cells (CB-SCs) through the Galectin-9-Dependent Mechanism”.

B cells have an important role in maintaining homeostasis and the adaptive immune response through antibody production, antigen presentation, and the production of multiple cytokines. Dysfunctions of B cells, including the production of auto-antibodies and the loss of regulatory B-cell function, are actively contributed to the pathogenesis of diabetes and multiple autoimmune diseases. The galectin family comprises the glycan-binding proteins that are expressed by diverse types of cells and tissues, including immune and non-immune cells.

Dr. Zhao and his teams developed the Stem Cell Educator therapy among multiple clinical trials based on the immune modulations of multipotent cord blood-derived stem cells (CB-SC) on different compartments of immune cells, such as T cells and monocytes/macrophages, in type 1 diabetes and other autoimmune diseases. The current study revealed that CB-SC directly displayed multiple immune modulations on B-cell proliferation and differentiation and antibody productions through the Galectin-9-mediated mechanism and calcium flux/Akt/Erk1/2 signaling pathways. These findings lead to a better understanding of the molecular mechanisms of Stem Cell Educator therapy to treat T1D and other autoimmune diseases (e.g., myasthenia gravis and lupus) in clinics. Additionally, Stem Cell Educator therapy may fundamentally correct the activated B cell-mediated autoimmunity and reduce the auto-antibody productions, without the safety concerns that are associated with using steroid and conventional immunotherapies.

Holiday Greetings: Happy New Year

Over the last year, Throne has made significant progresses in the FDA-approved clinical trials of Stem Cell Educator therapy for the treatment of type 1 diabetes (T1D), alopecia areata (AA) and other inflammation/autoimmune-associated diseases. In this Holiday season, we sincerely appreciate all staffs, collaborators, shareholders, investors, advisers, regulators, patients, and their families for their long-term supports and prayers!

 Best Wishes and Happy New Year to All!

 Yong Zhao, MD, PhD

Dr. Yong Zhao is invited as Guest Editor for the journal Biomedicines

We are pleased to announce that Dr. Yong Zhao, founder and CEO of Throne Biotechnologies, is invited by an academic journal Biomedicines to edit Special Issue, “Mitochondria in Human Health and Diseases”. 

        Mitochondria, an energy center integrating with other organelles, contribute to a variety of cellular activities and stress responses through the dynamic properties of mitochondria such as fusion, fission and mitophagy, leading to the maintenance of cellular homeostasis. Recent advances in mitochondrial biology demonstrate that mitochondria not only act as organelles of “a cellular power plant” for ATP production to energize cellular/molecular activities of daily life, but also circulate in human peripheral blood and function as novel mediators involved in the crosstalk among different cells, tissues, and organs in physiological and pathological conditions. Increasing evidence demonstrates that mitochondria dominate the proliferation and differentiation of stem cells. Notably, mitochondria can penetrate the nuclear membrane, leading to cellular reprogramming and the generation of autologous multipotent stem cells. This Special Issue focuses on recent progresses in the basic research and clinical studies of mitochondria to facilitate its translational potential in clinics.  Researchers and clinicians are encouraged to submit insightful reviews and research papers on the topic of mitochondria.

Throne Welcomes Renowned Pediatrician, Dr. Richard Fox, as Pediatric Medical Director

Here at Throne Biotechnologies, we are pleased to announce Dr. Richard Fox, M.D., as our Pediatric Medical Director.

Dr. Fox received his medical degree from the University of Minnesota in 1975 and his law degree from Santa Clara University in 2009. He is board-certified in Pediatrics and board-eligible in both Pediatric Critical Care Medicine and Pediatric Pulmonology. He has held faculty positions at the University of Colorado and Harvard Medical School. He has published 24 peer-reviewed original scientific papers and numerous abstracts and case reports. He has served on several boards, both non-profit and for-profit.

“Over the last 12 years, the Stem Cell Educator Therapy has shown amazing and inspiring clinical results,” said Dr. Fox. “Given that many of the estimated nearly 20,000 per year of newly diagnosed children with type 1 diabetes are younger children, we will need more specialized care for them. I am happy to join the effort to bring this technology to pediatric patients who have diseases which are devastating with no cure.”

Welcome Dr. Fox, we are excited and thrilled to have you on our team!

Revisiting the Pathogenesis of Type 1 Diabetes: Importance of Neural Input to Pancreatic Islets and the Therapeutic Capability of Stem Cell Educator Therapy to Restore Their Integrity

Type 1 diabetes (T1D) is an autoimmune disease with a shortage of islet β cells. To date, the etiology of T1D remains elusive. Increasing clinical evidence and animal studies demonstrate that autoimmune cells are directed against the nervous system of pancreatic islets, contributing to the development of T1D. Therefore, it highlights the necessity to explore novel clinical approaches to fundamentally correct the T1D autoimmunity not only focusing on islet β cells but also on protecting the islet nervous system. This allows the restoration of the integrity of islet innervation and the normal islet β-cell function.

 

To address these issues, Throne developed a novel technology designated the Stem Cell Educator therapy, based on immune education by human cord-blood-derived multipotent stem cells (CB-SC). International multicenter clinical trials demonstrated its clinical safety and efficacy to treat T1D and other autoimmune diseases. Stem Cell Educator TM therapy may have the potential to revolutionize the treatment of T1D, without the safety and ethical concerns associated with conventional immune and/or stem cell-based therapies.

 

For more information, please read the review article that is newly published by Dr. Yong Zhao in the peer-reviewed journal Biomedicines on Feb. 16, 2023.

Throne Starts the US FDA-Approved Clinical Trials of Stem Cell Educator Therapy to Treat Autoimmune Diseases

Throne Biotechnologies (Throne) is a clinical-stage therapeutic company with a disruptive stem cell technology that can fundamentally reverse type 1 diabetes (T1D), alopecia areata (AA) and other autoimmune diseases through immune education of Stem Cell Educator therapy (“Educator Therapy”) at the root causes. Over last 10 years, international multicenter clinical trials in Spain, China, and the United States have strongly demonstrated the clinical safety and efficacy of Stem Cell Educator therapy in more than 200 patients aged from 3 to 70 years old.

    Throne received the approvals from the United States Food and Drug Administration (FDA) by using Stem Cell Educator therapy to treat patients with type 1 diabetes and alopecia areata. These clinical trials have been delayed due to the pandemic. Recently, Throne received the License from the New Jersey Department of Health. We are happy to announce that both clinical trials have been started at Throne in collaboration with Fresenius Medical Care, a renowned healthcare company in North America.

 

For more information about these two clinical trials, please visit clinicaltrials.gov for type 1 diabetes with an identifier No. NCT04011020 and alopecia areata with an Identifier No. NCT04011748.

From left to right: Christopher Tatesure (Fresenius), Dr. Yong Zhao (CEO at Throne), Dr. Boris Veysman (Medical Director at Throne), Darinka Povrzenic (Vice President at Fresenius), and Lilla Wojciechowski (Fresenius).

Throne’s Crowd Funding Campaign at StartEngine Achieved beyond Our Expectations

We are happy to announce that Throne’s Equity Crowdfunding Campaign was closed yesterday, successfully raising more than enough money to kickstart our Clinical Trials at Throne Biotechnologies (Throne). We sincerely appreciate all 102 investors for their generosity towards funding the new practical cure for type 1 diabetes and alopecia areata. Our appreciation also goes out to all the wonderful Staff members at Start Engine for their strong support and friendly service during the entire process from our first investor to our last. Your support and prayers have made it possible for us at Throne to find a cure for type 1 diabetes and for all autoimmune diseases.

 Our next focus of operations is gears towards starting our clinical trials using Stem Cell Educator therapy for the treatment of type 1 diabetes and alopecia areata.

 If you have any questions, please feel free to contact me at Yong.Zhao@ThroneBio.com

 ----Dr. Yong Zhao, MD, PhD (Founder and CEO of Throne)

Final Hours Left to Invest at the Throne’s Equity Crowdfunding Campaign

We sincerely appreciate all our investors who kindly care and support the Throne’s Crowdfunding Campaign at StartEngine, leading to the initiation of our clinical trials of Stem Cell Educator therapy soon. This campaign is going to be closed at the midnight today (April 30). We will focus on the preparation and starting our clinical trials. We are looking forward to collaborating with you and moving forward with fruitful results. Visit our page at https://www.startengine.com/throne-biotechnologies to invest.

1 Day Left to Invest at the Throne’s Equity Crowdfunding Campaign

We sincerely appreciate all our investors who kindly care and support the Throne’s Crowdfunding Campaign at StartEngine, leading to the initiation of our clinical trials of Stem Cell Educator therapy. This campaign is going to be closed on April 30. Next, we will focus on the preparation and starting our clinical trials. We are looking forward to collaborating with you and crossing the finish line. Visit our page at https://www.startengine.com/throne-biotechnologies to invest.

7 Days Left to Invest at the Throne’s Equity Crowdfunding Campaign

We are so thankful for all of our investors so far and sincerely appreciate all your generosities to support the clinical trials of Stem Cell Educator therapy to treat type 1 diabetes and alopecia areata through this campaign at StartEngine. We are happy to announce that we are going to start these clinical trials in June, about two months away from now. Throne’s equity crowdfunding campaign will be closed soon on April 30th. We look forward to the growth that would not be possible without your investment. Visit our page at StartEngine to invest.

Why Can Stem Cell Educator Therapy Be Utilized to Treat Type 2 Diabetes?

Type 2 diabetes (T2D) is the most common type of diabetes, with prevalence increasing worldwide due to the popularization of a Western lifestyle characterized by overnutrition and limited exercise. According to the International Diabetes Federation (IDF) Diabetes Atlas Tenth edition 2021(https://idf.org/aboutdiabetes/what-is-diabetes/facts-figures.html), approximately 537 million adults (20-79 years) are living with diabetes. The total number of people living with diabetes is projected to rise to 643 million by 2030 and 783 million by 2045. Diabetes-associated complications (e.g., cardiovascular diseases, stroke, blindness, kidney failure, and emotional stress) markedly decrease quality of life of T2D patients, limiting the productivity of individuals with the disease and creating significant economic and social burdens. Thus, finding a cure for T2D is a top priority.

    Insulin resistance is the key issue causing T2D. Mounting clinical evidence and animal studies point to the involvement of monocytes/macrophage-associated immune dysfunctions as crucial issues in insulin resistance in T2D, suggesting that immune modulation may be a useful tool in treating the disease. The failures of using conventional approaches to controlling inflammation and immune dysfunction of type 1 diabetes (T1D) should enlighten the development and testing of novel approaches in T2D. Currently, insulin therapy and FDA-approved medications for T2D patients only treat the symptoms and cannot fully address these fundamental issues causing insulin resistance. 

    To determine the clinical efficacy of Stem Cell Educator therapy in T2D, Dr. Zhao and colleagues found that about 70% of T2D patients achieved the improved metabolic control, with marked reduction of median glycated hemoglobin (HbA1 C) values from 8.61% ± 1.12 at baseline to 7.9% ± 1.22 at 4 weeks post-treatment (P = 0.026), and to 7.25% ± 0.58 at 12 weeks post-treatment with Educator therapy (P = 2.62E-06) in long-standing T2D subjects. Homeostasis model assessment (HOMA) of insulin resistance (HOMA-IR) revealed that insulin sensitivity was improved, as well as significantly reduced inflammation markers after receiving Stem Cell Educator therapy. Notably, the islet beta-cell function in long-standing severe T2D subjects (15 ~24 years) was markedly recovered, as established by the restoration of C-peptide levels at both fasting and post glucose challenging. This clinical efficacy could be retained over four years after receiving one treatment with Stem Cell Educator therapy. Therefore, Stem Cell Educator therapy holds great promise for improving diabetic treatment and finding a cure for diabetes.

Monocytes/macrophages are important front line of immune cells in humans. Based on the phenotypic differences, macrophages are simply characterized with type 1 macrophages (M1, inflammatory) and type 2 macrophages (M2, inflammatory). Mechanistic studies have shown that the percentage of monocytes expressing an M1 macrophage marker was markedly decreased in T2D patients four weeks after Stem Cell Educator therapy and that co-culture of activated monocytes with stem cells CB-SC significantly down-regulated numbers of inflammation-related genes, including chemokines and cytokines. To further explore the molecular mechanisms underlying the immune modulation of Educator therapy on monocytes/macrophages, our recent study demonstrated that CB-SC could release exosomes (designated cbExosomes, see following Figure) that promoted the M2 differentiation of monocytes. Exosomes belong to a family of nanoparticles with diameters ranging 30‒150 nm. Thus, Stem Cell Educator therapy through the action of CB-SC counteract the chronic inflammation by releasing cbExosomes, which promote monocyte differentiation into anti-inflammatory M2 macrophages, contributing to the control of inflammation and producing the long-lasting clinical outcomes in metabolic control for individuals with moderate or severe T2D who receive a single treatment.

Collectively, Stem Cell Educator therapy has the great therapeutic potential to revolutionize the treatment of both type 1 and type 2 diabetes and eliminate the need for lifelong insulin therapy, without the safety and ethical concerns associated with conventional immune and/or stem cell-based approaches.

    We appreciate your financial support to facilitate the clinical transition of Stem Cell Educator therapy into a practical care. Please visit the Throne campaign page to learn more and invest on StartEngine: https://www.startengine.com/throne-biotechnologies


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