Tianhe received FDA approval on Phase 2 clinical study of Stem Cell Educator therapy in type 1 diabetes

Type 1 diabetes (T1D) is a major public health concern, and its incidence and prevalence are increasing worldwide. In the US, ~ 1.25 million people are living with the disease, and that number is expected to increase to ~ 5 million by 2050. T1D patients requires life-long management with daily glucose monitoring and insulin injections that do not fully control the broad range of long-term negative health effects that can include heart disease, nerve damage, and blindness. Given the prevalence, severity, and cost of T1D, researchers and doctors have long sought a more effective treatment or cure, without much success.

Tianhe has developed a novel globally-patented Stem Cell Educator (SCE) technology designed to reverse the autoimmune response in Type 1 diabetes (T1D), Alopecia Areata and other autoimmune diseases. Previous multi-center international clinical studies in more than 100 diabetic patients (aged 3 to 56 years old) with T1D, demonstrated that SCE therapy has shown lasting reversal in autoimmunity in T1D patients, including improved C-peptide levels (an indicator for insulin production from islet b cells), reduced median glycated hemoglobin A1C (HbA1C) values, and decreased median daily usage of insulin, with long-lasting (4 years) clincial effects. These data highlight the SCE therapy may provide the unmet medical need for the treatment of T1D.  It has been recognized as one of the top-10-leading technologies for the practical cure of T1D, reported by Juvenile Diabetes Cure Alliance (JDCA, New Yok). Currently, this FDA-approved Phase 2 clinical study will be performed at Hackensack University Medical Center (Hackensack, NJ). For more information, please contact info@TianheCell.com

Tianhe received FDA approval on the Phase 2 alopecia areata study

Alopecia areata (AA) is a common autoimmune disease that results in loss of body hair in varying degrees. The condition is estimated to affect more than 6.8 million people in the United States (naaf.org), with a worldwide prevalence of 0.1% to 0.2%. AA and its variants such as alopecia totalis (AT, total loss of scalp hair) and alopecia universalis (AU, complete loss of body hair) can have devastating effects on patients’ quality of life and social functioning. At present, curative therapy for AA does not exist.

Tianhe has developed a novel globally-patented Stem Cell Educator (SCE) technology designed to reverse the autoimmune response in Type 1 diabetes (T1D), Alopecia Areata and other autoimmune diseases. Previous clinical trial demonstrated the safety and efficacy of the SCE therapy for the treatment of AA and produced lasting improvement in hair regrowth in subjects with moderate or severe AA. Currently, this FDA-approved Phase 2 clinical study will be performed at Hackensack University Medical Center and Department of Dermatology/School of Medicine at Yale University. For more information, please contact info@TianheCell.com

Stem Cell Educator therapy remains the global-leading technology for the treatment of type 1 diabetes

The Juvenile Diabetes Cure Alliance (JDCA) summarizes recent progress made during 2018 toward a practical cure for type 1 diabetes (T1D). To date, there are 518 clinical trials in T1D, registered in ClinicalTrials.gov. Only ten (10) active projects are being tested in clinical trials as “Practical Cure Projects”. Stem Cell Educator therapy, patented technology by Tianhe Stem Cell Biotechnologies, remained in the top list of these ten technologies. See JDCA annual report 2018.  

Stem Cell Educator (SCE) therapy, developed and patented by Dr. Yong Zhao at University of Illinois at Chicago, uses Cord Blood Stem Cells to “educate” autologous mononuclear cells, reversing autoimmunity in patients with T1D and providing lasting improvement of islet beta-cell function (C-peptide levels), reduced median glycated hemoglobin A1C (HbA1C) values, and decreased median daily usage of insulin. SCE has been proven safe and effective in Chinese and Caucasian subjects for the improvement of T1D and other autoimmune diseases.

Tianhe received the validation of mycoplasma testing for GMP production

In Jan. 3rd and 4th, ThermoFisher offered an onsite training at Tianhe GMP lab for the detection of mycoplasma by using the MycoSEQ Mycoplasma Real-Time PCR Detection Kit. This detection was conducted according to U.S. FDA Current Good Manufacturing Practice regulations (FDA 21 CFR Parts 210, 211) and Electronic Records and Signatures (FDA 21 CFR Part 11). After mycoplasma detection training and validations into manufacturing operations, Tianhe Stem Cell Biotechnologies (Tianhe) has been qualified and ready to provide clinical manufacturing.

FDA-approved clinical trial of Stem Cell Educator therapy has started in the United States

Stem Cell Educator (SCE) therapy, developed and patented by the Dr. Yong Zhao, uses Cord Blood Stem Cells to “educate” autologous immune cells, reversing autoimmunity in patients with Type 1 Diabetes (T1D) and providing lasting improvement of C-peptide levels, reduced median glycated hemoglobin A1C (HbA1C) values, and decreased median daily usage of insulin. SCE has been proven safe and effective in Chinese and Spanish subjects for the improvement of T1D and other autoimmune diseases. FDA approved the Phase I/II clinical trial of Stem Cell Educator therapy for the treatment of T1D. This clinical has been started at Hackensack University Medical Center, the biggest hospital in New Jersey and top 3 in New York metropolitan area. For more information, please visit HackensackUMC with Study ID# Pro00006262.

Tianhe builds up a GMP lab in New Jersey, United States.

Tianhe builds up a new Good Manufacturing Practice (GMP) lab in Paramus, New Jersey. This GMP lab has been successfully validated with the international ISO5 (Class 100) standards for cellular productions and received Certification. Tianhe’s patented technology Stem Cell Educator therapy has been achieved the FDA approval for phase I/II clinical trial in type 1 diabetes at Hackensack University Medical Center, the biggest hospital in New Jersey and top 3 in New York metropolitan area. This GMP lab is going to manufacture Stem Cell Educators and serve clinical studies at Hackensack UMC.

Dr.Yong Zhao presented his recent discovery on platelet-derived mitochondria at the 8th World Congress on Targeting Mitochondria (Berlin, Germany)

Dysfunctions of mitochondria are recognized as major factors contributing to the development of cancer, diabetes, aging and other chronic diseases. Dr.Yong Zhao was invited to orally present his recent discovery at the annual meeting of World Mitochondria Society, the 8th World Congress on Targeting Mitochondria (Oct.23-24, Berlin, Germany). Dr. Zhao introduced the novel function of platelet- released mitochondria in immune modulation, improving the regeneration of pancreatic islet beta cells, and enhancement of islet beta-cell functions in humans.

Beijing 301 Military Hospital opens up a new clinical trial of Stem Cell Educator therapy for the treatment of insulin resistance in type 2 diabetes

The Institutional Review Board (IRB) at People’s Liberation Army Hospital (301 Hospital, Beijing) approved the clinical trial of Stem Cell Educator therapy for the treatment of diabetic patients. Dr.Yong Zhao at Hackensack University Medical Center (New Jersey, USA) is collaborating with Dr.Yiming Mu at the Section of Endocrinology (Beijing, China) to explore the molecular mechanisms underlying the insulin resistance in type 2 diabetes. This project has been supported by National Natural Science Foundation of China. The previous study has demonstrated the safety and clinical efficacy of Stem Cell Educator therapy for the treatment of type 2 diabetes.  

Press release: the children T1D trial has demonstrated the clinical safety and efficacy of Stem Cell Educator therapy for the treatment of children with type 1 diabetes.

Dr.Zhao and his team reveal new mechanisms underlying Stem Cell Educator therapy and open up new avenues to improve the treatment of diabetes in clinics.

The features of platelets have been changed after the treatment with Stem Cell Educator therapy in diabetic patients. Platelets and their released mitochondria display immune tolerance-associated markers that can modulate the proliferation and function of immune cells. Using freshly-isolated human pancreatic islets, ex vivo studies established that platelet-releasing mitochondria can migrate to pancreatic islets and be taken up by islet beta cells, leading to the proliferation and enhancement of islet beta-cell functions. This article has been published at the STEM CELLS Translational Medicine.

Dr.Zhao and his team published four-year follow-up studies demonstrated the long-term safety and clinical efficacy of Stem Cell Educator therapy for the treatment of type 1 diabetes (T1D) and T2D.

Clinical data revealed the long-lasting therapeutic efficacy of Stem Cell Educator (SCE) therapy in T1D and T2D subjects after receiving one treatment with SCE therapy.  Specifically, recent onset T1D patients could achieve normal fasting C-peptide levels and remain completely recovered with no relapse after 4 years. To our knowledge, this is the first long-term clinical study demonstrated that islet β cell function has been completely and safely rescued in these recent onset T1D subjects after controlling the autoimmunity by the SCE therapy. Read more in the article at the STEM CELLS Translational Medicine.

The Ministry of Science and Technology of China funded the Stem Cell Educator Therapy for the Treatment of Children with Type 1 Diabetes.

The Ministry of Science and Technology of China funded the Stem Cell Educator therapy for the treatment of children with type 1 diabetes. This project is an international collaboration between Dr. Yong Zhao at Hackensack University Medical Center (USA) and Dr. Zhiguang Zhou at Central South University (China).  

The FDA-approved clinical trial of Stem Cell Educator therapy is started to treat type 1 diabetic patients at Hackensack University Medical Center.

Stem Cell Educator (SCE) therapy - developed and patented by Dr.Zhao – which uses only autologous mononuclear cells that are externally exposed to cord blood stem cells adhering to the SCE device, has previously been proven safe and effective in Chinese and Spanish subjects for the improvement of Type 1 diabetes (T1D) and other autoimmune diseases. If you are interested to join this trial, please contact Dr.Zhao at Yong.Zhao@HackensackMeridian.org

FDA approves the Stem Cell Educator Therapy for type 1 diabetes

FDA (The United States Food and Drug Administration) approved the Phase I/II clinical trial of Stem Cell Educator therapy for the treatment of type 1 diabetic patients at Hackensack University Medical Center. This big milestone achieved by Dr. Yong Zhao and his team will open up new avenues for the clinical treatment of diabetes and other autoimmune diseases

The Third International Conference on Regenerative Medicine was held at the Vatican City.

This groundbreaking Conference gathered the world’s leading scientists in cell therapy, physicians, ethicists and leaders of faith, legislators, and philanthropists to discuss the latest cellular therapy breakthroughs in cancer, diabetes, autoimmune diseases, and rare diseases. The Pope Francis and the American Vice President Biden gave encouraging speeches respectively on the significance of cellular therapy and building up the international collaborations. Dr.Zhao presented the Phase II clinical data on the Stem Cell Educator therapy in type 1 diabetes.  

Media story:

WCBS 2 - Dr. Max Gomez - Diabetes Research Dr. Yong Zhao and Dr. Andrew Pecora (skip to 1:22)

Conference presentation:

Cellular Horizons Day 1 - Cell Therapy Research Discussion for Type 1 Diabetes (skip to 23:43)

 

Dr. Zhao to present research and technology in the Vatican City

Dr.Yong Zhao is invited to attend the Third International Conference on Regenerative Medicine (The Vatican, April 28-30, 2016).This exclusive international event will gather the world’s leading cell therapy scientists, physicians, ethicists and leaders of faith, government and philanthropy to discuss the latest cellular therapy breakthroughs in Cancer, Diabetes and Autoimmune Diseases.

Event:

http://celltherapyconference2016.com/

Bio:

http://celltherapyconference2016.com/2015/11/19/yong-zhao-md-phd/

New article published in EBioMedicine (Spain)

Dr. Zhao and his partners in Spain published the featured article "Modulation of Autoimmune T-Cell Memory by Stem Cell Educator Therapy: Phase 1/2 Clinical Trial" in EBioMedicine. This published study demonstrates that Stem Cell Educator Therapy can correct autoimmune T-Cell memory.

http://www.ebiomedicine.com/article/S2352-3964(15)30193-6/abstract

 

New alopecia areata trial published in BMC Medicine

A new Phase I/II clinical trial in autoimmune disease alopecia areata has been published in BMC Medicine, titled "Hair Regrowth in Alopecia Areata Patients Following Stem Cell Educator Therapy". Findings from this trial provide visible evidence that Stem Cell Educator therapy can control the autoimmunity and lead to hair regrowth.  

http://www.biomedcentral.com/1741-7015/13/87

Lecture at Immunology of Diabetes Society 14th International Congress (Munich, Germany)

Dr. Yong Zhao will present the clinical data from Spanish clinical trial at Immunology of Diabetes Society 14th International Congress (Munich, Germany), titled “Correct the autoimmune memory by Stem Cell Educator therapy in Caucasian type 1 diabetic subjects: phase I/II clinical trial”.

http://www.ids2015.org/