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.
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.
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 from the Second Xiangya Hospital of Central South University: the children T1D trial (NCT01996228) has demonstrated the clinical safety and efficacy of Stem Cell Educator therapy for the treatment of children with type 1 diabetes (n = 40). This project has been supported by the Ministry of Science and Technology of the P.R. China.
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.
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. 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).
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 (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
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.
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.
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.
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.
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”.
Dr.Yong Zhao was invited and gave a lecture at The XIII Congress of the Catalan Association of Diabetes (Barcelona, Spain) about Stem Cell Educator Therapy.
Dr. Yong Zhao was invited as a keynote speaker and gave a lecture on “Application of Umbilical Cord Blood Stem Cells in Diabetes Management”, at the 18th Scientific Meeting of the Chinese Diabetes Society (CDS, Guangzhou, China).
The FDA-registered cord blood bank CORD:USE in Orlando (USA) and Tianhe Stem Cell Biotechnologies enter into a Long-Term Partnership from current academic collaboration to future business collaboration on Stem Cell Educator therapy in clinic.
Tianhe’s patent on human peripheral blood stem cells has been granted by United States Patent Office. These autologous stem cells are suitable for the treatment of diabetes, cardiovascular diseases, neurodegenerative diseases, and others.
Tianhe’s international patent on human cord blood stem cells has been granted by European Patent Office. This patent will cover the countries in European Union.
Stem Cell Educator therapy becomes one of the top 3 technologies to practically cure type 1 diabetes among over 300 current clinical trials in the world. Read more on Juvenile Diabetes Cure Alliance website: Exhibit 10 in State of the Cure 2013