Stem Cell Educator Therapy for Type 1 Diabetes
Recruiting in Palo Alto (17 mi)
+1 other location
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: Throne Biotechnologies Inc.
Must not be taking: Immunosuppressants, Chemotherapy, Anticoagulants
Disqualifiers: Coronary artery disease, Active infection, Autoimmune diseases, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial uses Stem Cell Educator (SCE) therapy, which treats a patient's own blood cells with umbilical cord blood stem cells. It targets patients with Type 1 diabetes who need better treatment options. The therapy helps the immune system stop attacking the pancreas by 'educating' the immune cells. Stem Cell Educator therapy has been evaluated through international clinical studies, demonstrating its safety and efficacy in Type 1 diabetes and other autoimmune diseases.
Do I need to stop my current medications for the trial?
The trial requires that you stop using immunosuppressive medications at least one month before enrollment. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
What data supports the idea that Stem Cell Educator Therapy for Type 1 Diabetes is an effective treatment?
The available research shows that Stem Cell Educator Therapy has been tested in international clinical trials and has demonstrated safety and effectiveness in treating Type 1 Diabetes. This treatment helps correct the immune system's attack on the body's own cells and supports the recovery of insulin-producing cells in the pancreas. Unlike other treatments, it does not have the safety and ethical concerns associated with traditional therapies. The therapy has shown potential to improve the body's ability to manage blood sugar levels, which is crucial for people with Type 1 Diabetes.
12345What safety data exists for Stem Cell Educator Therapy in treating Type 1 Diabetes?
Stem Cell Educator Therapy has been evaluated for over 10 years through international multi-center clinical studies, demonstrating its clinical safety and efficacy in treating Type 1 Diabetes and other autoimmune diseases. The therapy is based on immune education by cord-blood-derived multipotent stem cells and has shown potential to correct autoimmunity and restore beta cell function without the safety and ethical concerns associated with conventional therapies.
12467Is Stem Cell Educator Therapy a promising treatment for Type 1 Diabetes?
Yes, Stem Cell Educator Therapy is a promising treatment for Type 1 Diabetes. It uses special stem cells to help the immune system work better and restore the function of insulin-producing cells in the pancreas. Clinical trials have shown it to be safe and effective, offering hope for better management of the disease.
12458Eligibility Criteria
This trial is for adults and children over 14 with Type 1 Diabetes, diagnosed within the last two years. Participants must have a certain level of C-peptide, use continuous glucose monitoring, consent to study requirements including birth control for women, and not be on immunosuppressants or have other autoimmune diseases.Inclusion Criteria
I am willing to use birth control as recommended until 6 months after treatment ends.
Your C-peptide level is higher than 0.3 ng/ml when you haven't eaten.
I am 14 years old or older.
+8 more
Exclusion Criteria
Your liver enzymes (AST or ALT) are higher than a certain limit.
I am on a blood thinner that is not aspirin.
You are pregnant or breastfeeding.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive one treatment with Stem Cell Educator (SCE) therapy
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including measurements of immune markers and glucose control
12 months
Visits at baseline, 1, 3, 6, 9, and 12 months
Participant Groups
Stem Cell Educator therapy is being tested in this trial. It involves circulating a patient's blood through a device where immune cells are 'educated' by cord blood stem cells to potentially reverse autoimmunity in Type 1 Diabetes patients.
2Treatment groups
Experimental Treatment
Group I: Treatment of T1D with Stem Cell Educator therapyExperimental Treatment1 Intervention
Recruited T1D subjects will receive one treatment with SCE therapy.
Group II: Conventional insulin therapyExperimental Treatment1 Intervention
Control group will receive conventional insulin therapy.
Stem Cell Educator Therapy is already approved in China, United States for the following indications:
🇨🇳 Approved in China as Stem Cell Educator Therapy for:
- Type 1 Diabetes
🇺🇸 Approved in United States as Stem Cell Educator Therapy for:
- Type 1 Diabetes
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Throne BiotechnologiesParamus, NJ
Hackensack Meridian HealthHackensack, NJ
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Who Is Running the Clinical Trial?
Throne Biotechnologies Inc.Lead Sponsor
Hackensack Meridian HealthCollaborator
References
Revisiting the Pathogenesis of Type 1 Diabetes: Importance of Neural Input to Pancreatic Islets and the Therapeutic Capability of Stem Cell Educator TM Therapy to Restore Their Integrity. [2023]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, we developed a novel technology designated the Stem Cell Educator TM therapy, based on immune education by human cord-blood-derived multipotent stem cells (CB-SC). International amulticenter 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.
Stem Cell Educator therapy in type 1 diabetes: From the bench to clinical trials. [2022]Type 1 diabetes (T1D) is an autoimmune disease that causes a deficit of pancreatic islet β cells. Millions of individuals worldwide have T1D, and its incidence increases annually. Recent clinical trials have highlighted the limits of conventional immunotherapy in T1D and underscore the need for novel treatments that not only overcome multiple immune dysfunctions, but also help restore islet β-cell function. To address these two key issues, we have developed a unique and novel procedure designated the Stem Cell Educator therapy, based on the immune education by cord-blood-derived multipotent stem cells (CB-SC). Over the last 10 years, this technology has been evaluated through international multi-center clinical studies, which have demonstrated its clinical safety and efficacy in T1D and other autoimmune diseases. Mechanistic studies revealed that Educator therapy could fundamentally correct the autoimmunity and induce immune tolerance through multiple molecular and cellular mechanisms such as the expression of a master transcription factor autoimmune regulator (AIRE) in CB-SC for T-cell modulation, an expression of Galectin-9 on CB-SC to suppress activated B cells, and secretion of CB-SC-derived exosomes to polarize human blood monocytes/macrophages into type 2 macrophages. Educator therapy is the leading immunotherapy to date to safely and efficiently correct autoimmunity and restore β cell function in T1D patients.
Stem cell therapy for type 1 diabetes mellitus: a review of recent clinical trials. [2021]Stem cell therapy is one of the most promising treatments for the near future. It is expected that this kind of therapy can ameliorate or even reverse some diseases. With regard to type 1 diabetes, studies analyzing the therapeutic effects of stem cells in humans began in 2003 in the Hospital das Clínicas of the Faculty of Medicine of Ribeirão Preto - SP USP, Brazil, and since then other centers in different countries started to randomize patients in their clinical trials. Herein we summarize recent data about beta cell regeneration, different ways of immune intervention and what is being employed in type 1 diabetic patients with regard to stem cell repertoire to promote regeneration and/or preservation of beta cell mass.The Diabetes Control and Complications Trial (DCCT) was a 7-year longitudinal study that demonstrated the importance of the intensive insulin therapy when compared to conventional treatment in the development of chronic complications in patients with type 1 diabetes mellitus (T1DM). This study also demonstrated another important issue: there is a reverse relationship between C-peptide levels (endogenous indicator of insulin secretion) chronic complications - that is, the higher the C-peptide levels, the lower the incidence of nephropathy, retinopathy and hypoglycemia. From such data, beta cell preservation has become an additional target in the management of T1DM 1.
Insulin-secreting adipose-derived mesenchymal stromal cells with bone marrow-derived hematopoietic stem cells from autologous and allogenic sources for type 1 diabetes mellitus. [2022]Stem cell therapy (SCT) is now the up-coming therapeutic modality for treatment of type 1 diabetes mellitus (T1DM).
Stem cell educator therapy and induction of immune balance. [2021]Type 1 diabetes (T1D) is a T cell-mediated autoimmune disease that causes the deficit of pancreatic islet β cells. A true cure has proven elusive despite intensive research pressure by using conventional approaches over the past 25 years. The situation highlights the challenges we face in conquering this disease. Alternative approaches are needed. Increasing evidence demonstrates that stem cells possess the function of immune modulation. We established the Stem Cell Educator therapy by using cord blood-derived multipotent stem cells (CB-SCs). A closed-loop system that circulates a patient's blood through a blood cell separator, briefly co-cultures the patient's lymphocytes with adherent CB-SCs in vitro, and returns the educated lymphocytes (but not the CB-SCs) to the patient's circulation. Our clinical trial reveals 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 subjects with long-standing T1D.
Efficacy and safety of stem cells transplantation in patients with type 1 diabetes mellitus-a systematic review and meta-analysis. [2021]Stem cells (SCs) therapy is a new promising therapeutic modality for type 1 diabetes (T1DM). We performed a systematic review and meta-analysis to evaluate the efficacy and safety of stem cells transplantation (SCT) in patients with T1DM. We searched five literature databases (MEDLINE, EMBASE, Web of Science, WanFang and CENTRAL) up to 31 October 2019. 29 studies (487 patients with T1DM) were included in our meta-analysis. There was no substantial publication bias. Meta-analysis showed the SCT had significant effect to decrease HbA1c (SMD, 1.40; 95% CI, 0.93 to 1.86; p < 0.00001; I2 = 89%) and to improve C-peptide levels (SMD, -0.62; 95% CI, -1.22 to -0.02; p = 0.04; I2 = 92%) at 1 year follow-up. Subgroup analyses showed the heterogeneity level of the results was high. Significant improvement of metabolic outcomes was observed in the subgroups of mesenchymal stem cells (MSCs) combined with hematopoietic stem cells (HSCs) and HSCs. The older age showed significant association with the efficacy in HSCs subgroup. The higher GADA positive rate before treatment also significantly associated with the decrease of daily insulin requirement. The transient insulin independence rate at last follow-up was 9.6 per 100 person-years (95% CI: 5.8-13.5%). The mean length of insulin independence was 15.6 months (95% CI: 12.3-18.9). The mortality of SCT was 3.4% (95% CI: 2.1-5.5%). Therefore, SCT is an efficacious and safe method for treating patients with T1DM especially in the subgroups of MSCs + HSCs and HSCs. Well designed, double blind and randomized controlled trails with large sample size and long-term follow-up are needed for further evaluation.
Circulating Hematopoietic (HSC) and Very-Small Embryonic like (VSEL) Stem Cells in Newly Diagnosed Childhood Diabetes type 1 - Novel Parameters of Beta Cell Destruction/Regeneration Balance and Possible Prognostic Factors of Future Disease Course. [2022]We aimed to evaluate hematopoietic stem cells (HSC) and very small embryonic-like stem cells (VSEL) mobilization to establish their role in residual beta cell function maintenance and partial remission occurrence in children newly diagnosed with type 1 diabetes.
Human umbilical cord blood cells and diabetes mellitus: recent advances. [2019]Stem cell therapy for patients with diabetes is an area of great interest to both scientists and clinicians. Human umbilical cord blood cells (HUCBCs) are being increasingly used as a source of stem cells for cell-based therapy for diabetes because these cells can differentiate into pancreatic islet β-cells. Administration of HUCBCs has been shown to lower blood glucose levels in diabetic animal models. The use of autologous HUCBC transfusion in type 1 diabetic children has not shown any benefit. However, "Stem Cell Educator" therapy has shown promise in long term lowering of blood glucose levels in both type 1 and type 2 diabetic patients. In this review, we will briefly discuss recent advances in HUCBC therapy in the treatment of diabetes and some of its complications.