Stem Cell Educator therapy for Diabetes Mellitus
Phase-Based Progress Estimates
Effectiveness
Safety
Diabetes Mellitus+2 More
Stem Cell Educator therapy - CombinationProductEligibility
Any Age
All Sexes
What conditions do you have?
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Eligibility
Any Age
All Sexes
What conditions do you have?
Select
Study Summary
This trial uses a patient's own immune cells that are "educated" by cord blood stem cells in order to improveC-peptide levels, reduce median glycated hemoglobin A1C (HbA1C) values, and decrease median daily usage of insulin in Type 1 diabetes (T1D) patients.
Eligible Conditions
- Diabetes Mellitus
- Type 1 Diabetes Mellitus
Treatment Effectiveness
Effectiveness Progress
Other trials for Diabetes Mellitus
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: 12 month
12 month
Efficacy of SCE therapy in immune modulation
12 months
Preliminary efficacy of SCE therapy to improve beta cell function
Preliminary efficacy of SCE therapy to improve glucose control
Insulin
6 month
Incidence of Treatment Adverse Events in T1D Subjects
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Other trials for Diabetes Mellitus
Trial Design
2 Treatment Groups
Treatment of T1D with Stem Cell Educator therapy
1 of 2
Conventional insulin therapy
1 of 2
Experimental Treatment
50 Total Participants · 2 Treatment Groups
Primary Treatment: Stem Cell Educator therapy · No Placebo Group · Phase 2 & 3
Treatment of T1D with Stem Cell Educator therapy
CombinationProduct
Experimental Group · 1 Intervention: Stem Cell Educator therapy · Intervention Types: CombinationProductConventional insulin therapy
CombinationProduct
Experimental Group · 1 Intervention: Stem Cell Educator therapy · Intervention Types: CombinationProductTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 month
Who is running the clinical trial?
Hackensack Meridian HealthOTHER
110 Previous Clinical Trials
23,547 Total Patients Enrolled
2 Trials studying Diabetes Mellitus
59 Patients Enrolled for Diabetes Mellitus
Throne Biotechnologies Inc.Lead Sponsor
6 Previous Clinical Trials
290 Total Patients Enrolled
3 Trials studying Diabetes Mellitus
220 Patients Enrolled for Diabetes Mellitus
YONG ZHAO, MD,PhDStudy ChairThrone Biotechnologies Inc.
Eligibility Criteria
Age Any Age · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:is important, but one's ability to provide meaningful consent may be compromised if he or she is incapacitated
The study is only for female patients who are willing to use birth control that is recommended by the FDA until 6 months after treatment.
If a person's HbA1C is less than 10% at enrollment, they are likely to have good blood sugar control.
A continuous glucose monitoring system (CGMS) is required in order to participate in this study.
The person must have diabetes mellitus that is type 1 in nature and was diagnosed using the 2015 American Diabetes Association criteria.
The person must have a blood test confirming the presence of at least one autoantibody to pancreatic islet cells
is a prerequisite for a successful procedure
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
Who else is applying?
What state do they live in?
| Texas | 25.0% |
| New York | 25.0% |
| Florida | 25.0% |
| Other | 25.0% |
How old are they?
| 18 - 65 | 66.7% |
| < 18 | 33.3% |
What site did they apply to?
| Hackensack Meridian Health | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 40.0% |
| Did not meet criteria | 60.0% |
How many prior treatments have patients received?
| 0 | 100.0% |
References
- Zhao, Yong, Zhaoshun Jiang, Tingbao Zhao, Mingliang Ye, Chengjin Hu, Zhaohui Yin, Heng Li, et al.. 2012. “Reversal of Type 1 Diabetes via Islet Β Cell Regeneration Following Immune Modulation by Cord Blood-derived Multipotent Stem Cells”. BMC Medicine. Springer Science and Business Media LLC. doi:10.1186/1741-7015-10-3.
- Zhao, Yong. 2012. “Stem Cell Educator Therapy and Induction of Immune Balance”. Current Diabetes Reports. Springer Science and Business Media LLC. doi:10.1007/s11892-012-0308-1.
- Delgado, Elias, Marcos Perez-Basterrechea, Beatriz Suarez-Alvarez, Huimin Zhou, Eva Martinez Revuelta, Jose Maria Garcia-Gala, Silvia Perez, et al.. 2015. “Modulation of Autoimmune T-cell Memory by Stem Cell Educator Therapy: Phase 1/2 Clinical Trial”. Ebiomedicine. Elsevier BV. doi:10.1016/j.ebiom.2015.11.003.
- Zhao, Yong, Zhaoshun Jiang, Elias Delgado, Heng Li, Huimin Zhou, Wei Hu, Marcos Perez-Basterrechea, et al.. 2017. “Platelet-derived Mitochondria Display Embryonic Stem Cell Markers and Improve Pancreatic Islet Β-cell Function in Humans”. Stem Cells Translational Medicine. Oxford University Press (OUP). doi:10.1002/sctm.17-0078.
- Zhao, Yong, Colette M. Knight, Zhaoshun Jiang, Elias Delgado, Anne Marie Van Hoven, Steven Ghanny, Zhiguang Zhou, et al.. 2022. “Stem Cell Educator Therapy in Type 1 Diabetes: From the Bench to Clinical Trials”. Autoimmunity Reviews. Elsevier BV. doi:10.1016/j.autrev.2022.103058.
- 2022. "Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04011020.
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