50 Participants Needed

Stem Cell Educator Therapy for Type 1 Diabetes

Recruiting at 1 trial location
YZ
BV
Overseen ByBoris Veysman, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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.12345

What 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.12467

Is 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.12458

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.

Research Team

YZ

YONG ZHAO, MD,PhD

Principal Investigator

Throne Biotechnologies Inc.

Eligibility 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.
See 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.
See 9 more

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

Treatment Details

Interventions

  • Stem Cell Educator Therapy
Trial Overview 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.
Participant Groups
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

Who Is Running the Clinical Trial?

Throne Biotechnologies Inc.

Lead Sponsor

Trials
7
Recruited
340+

Hackensack Meridian Health

Collaborator

Trials
141
Recruited
42,900+

Findings from Research

Stem Cell Educator™ therapy, which uses human cord-blood-derived multipotent stem cells, has shown clinical safety and efficacy in treating Type 1 diabetes (T1D) and other autoimmune diseases through immune education.
This novel approach not only targets the islet β cells but also aims to protect the islet nervous system, potentially restoring normal islet function and offering a safer alternative to traditional immune therapies.
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.Zhao, Y., Veysman, B.[2023]
Stem Cell Educator therapy, developed using cord-blood-derived multipotent stem cells, has shown clinical safety and efficacy in treating Type 1 diabetes (T1D) through international multi-center studies over the past 10 years.
This therapy works by correcting autoimmunity and inducing immune tolerance through various mechanisms, including T-cell modulation and suppression of activated B cells, making it a promising option for restoring pancreatic β-cell function in T1D patients.
Stem Cell Educator therapy in type 1 diabetes: From the bench to clinical trials.Zhao, Y., Knight, CM., Jiang, Z., et al.[2022]
Stem cell therapy shows promise for treating type 1 diabetes by potentially regenerating beta cells and preserving insulin production, with clinical trials ongoing since 2003 in various countries.
The Diabetes Control and Complications Trial (DCCT) highlighted that higher C-peptide levels, which indicate better insulin secretion, are associated with a lower risk of chronic complications in type 1 diabetes, emphasizing the importance of beta cell preservation in treatment strategies.
Stem cell therapy for type 1 diabetes mellitus: a review of recent clinical trials.Couri, CE., Voltarelli, JC.[2021]

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]
Stem Cell Educator therapy in type 1 diabetes: From the bench to clinical trials. [2022]
Stem cell therapy for type 1 diabetes mellitus: a review of recent clinical trials. [2021]
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 educator therapy and induction of immune balance. [2021]
Efficacy and safety of stem cells transplantation in patients with type 1 diabetes mellitus-a systematic review and meta-analysis. [2021]
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]
8.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Human umbilical cord blood cells and diabetes mellitus: recent advances. [2019]
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