Stem Cell Educator Therapy for Type 1 Diabetes

Recruiting at 1 trial location

Overseen By Boris Veysman, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Throne Biotechnologies Inc.

Must not be taking: Immunosuppressants, Chemotherapy, Anticoagulants

Disqualifiers: Coronary artery disease, Active infection, Autoimmune diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

50 Participants Needed

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 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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

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. ^{1 2 3 6 8}

Research Team

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.

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.

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

Group I: Treatment of T1D with Stem Cell Educator therapy Experimental Treatment 1 Intervention

Recruited T1D subjects will receive one treatment with SCE therapy.

Group II: Conventional insulin therapy Experimental Treatment 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stem cell therapy for type 1 diabetes mellitus: a review of recent clinical trials. Couri, CE., Voltarelli, JC.[2021]

Stem cell therapy (SCT) using autologous adipose-derived insulin-secreting mesenchymal stromal cells (IS-AD-MSC) combined with bone marrow-derived hematopoietic stem cells (BM-HSC) is a safe treatment for type 1 diabetes mellitus (T1DM), showing sustained improvements in blood sugar control without adverse effects in a study of 20 patients.

The autologous SCT group demonstrated better long-term glycemic control compared to the allogenic SCT group, indicating that using a patient's own cells may be more effective for managing T1DM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin-secreting adipose-derived mesenchymal stromal cells with bone marrow-derived hematopoietic stem cells from autologous and allogenic sources for type 1 diabetes mellitus. Thakkar, UG., Trivedi, HL., Vanikar, AV., et al.[2022]

The Stem Cell Educator therapy, which uses cord blood-derived multipotent stem cells to modulate the immune system, has shown promising results in reversing autoimmunity in patients with long-standing Type 1 diabetes (T1D).

In a clinical trial, a single treatment led to the regeneration of pancreatic islet β cells and improved metabolic control, highlighting a potential new approach to treating T1D that differs from conventional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stem cell educator therapy and induction of immune balance. Zhao, Y.[2021]

Stem cell transplantation (SCT) significantly reduces HbA1c levels and improves C-peptide levels in patients with type 1 diabetes (T1DM), based on a meta-analysis of 29 studies involving 487 patients.

SCT shows promising safety with a mortality rate of 3.4%, and the transient insulin independence rate was 9.6 per 100 person-years, indicating potential for improved metabolic control in T1DM patients, especially with specific stem cell combinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of stem cells transplantation in patients with type 1 diabetes mellitus-a systematic review and meta-analysis. Wu, Q., Zheng, S., Qin, Y., et al.[2021]

In a study of 59 children with newly diagnosed type 1 diabetes, those with higher levels of very small embryonic-like stem cells (VSEL) and a higher VSEL/HSC ratio showed better maintenance of beta cell function, as indicated by stimulated C-peptide secretion.

Lower levels of hematopoietic stem cells (HSC) at diagnosis were associated with a greater likelihood of achieving partial remission within the first 3 to 6 months, suggesting that HSC and VSEL may play important roles in preserving beta cell function in type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Jamiołkowska-Sztabkowska, M., Grubczak, K., Starosz, A., et al.[2022]

Human umbilical cord blood cells (HUCBCs) can differentiate into pancreatic islet β-cells and have been effective in lowering blood glucose levels in diabetic animal models, indicating their potential for diabetes treatment.

While autologous HUCBC transfusions in type 1 diabetic children have not shown benefits, 'Stem Cell Educator' therapy has demonstrated promise in achieving long-term blood glucose control in both type 1 and type 2 diabetes patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human umbilical cord blood cells and diabetes mellitus: recent advances. Reddi, AS., Kothari, N., Kuppasani, K., et al.[2019]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Stem Cell Educator therapy in type 1 diabetes: From the bench to clinical trials. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Stem cell therapy for type 1 diabetes mellitus: a review of recent clinical trials. [2021]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. United States pubmed.ncbi.nlm.nih.gov

Stem cell educator therapy and induction of immune balance. [2021]

6. Japan pubmed.ncbi.nlm.nih.gov

Efficacy and safety of stem cells transplantation in patients with type 1 diabetes mellitus-a systematic review and meta-analysis. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

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 Emirates pubmed.ncbi.nlm.nih.gov

Human umbilical cord blood cells and diabetes mellitus: recent advances. [2019]