What side effects are associated with this type of intervention?

Common treatments for Type 1 Diabetes include insulin therapy, continuous glucose monitoring (CGM), and insulin pump therapy. Insulin therapy can cause hypoglycemia, weight gain, and injection site reactions. CGM and insulin pumps may lead to skin irritation and discomfort at the sensor or infusion sites. Stem Cell Educator (SCE) Therapy, which uses immune modulation via cord blood stem cells, has shown potential in improving glycemic control and beta cell function without increasing the risk of serious adverse events. However, gastrointestinal symptoms have been reported as a side effect in some cases.

What prior FDA approvals exist?

FDA-approved treatments for Type 1 Diabetes that involve immune modulation include teplizumab and otelixizumab, both of which are monoclonal antibodies targeting T cells to preserve beta-cell function. Additionally, hematopoietic stem cell transplantation has been explored for its potential to reset the immune system and improve beta-cell function, although it is not yet widely adopted for T1D. These treatments share a similar goal with Stem Cell Educator (SCE) Therapy, which uses cord blood stem cells to modulate the immune system and improve beta-cell function.

What other types of research exist?

Promising alternatives to Stem Cell Educator (SCE) Therapy for Type 1 Diabetes patients include: 1) Induction of hematopoietic chimerism using mesenchymal stem cells (MSCs) and allogeneic hematopoietic stem cells (HSCs) without bone marrow recipient conditioning, and 2) Ex vivo expanded cord blood progenitor cell transplantation with a non-myeloablative conditioning regimen. Both approaches aim to achieve immune modulation and β cell regeneration.

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Stem Cell Therapy

Stem Cell Educator Therapy for Type 1 Diabetes

Phase 2 & 3

Recruiting

Research Sponsored by Throne Biotechnologies Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate venous access for apheresis

Must have a diagnosis of type 1 diabetes mellitus based on the 2015 American Diabetes Association criteria for the Clarification and Diagnosis of diabetes

Must not have

Anticoagulation other than ASA

Use of immunosuppressive medication within one month of enrollment including but not limited to prednisone, cyclosporine, tacrolimus, sirolimus, and chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Specific side effects are not listed but may include discomfort from venous access for apheresis (blood processing), potential reactions related to immune modulation, and typical risks associated with blood handling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My veins are suitable for apheresis.

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I have been diagnosed with type 1 diabetes according to the 2015 ADA criteria.

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My blood test shows I have antibodies against pancreatic cells.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on a blood thinner that is not aspirin.

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I haven't taken any immunosuppressive drugs in the last month.

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I do not have active infections like Hepatitis B, C, or HIV.

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I cannot or do not want to give permission for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment Adverse Events in T1D Subjects

Secondary study objectives

Efficacy of SCE therapy in immune modulation

Preliminary efficacy of SCE therapy to improve beta cell function

Preliminary efficacy of SCE therapy to improve glucose control

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Type 1 Diabetes (T1D) include insulin therapy, which replaces the insulin that the body can no longer produce, and adjunctive therapies that help manage blood glucose levels. Stem Cell Educator (SCE) Therapy, a more recent approach, involves immune modulation by using a patient's own immune cells 'educated' by cord blood stem cells. This therapy aims to restore immune balance and improve pancreatic function by reducing autoimmunity, which is crucial for T1D patients as it addresses the underlying cause of the disease rather than just managing symptoms. This comprehensive immune modulation can lead to improved C-peptide levels, reduced HbA1C values, and decreased insulin usage, offering a potential long-term benefit for T1D management.

Efficacy and Safety of Stem Cell Therapy for T1DM: An Updated Systematic Review and Meta-Analysis.A cluster randomised trial, cost-effectiveness analysis and psychosocial evaluation of insulin pump therapy compared with multiple injections during flexible intensive insulin therapy for type 1 diabetes: the REPOSE Trial.Moving beyond subcutaneous insulin: the application of adjunctive therapies to the treatment of type 1 diabetes.