What side effects are associated with this type of intervention?

Common side effects of stem cell therapies for Type 1 Diabetes, such as those involving Umbilical Cord-Derived Mesenchymal Stromal Cells, include immune reactions like hypersensitivity, potential infections, and complications related to cell administration. There is also a risk of adverse cell proliferation or rejection. Broader treatments like insulin therapy can cause hypoglycemia, weight gain, and injection site reactions.

What prior FDA approvals exist?

The FDA has approved several treatments for Type 1 Diabetes (T1D), primarily focusing on insulin therapy and immunomodulation. One notable approval is for clinical islet transplantation, which involves the infusion of pancreatic islet cells to restore insulin production. This method has shown safety and efficacy in clinical trials and is aimed at replacing lost β-cell function. While there are no specific FDA approvals for Umbilical Cord-Derived Mesenchymal Stromal Cells (UC-MSCs) for T1D, ongoing research is exploring their potential for immunomodulation and tissue repair, which could offer new therapeutic avenues in the future.

What other types of research exist?

Promising alternatives to UC-MSCs for Type 1 Diabetes treatment include: 1) Induced Pluripotent Stem Cells (iPSCs) which can be differentiated into insulin-producing beta cells, 2) Human Embryonic Stem Cell-Derived Pancreatic Progenitors, and 3) Encapsulated Stem Cell-Derived Beta Cells for long-term glycemic control. These alternatives have shown potential in preclinical and clinical studies for effective immunomodulation and tissue repair.

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Mesenchymal Stem Cells

Stem Cell Therapy for Type 1 Diabetes

Q: What is the mechanism of action of this treatment?

Common treatments for Type 1 Diabetes (T1D) include insulin therapy, which replaces the insulin that the body can no longer produce, and immunomodulatory therapies that aim to preserve or restore beta-cell function. Treatments like Umbilical Cord-Derived Mesenchymal Stromal Cells (UC-MSCs) are being studied for their potential to modulate the immune system and repair tissue. UC-MSCs may help prevent the immune system from attacking insulin-producing beta cells and promote tissue regeneration, which could preserve or restore the body's ability to produce insulin. This is crucial for T1D patients as it addresses the root cause of the disease and could reduce the need for lifelong insulin therapy.

Phase 1

Recruiting

Led By Hongjun Wang, PhD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

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

Must have

Positivity for at least one T1D-associated autoantibody, such as GAD, IA-2 or ZnT8 autoantibodies

Male and female between the ages of 18 and 30

Must not have

Subjects with HgbA1c >12%, and/or fasting blood glucose >270 mg/dL and/or frequent episodes of hypoglycemia (>2 episodes per week of blood glucose levels <60 mg/dL)

Subject is being treated for severe active infection of any type

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over the course of 1 year (0, 1, 3, 6, 12 months)

Summary

This trial is testing if special cells from umbilical cords can help young adults with Type 1 diabetes by calming their immune system and reducing inflammation. These cells pose a lesser risk of viral contamination due to low placental transmission during prenatal life.

Who is the study for?

This trial is for individuals aged 18-30 recently diagnosed with Type 1 Diabetes, having some remaining insulin-producing cell function and positive for specific diabetes-related autoantibodies. They must be mentally stable, able to manage their diabetes intensively, and have normal blood counts and liver function. Excluded are those with severe infections, certain eye diseases, extreme body weights, high blood pressure or lipids, pregnancy or intent to become pregnant during the study.

What is being tested?

The trial is testing the safety and effectiveness of using umbilical cord-derived mesenchymal stem cells (UC-MSCs) compared to a placebo in treating new-onset Type 1 Diabetes. The aim is to see if these cells can help manage the disease by preserving insulin production.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include immune reactions since MSCs are involved; however this will be closely monitored as part of assessing the treatment's safety.

Eligibility Criteria

Inclusion Criteria

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

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I have antibodies linked to type 1 diabetes.

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I am between 18 and 30 years old.

Exclusion Criteria

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

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My blood sugar levels are very high or I often have very low blood sugar.

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I am currently being treated for a severe infection.

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My LDL cholesterol or triglycerides are more than three times the normal limit.

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I do not have severe health issues unrelated to diabetes.

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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

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I have been diagnosed with cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over the course of 1 year (0, 1, 3, 6, 12 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~over the course of 1 year (0, 1, 3, 6, 12 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and over the course of 1 year (0, 1, 3, 6, 12 months) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

12 month Change in C-peptide area under the curve after a 2-hour MMTT

Secondary study objectives

1 year peak C-peptide after a 2-hour MMTT

6 Month Change in C-Peptide area under the curve after a 2-hour MMTT

6 Month peak C-peptide after a 2-hour MMTT

+1 more

Other study objectives

Change in autoantigen specific T-cell response

Change in beta cell death measurements

Change in blood T-reg number and function

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group A TreatmentExperimental Treatment1 Intervention

2.5 x 10\^6 MSC per kg will be infused intravenously on Day 1

Group II: Group B PlaceboPlacebo Group1 Intervention

Plasmalyte with 0.5% Human Serum Albumin will be infused intravenously on Day 1

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mesenchymal Stem Cells (MSCs)

2017

Completed Phase 2

~50

0 / 8Eligibility 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 immunomodulatory therapies that aim to preserve or restore beta-cell function. Treatments like Umbilical Cord-Derived Mesenchymal Stromal Cells (UC-MSCs) are being studied for their potential to modulate the immune system and repair tissue. UC-MSCs may help prevent the immune system from attacking insulin-producing beta cells and promote tissue regeneration, which could preserve or restore the body's ability to produce insulin. This is crucial for T1D patients as it addresses the root cause of the disease and could reduce the need for lifelong insulin therapy.

Current progress in stem cell therapy for type 1 diabetes mellitus.Mesenchymal stromal cells to halt the progression of type 1 diabetes?