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Stem Cell Educator Therapy

Phase 1

Diabetes Mellitus Type 1 | Monoclonal antibody | Metabolic |Meridian Bioscience Inc|Last Updated: Apr 3, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment13

FDA Designations

No designations recorded

Clinical trial landscape

Stem Cell Educator Therapy · 1 trial · 1 indication

Phase 1 1
NCT02624804A Pilot Study of the Therapeutic Potential of Stem Cell Educator Therapy in Type 1 DiabetesDiabetes Mellitus Type 1
COMPLETED13 Analytics
PHASE1COMPLETED
A Pilot Study of the Therapeutic Potential of Stem Cell Educator Therapy in Type 1 Diabetes
Diabetes Mellitus Type 1Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Treatment Related Adverse Events
12 months

The primary study endpoint will be the occurrence of treatment-related adverse effects. Adverse events that occur during therapy (especially those that necessitate temporary or permanent discontinuation of therapy) and over the 12-month follow-up period will be assessed.

Secondary Endpoints

Number of Patients Unable to Complete Therapy
One week
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Stem Cell Educator TherapyEXPERIMENTALPatients will have apheresis performed and then have their own blood returned to them with the "educated" lymphocytes

Interventions

NameTypeDescription
Stem Cell Educator TherapyBIOLOGICALPatients will receive apheresis and then have their own blood returned to them with the "educated" lymphocytes
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Adult patients \>/=18 years * 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 have a blood test confirming the presence of at least one autoantibody to pancreatic ...

Countries:United States
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Frequently asked questions about Stem Cell Educator Therapy

What is Stem Cell Educator Therapy used for?

Stem Cell Educator Therapy is an investigational therapy being studied for the treatment of Diabetes Mellitus Type 1. It is currently in Phase 1 clinical development and has not been approved by the FDA. The therapy is intended to address the underlying autoimmune process in type 1 diabetes.

Who is developing Stem Cell Educator Therapy?

Stem Cell Educator Therapy is being developed by Meridian Bioscience Inc, which trades under the ticker VIVO. The company is conducting clinical research to evaluate the therapy's potential in treating type 1 diabetes.

What phase is Stem Cell Educator Therapy in?

Stem Cell Educator Therapy is in Phase 1 clinical development. It is an investigational therapy and has not received FDA approval. The therapy is being studied for its safety and potential efficacy in patients with type 1 diabetes.

What clinical trials is Stem Cell Educator Therapy in?

Stem Cell Educator Therapy has one completed clinical trial, identified as NCT02624804. This Phase 1 study, titled 'A Pilot Study of the Therapeutic Potential of Stem Cell Educator Therapy in Type 1 Diabetes,' enrolled 13 participants in the United States. The trial was uncontrolled and not randomized.

Is Stem Cell Educator Therapy a monoclonal antibody?

Yes, Stem Cell Educator Therapy is classified as a monoclonal antibody modality. It is being investigated as a potential treatment for type 1 diabetes, with a focus on modulating the immune system to address the disease.