Health TrialsbyHealthPanel

Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes

ConditionType 1 Diabetes
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age10+
SponsorThrone Biotechnologies Inc.

About this trial

Type 1 diabetes (T1D) is a T cell-mediated autoimmune disease that causes a deficit of pancreatic islet beta cells. Millions of individuals worldwide have T1D, and incidence increases annually. Several recent clinical trials point to the need for an approach that produces comprehensive immune modulation at both the local pancreatic and systemic levels. Stem Cell Educator (SCE) therapy offers comprehensive immune modulation at both the local and systemic levels in T1D by using a patient's own immune cells (including platelets) that are "educated" by cord blood stem cells. Tested clinically in more than 300 patients, SCE therapy has shown lasting reversal in autoimmunity in T1D patients, including improved C-peptide levels, reduced median glycated hemoglobin A1C (HbA1C) values, and decreased median daily usage of insulin. SCE therapy circulates a patient's blood through a blood cell separator, briefly cocultures the patient's immune cells with adherent Cord Blood Stem Cells (CB-SC) in vitro, and returns the "educated" autologous immune cells to the patient's circulation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pediatric and adult patients (>10 years).

Must have a diagnosis of type 1 diabetes mellitus based on the American Diabetes Association (ADA) Guidelines.

Must have a blood test confirming the presence of at least one autoantibody to pancreatic islet beta Cells (IAA, IA2, GAD 65, ZnT8).

Fasting C-peptide level > 0.3 ng/ml.

Disqualifiers

AST or ALT 2 > x upper limit of normal.

Abnormal bilirubin (total bilirubin > 1.2 mg/dL, direct bilirubin > 0.4 mg/dL).

Creatinine > 2.0 mg/dl.

Known coronary artery disease or EKG suggestive of coronary artery disease unless cardiac clearance for apheresis is obtained from a cardiologist.

Trial design

Design model

Single group

Treatments tested in this trial

  • Stem Cell Educator therapy

    Combination product

    Patients with T1D will be evaluated by the study principal investigator or sub-investigators. Informed consent will be obtained at the initial screen meeting. Subjects who meet all criteria will be scheduled for treatment. All enrolled subjects will receive treatment with the Stem Cell Educator (SCE) therapy consisting of a single session of mononuclear cells (MNC) collection by apheresis where peripheral blood will be processed on day 1. The MNC product will then be exposed overnight to the SCE and on day 2 the product Gleukocell will be infused intravenously back to the patient.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Treatment of T1D with Stem Cell Educator therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in fasting C-peptide levels

Change in fasting C-peptide levels at Month 3

Time frame
3 month

Secondary outcomes

1

Change in HbA1C levels

Change in HbA1C levels at Month 1 and Month 3

Time frame
3 months
2

Change daily insulin requirement

Change daily insulin requirement at Month 1 and Month 3

Time frame
3 months
3

Proportion of subjects achieving restoration of fasting C-peptide levels to the normal range

Proportion of subjects achieving restoration of fasting C-peptide levels to the normal range at Month 1 and Month 3

Time frame
3 months
4

Proportion of subjects achieving complete insulin independence

Proportion of subjects achieving complete insulin independence at Month 1 and Month 3

Time frame
3 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Throne Biotechnologies Inc.

Lead sponsor

Source ClinicalTrials.gov
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