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Dendritic Cell Therapy

Dendritic Cell Therapy for Type 1 Diabetes

Phase 1 & 2
Waitlist Available
Research Sponsored by DiaVacs, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Evidence of at least one high-risk HLA haplotype
Normal hematologic, liver and kidney function
Must not have
No prior radiation therapy, immunotherapy, or chemotherapy
A hemaglobinopathy known to interfere with the ability to accurately determine HbA1c
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial tests if using a patient's own modified immune cells can help protect and improve insulin-producing cells in people who have been diagnosed with Type I Diabetes. The goal is to see if this can help control blood sugar levels better.

Who is the study for?
This trial is for new onset Type 1 Diabetes Mellitus patients over 18 years old (with age limits decreasing as the trial progresses). Participants must have specific genetic markers, one diabetes-related autoantibody, normal organ function, and agree to use effective birth control. Excluded are those with impaired kidney function, on certain therapies or drugs that affect the immune system or glucose regulation, pregnant women, and individuals with other significant health issues.
What is being tested?
The study tests engineered dendritic cells designed to improve beta cell mass in Type 1 Diabetes patients. Phase IB focuses on safety while Phase IIA compares three groups for both safety and effectiveness in preserving/increasing beta cell mass and improving blood sugar levels.
What are the potential side effects?
As this is an early-phase trial primarily assessing safety, potential side effects aren't specified but may include typical immune response reactions such as inflammation at injection sites or flu-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a high-risk HLA type.
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My blood, liver, and kidney tests are normal.
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I have diabetes-related antibodies in my blood.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had radiation, immunotherapy, or chemotherapy before.
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I have a blood condition that affects HbA1c test accuracy.
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I do not have immune disorders like autoimmune diseases or HIV/HBV/HCV/HPV/HSV.
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I am currently on antibiotics for an infection.
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I have a history of serious heart conditions or uncontrolled high blood pressure.
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I need to take corticosteroids regularly.
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My creatinine level is above 1.5, indicating kidney issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: iDC recipientsExperimental Treatment1 Intervention
iDC cells modified by in vitro engineering.
Group II: Control DC recipientsActive Control1 Intervention
DC cells which have not been modified.
Group III: Placebo recipientsPlacebo Group1 Intervention
Saline injections.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biological
2020
Completed Phase 2
~200

Find a Location

Who is running the clinical trial?

DiaVacs, Inc.Lead Sponsor
1 Previous Clinical Trials

Media Library

Autologous, ex vivo-engineered, co-stimulation impaired dendritic cells (Dendritic Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01947569 — Phase 1 & 2
Insulin-dependent diabetes Research Study Groups: iDC recipients, Control DC recipients, Placebo recipients
Insulin-dependent diabetes Clinical Trial 2023: Autologous, ex vivo-engineered, co-stimulation impaired dendritic cells Highlights & Side Effects. Trial Name: NCT01947569 — Phase 1 & 2
Autologous, ex vivo-engineered, co-stimulation impaired dendritic cells (Dendritic Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01947569 — Phase 1 & 2
~7 spots leftby Dec 2025
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