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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 12

Awards & highlights

Study Summary

This trial will test if a new treatment for Type I Diabetes Mellitus (T1DM) is safe and effective. The treatment involves using the patient's own cells to create immunoregulatory dendritic cells (iDC). These iDC will be treated with antisense DNA and then injected back into the patient. The goal is to see if this treatment will safely preserve and/or increase B-cell mass, resulting in better blood sugar control.

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.Check my eligibility

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.See study design

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 agree to use effective birth control during the study.

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I was diagnosed with type 1 diabetes within the last 6 months and meet the age requirement.

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I have diabetes-related antibodies in my blood.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 12

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The incidence of treatment-emergent adverse events.

Secondary outcome measures

2-hour area under the curve (AUC) average of C-peptide at 12 months after completion of administration of assigned therapy (Protocol Month 15).

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

0 / 5Eligibility criteria met

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

Diabetes Management Research Study Groups: iDC recipients, Control DC recipients, Placebo recipients

Diabetes Management 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are those below 45 years of age permitted to participate in this medical experiment?

"As per the enrollment requirements, this clinical trial accepts patients between 12 and 35 years of age."

Answered by AI

Are there still vacancies for participants in this research project?

"Confirmed. Clinicaltrials.gov shows that this exploration, which was first advertised on October 1st 2013 and then updated last on the 22nd of October in the same year, is not accepting applications currently. Despite this circumstance, there are 1250 separate trials actively recruiting at present."

Answered by AI

What criteria must participants meet in order to be eligible for this clinical experiment?

"For this clinical trial, 90 individuals aged between 12 and 35 with newly diagnosed diabetes or an autoimmune disorder need to be recruited. To take part in the study, patients must have been diagnosed within 6 months of recruitment and their age should correspond to one of several tiers: 18+ for phase IB; 16-18 for 10 subjects; 12-16 for another 10 participants; 8-12 for a third group of 10 people; and finally under 8 years old for any remaining phase IIA enrollees."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dendritic Cells for Type 1 Diabetes Mellitus (T1DM) Therapy

2013. "Dendritic Cells for Type 1 Diabetes Mellitus (T1DM) Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01947569.

All > Gestational Diabetes > Type 1 Diabetes