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NCT04011020RECRUITINGIRB Ready

Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes

Sponsored by Throne Biotechnologies Inc.

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
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1 of 50 participants interested
2% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

Adult patients ( 14 years) 2. Must have a diagnosis of type 1 diabetes mellitus based on the 2015 American Diabetes Association criteria for the Clarification and Diagnosis of diabetes. 3. Must have a blood test confirming the presence of at least one autoantibody to pancreatic islet Cells (IAA, IA2, GAD 65, ZnT8). 4. Fasting C-peptide level \> 0.3 ng/ml 5. HbA1C \< 10% at enrollment 6. Recent diagnosis (within two years of enrollment) 7. Adequate venous access for apheresis 8. Must be equipped with a continuous glucose monitoring system (CGMS) 9. Ability to provide informed consent 10. For female patients only, willingness to use FDA-recommended birth control (http://www.fda.gov/downloads/ForConsumers/ByAudience/ForWomen/FreePublications/UCM356451.pdf) until 6 months post treatment. 11. Must agree to comply with all study requirements and be willing to complete all study visits

Exclusion Criteria

AST or ALT 2 \> x upper limit of normal. 2. Abnormal biliru

❓ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

50 participants

Gender

ALL

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Sponsor

Throne Biotechnologies Inc.

Study Locations

Choose your preferred location or select flexible during enrollment

ACTIVE_NOT_RECRUITING

Hackensack

New Jersey

Location available
RECRUITING

Paramus

New Jersey

Location available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

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Looking for Type 1 Diabetes Treatment in Hackensack?

Join others in New Jersey exploring innovative treatment options through clinical research

Type 1 Diabetes Treatment Options in Hackensack, New Jersey

If you're searching for Type 1 Diabetes treatment in Hackensack, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Hackensack, Paramus and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Type 1 Diabetes. All study-related care is provided at no cost to participants.

Local Sites
2 locations in New Jersey
Now Enrolling
Up to 50 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Type 1 Diabetes?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Type 1 Diabetes

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Type 1 Diabetes Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT04011020. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.