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Could a stem cell 'Education' help tame type 1 diabetes?

NCT ID NCT02624804

Disease control Sponsor: Hackensack Meridian Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study tested a new approach called Stem Cell Educator therapy in 13 adults with type 1 diabetes. The treatment involves taking a patient's own blood cells, processing them with stem cells, and returning them to the body. The main goal was to see if it is safe and feasible, with a focus on side effects and whether patients could complete the therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Stem Cell Educator therapy (a process where a patient's own blood cells are treated outside the body and returned)
What this could lead to
If it works, this could point toward a way to help the body better manage type 1 diabetes without needing as much insulin.
What could go wrong
This is a very early, small pilot study with only 13 people. It mainly looks at safety, not whether it truly controls diabetes long-term. The therapy may not work or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

13 people

The number who actually took part.

Started

Jun 2017

Finished

Mar 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 islet cells (IAA, IA2, GAD 65, ZnT8) * Fasting C-peptide level \> 0.3 ng/ml * Adequate venous access for apheresis * Ability to provide informed consent * 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. * 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. * Known active infection * Pregnancy or breastfeeding mothers * Use of immunosuppressive medication within one month of enrollment including but not limited to prednisone, cyclosporine, tacrolimus, sirolimus, and chemotherapy. * Presence of any other autoimmune diseases (lupus, rheumatoid arthritis, scleroderma, etc.) * Anticoagulation other than ASA. * Hemoglobin \< 10 g/dl or platelets \< 100 k/ml * Is unable or unwilling to provide informed consent * Presence of any other physical or psychological medical condition that, in the opinion of the investigator, would preclude participation

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Conditions

The condition(s) this trial relates to.

diabetes mellitus type 1 diabetes mellitus type 1 diabetes mellitus 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus, type 1

Contacts and locations

Locations

  • Hackensack University Medical Center - John Theurer Cancer Center

    Hackensack, New Jersey, 07601, United States

More trials for these conditions

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