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Could stem cells help newly diagnosed type 1 diabetes patients?

NCT ID NCT00690066

Disease control Sponsor: Mesoblast, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested whether infusions of PROCHYMAL, a stem cell product, could safely help people recently diagnosed with type 1 diabetes. The study enrolled 63 participants aged 12–35 who had been diagnosed within the past 20 weeks. Researchers measured how well the pancreas still made insulin and tracked daily insulin use and blood sugar control.

What this could mean

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

Active substance
PROCHYMAL (adult stem cells from bone marrow)
What this could lead to
If it works, this could help people with new-onset type 1 diabetes keep making some of their own insulin, reducing daily insulin shots.
What could go wrong
This is a small, early-phase trial (63 people). Stem cell treatments are complex and may not work for everyone. Risks include infusion reactions or no benefit over placebo.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

63 people

The number who actually took part.

Started

Jun 2008

Finished

Dec 2011

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

12 to 35 years

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: * Participant must have a diagnosis of type 1 diabetes mellitus based on the American Diabetes Association (ADA) criteria. * Participant must be screened between 2 and 20 weeks from initial T1DM diagnosis * Participants must be between the ages of 12 and 35 (inclusive). * Participant must have at least one diabetes-related autoantibody present (either GAD or IA-2). * Participant must have some beta cell function as determined by C-peptide testing (at least 0.2 pmol/mL (0.6 ng/mL) during MMTT. * Participants must be willing to comply with "intensive diabetes management" as directed by the Investigator with the goal of maintaining blood glucose as close to normal as possible (i.e., glycosylated hemoglobin A1c (HbA1c) value of ≤ 7.0%). * Participants must be willing to comply with the schedule of study visits and protocol requirements. Exclusion Criteria: * Participant has Body Mass Index (BMI) ≥ 30. * Participant has evidence of retinopathy at baseline. * Participant has abnormally high lipid levels. * Participant has abnormal blood pressure. * Participant has an abnormal serum creatinine. * Participant has evidence of clinically significant proteinuria. * Participant has diabetic ketoacidosis. * Participant is being treated for a severe active infection of any type. * A female participant who is breast-feeding, pregnant, or intends to become pregnant during the study. * Participant with clinically relevant uncontrolled medical condition not associated with diabetes (e.g. hematologic, renal, hepatic, neurologic, cardiac, or respiratory). * Participant has received an investigational drug (not approved by the FDA) for any indication 30 days prior to the screening visit. * Participant is allergic to bovine or porcine products. * Participant has evidence of active malignancy or prior history of active malignancy that has not been in remission for at least 5 years. * Participant has any medical condition, which in the opinion of the Investigator, rendered his/her participation in this study unsuitable.

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Conditions

The condition(s) this trial relates to.

Insulin Resistance 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, insulin-dependent Juvenile diabetes Type 1 diabetes Type 1 diabetes mellitus

Contacts and locations

Locations

  • AM Diabetes & Endocrinology Center

    Bartlett, Tennessee, 38133, United States

  • American Health Research, Inc.

    Charlotte, North Carolina, 28207, United States

  • Clinical and Transitional Science Institute

    Milwaukee, Wisconsin, 53226, United States

  • Cumberland Valley Endocrinology

    Carlisle, Pennsylvania, 17015, United States

  • Desert Endocrinology CRC

    Henderson, Nevada, 89052, United States

  • Diabetes Research Institute

    Miami, Florida, 33136, United States

  • Nevada Alliance Against Diabetes

    Las Vegas, Nevada, 89101, United States

  • Optimum Clinical Research, Inc.

    Salt Lake City, Utah, 84102, United States

  • Providence Health Partners - Center for Clinical Research

    Dayton, Ohio, 45439, United States

  • Scripps Whittier Diabetes Institute

    La Jolla, California, 92037, United States

  • Stanford University

    Stanford, California, 94305, United States

  • The Lindner Clinical Trial Center

    Cincinnati, Ohio, 45219, United States

  • The Strelitz Diabetes Center, Eastern VA Medical School

    Norfolk, Virginia, 23510, United States

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Alabama, Division of Endocrinology & Metabolism

    Birmingham, Alabama, 35294, United States

  • University of Florida

    Gainesville, Florida, 32610, United States

  • University of Kentucky

    Lexington, Kentucky, 40502, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of North Carolina Diabetes Care Center

    Chapel Hill, North Carolina, 27599, United States

  • University of Wisconsin Health- West Clinic

    Madison, Wisconsin, 53717, United States

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