AzTrials
AzTrials

Type 1 Diabetes MellitusPhase 2NCT00690066

PROCHYMAL® (Human Adult Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus (T1DM)

A Phase 2 study testing PROCHYMAL® in people with Type 1 Diabetes Mellitus and Type 1 Diabetes, run by Mesoblast, Inc. at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to establish the safety and efficacy of multiple administrations of PROCHYMAL® in participants recently diagnosed with type 1 diabetes mellitus. Read more about this study

Who is it for?
Ages 12 to 35 years
What is being tested?
PROCHYMAL®
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
63 participants
Where
20 sitesUnited States
Study dates
11 Jun 2008to 19 Dec 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 35 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • AM Diabetes & Endocrinology Center

    Bartlett, Tennessee, 38133

  • University of Alabama, Division of Endocrinology & Metabolism

    Birmingham, Alabama, 35294

  • Cumberland Valley Endocrinology

    Carlisle, Pennsylvania, 17015

  • University of North Carolina Diabetes Care Center

    Chapel Hill, North Carolina, 27599

  • American Health Research, Inc.

    Charlotte, North Carolina, 28207

  • The Lindner Clinical Trial Center

    Cincinnati, Ohio, 45219

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Providence Health Partners - Center for Clinical Research

    Dayton, Ohio, 45439

  • University of Florida

    Gainesville, Florida, 32610

  • Desert Endocrinology CRC

    Henderson, Nevada, 89052

  • Scripps Whittier Diabetes Institute

    La Jolla, California, 92037

  • Nevada Alliance Against Diabetes

    Las Vegas, Nevada, 89101

  • University of Kentucky

    Lexington, Kentucky, 40502

  • University of Wisconsin Health- West Clinic

    Madison, Wisconsin, 53717

  • Diabetes Research Institute

    Miami, Florida, 33136

  • Clinical and Transitional Science Institute

    Milwaukee, Wisconsin, 53226

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • The Strelitz Diabetes Center, Eastern VA Medical School

    Norfolk, Virginia, 23510

  • Optimum Clinical Research, Inc.

    Salt Lake City, Utah, 84102

  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

Official title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of PROCHYMAL® (Ex Vivo Cultured Adult Human Mesenchymal Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus

The purpose of this study is to establish the safety and efficacy of multiple administrations of PROCHYMAL® in participants recently diagnosed with type 1 diabetes mellitus.

Read the detailed description

Diabetes mellitus refers to disorders in which the body has trouble controlling its blood glucose levels. There are two main types of diabetes: type 1 and type 2. Type 1 diabetes mellitus (T1DM), which is being studied in this trial, is an autoimmune disorder in which the body's own immune system attacks and destroys the cells that make insulin. These cells are called beta cells. As beta cells are destroyed, less insulin can be made. This causes blood sugar levels to increase above normal and can cause life-threatening hypo- and hyper-glycemic reactions. For this reason, people with type 1 diabetes must take insulin to help control their blood sugar levels. Over time, poorly controlled diabetes can lead to a variety of serious health conditions, including heart disease, stroke, blindness, amputations, kidney disease, and nerve damage. Insulin is the primary method of controlling diabetes by regulating blood glucose levels, but it may not reverse or prevent disease progression. The active ingredient in PROCHYMAL® is adult human mesenchymal stem cells (MSCs). MSCs have been shown to interact with the immune cells in the body, reducing inflammation and assisting in tissue repair. This study will help determine whether MSCs can protect normal pancreatic tissue from autoimmune attack and repair damaged pancreatic tissue, leading to an increase in insulin production and decrease in circulating blood glucose. The characteristics and biologic activity of PROCHYMAL®, along with a good safety profile in human trials to date, suggest that PROCHYMAL® may be a good candidate for addressing Type 1 Diabetes.

Being tested
PROCHYMAL®, Placebo
Keywords
T1DM, Type 1 Diabetes Mellitus, Type 1 Diabetes, Diabetes Mellitus, Insulin-Dependent, Juvenile Diabetes, Adult Human Stem Cells, Mesenchymal Stem Cells, MSCs, Insulin, Osiris, Prochymal
Medical subject headings
Diabetes Mellitus, Type 1, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PROCHYMAL®Drug

    Also called ex vivo cultured adult human mesenchymal stem cells, Prochymal

    Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells

  • PlaceboDrug

    Intravenous infusion of excipients of PROCHYMAL®

Study groups in NCT00690066
Study groupRoleWhat they receive
ProchymalExperimentalPROCHYMAL®
Receives: Drug: PROCHYMAL®
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. C-peptide area under the concentration curve (AUC) response (MMTT)

    Measured: 1 year

Secondary outcomes (6)

  1. Peak C-peptide response (MMTT)

    Measured: 2 years

  2. Basal C-peptide response

    Measured: 2 years

  3. Total daily insulin dose (units/kg)

    Measured: 2 years

  4. Glycosylated hemoglobin (HbA1c) levels

    Measured: 2 years

  5. Number of severe and documented hypoglycemic events

    Measured: 2 years

  6. Changes in levels of glutamic acid decarboxylase (GAD) or islet antigen 2 (IA-2) autoantibodies

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2008 (estimated)
  2. Study start11 Jun 2008
  3. Primary completion12 Dec 2010
  4. Study completion19 Dec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00690066
Sponsor's protocol ID
901
Status last verified
Nov 2025
First submitted
2 Jun 2008
Last updated
11 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PROCHYMAL® in people with Type 1 Diabetes Mellitus and Type 1 Diabetes, run by Mesoblast, Inc. at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

C-peptide area under the concentration curve (AUC) response (MMTT) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00690066.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in