Completed PHASE2 INTERVENTIONAL 2-arm NCT00690066

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

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

Sponsor: Juvenile Diabetes Research Foundation

Conditions Diabetes Mellitus, Insulin-Dependent Juvenile Diabetes Type 1 Diabetes Type 1 Diabetes Mellitus

Interventions PROCHYMAL® Placebo

Updated 10 times since 2017 Last updated: Mar 9, 2026 Started: Jun 11, 2008 Primary completion: Dec 12, 2010 Completion: Dec 19, 2011

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Diabetes Mellitus, Insulin-Dependent and Juvenile Diabetes and is currently completed. Juvenile Diabetes Research Foundation leads this study, which shows 10 recorded versions since 2008 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

10 versions recorded

Mar 2026 — Present [monthly]

Completed PHASE2
Sep 2024 — Mar 2026 [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Apr 2022 — Jul 2024 [monthly]

Completed PHASE2
Jan 2022 — Apr 2022 [monthly]

Completed PHASE2

▶ Show 5 earlier versions

Jan 2021 — Jan 2022 [monthly]

Completed PHASE2
Apr 2020 — Jan 2021 [monthly]

Completed PHASE2
Jun 2018 — Apr 2020 [monthly]

Completed PHASE2
Feb 2017 — Jun 2018 [monthly]

Completed PHASE2
Jan 2017 — Feb 2017 [monthly]

Completed PHASE2

First recorded

Jun 2008

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Juvenile Diabetes Research Foundation
Mesoblast, Inc.

Data source: Mesoblast, Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Bartlett, United States , Birmingham, United States , Carlisle, United States , Chapel Hill, United States , Charlotte, United States , Cincinnati, United States , Dallas, United States , Dayton, United States , Gainesville, United States , Henderson, United States and 10 more locations