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

NCT00690066 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2026-03-11

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

PROCHYMAL®

Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells

DRUG

Placebo

Intravenous infusion of excipients of PROCHYMAL®

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • Mesoblast, Inc.

    lead INDUSTRY

Principal Investigators

  • Mahboob Rahman, MD · Mesoblast, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-11
Primary Completion
2010-12-12
Completion
2011-12-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00690066 on ClinicalTrials.gov