Clinical Study Details

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 (T1DM)-Protocol No 901

Description

The goal of this study is to learn if a if infusions of mesenchymal stem cells can help people with newly diagnosed type 1 diabetes by delaying or stopping further destruction of the cells in the body that make insulin. We will follow people in the study by performing blood tests and will collect information about their diabetes management to learn whether these cells works when given to people with newly diagnosed type 1 diabetes.

Eligibility

Eligible participants need to be:

• Diagnosed with type 1 diabetes in the last 20 weeks
• 12 to 35 years old;
• Willing to comply with intensive diabetes management (taking daily multiple insulin injections and monitoring blood sugar closely to maintain good blood sugar control).

Study subjects enrolled will be those who meet the eligibility criteria and provide written informed consent.

Procedures

If you qualify and consent to the study, participants will be randomly assigned (like the flip of a coin) into either a group that gets the active or a placebo treatment.

Contact

If you are interested in participating in the this study, please review the consent form. Once you have reviewed the forms, please contact Kari Benassi at (650) 736-8948 or by email at karis@stanford.edu to discuss your eligibility and any questions you may have.

Please review the consent forms for more information.

• Consent
• Assent