A Double-Blind, Randomized, Placebo-Controlled Phase IIa Clinical Trial to Evaluate the Safety and Efficacy of DT2-SCT in Subjects With Type 2 Diabetes Mellitus

Summary

The goal of this clinical trial is to evaluate the safety and effectiveness of DT2-SCT, a therapy using autologous adipose-derived mesenchymal stem cells, in adults with Type 2 Diabetes Mellitus (T2DM). The study aims to determine if DT2-SCT can reduce insulin resistance, improve blood sugar levels, and decrease the need for insulin or oral glucose-lowering medications. Participants will be randomly assigned to receive either DT2-SCT or a placebo. They will undergo a single intravenous infusion after a liposuction procedure to collect adipose tissue, which will be processed to isolate stem cells for the therapy. The study involves follow-up visits over six months to monitor safety, insulin resistance, blood sugar control, and any potential side effects.

Timeline

Start

2025-12

Primary completion

2028-06

Completion

2028-06

Drugs

Indications