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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

December 31, 2025

Primary Completion Date

June 30, 2028

Study Completion Date

June 30, 2028

Conditions
Type 2 Diabetes Mellitus (T2DM)
Interventions
DRUG

DT2-SCT intravenous infusion

"DT2-SCT is an investigational therapy using autologous adipose-derived mesenchymal stem cells (MSCs) prepared from each participant's adipose tissue. MSCs are isolated from approximately 50 mL of adipose tissue obtained through a tumescent liposuction procedure. The cells are expanded, tested for contaminants, and suspended in a sterile, cryopreservation-free medium (Plasma-Lyte A) for administration.~The intervention involves a single intravenous infusion of DT2-SCT at a dosage of 1 x 10\^6 MSCs/kg body weight, delivered over a period of one hour. Participants will be closely monitored for at least two hours post-infusion to assess immediate safety and potential adverse effects."

OTHER

Placebo

Participants in the placebo group (Group B) will receive a single intravenous infusion of Plasma-Lyte A, a sterile, isotonic, non-pyrogenic crystalloid solution. The infusion will be administered in a volume of 100 mL over a period of one hour.

All Listed Sponsors
lead

Global Institute of Stem Cell Therapy and Research

INDUSTRY