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
brief 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.
detailed description
This clinical trial is a double-blind, randomized, placebo-controlled Phase IIa study to evaluate the safety and efficacy of DT2-SCT, an autologous adipose-derived mesenchymal stem cell (MSC) therapy, in adults with Type 2 Diabetes Mellitus (T2DM). The study will explore the potential of DT2-SCT to improve glycemic control, reduce insulin resistance, and decrease dependency on insulin and oral glucose-lowering drugs.
Study Design:
The trial involves 120 participants, randomized in a 1:1 ratio to receive either DT2-SCT or a placebo. The investigational product, DT2-SCT, consists of MSCs isolated from each participant's adipose tissue obtained via a tumescent liposuction procedure. The cells are processed, expanded, and prepared in a sterile, cryopreservation-free medium for a single intravenous infusion. The placebo consists of Plasma-Lyte A without MSCs.
Intervention and Monitoring:
Participants will undergo:
Screening and Enrollment: Eligibility will be determined based on inclusion and exclusion criteria, including a comprehensive review of medical history, laboratory tests, and diabetes status.
Liposuction Procedure: Approximately 50 mL of adipose tissue will be collected from the lower abdominal region under local anesthesia. The extracted tissue will be processed to isolate and expand MSCs.
Infusion Phase: Participants will receive either DT2-SCT (1 x 10\^6 cells/kg) or placebo in a 100 mL Plasma-Lyte solution via intravenous infusion over one hour. Safety will be monitored during and after the infusion.
Follow-Up Visits: Participants will be followed for six months, with evaluations at 7 days, 1 month, 3 months, and 6 months post-infusion. These visits include assessments of glycemic control, insulin resistance, adverse events, and overall health.
Objectives:
Primary Objective: To determine the safety and tolerability of a single intravenous dose of DT2-SCT in T2DM patients.
Secondary Objectives:
Assess changes in insulin resistance using the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR).