Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT06789302
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-22
First Post:
2025-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Global Institute of Stem Cell Therapy and Research
Organization:
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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).
Evaluate changes in fasting blood glucose (FBG) and HbA1c levels compared to baseline.
Measure the reduction in insulin and oral glucose-lowering drug dosages.
Methodology:
The MSCs used in DT2-SCT are self-renewing, multipotent cells with documented capacity for differentiation into various cell types, including pancreatic β-cells. The mechanism of action includes immunomodulation, anti-inflammatory effects, and potential enhancement of β-cell regeneration. These properties suggest that DT2-SCT could address both insulin resistance and β-cell dysfunction in T2DM.
Statistical Considerations:
The sample size of 120 participants is designed to provide robust safety data and meaningful descriptive results for efficacy. An interim safety analysis will be conducted after the first 20 participants complete their 3-month follow-up.
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).
Evaluate changes in fasting blood glucose (FBG) and HbA1c levels compared to baseline.
Measure the reduction in insulin and oral glucose-lowering drug dosages.
Methodology:
The MSCs used in DT2-SCT are self-renewing, multipotent cells with documented capacity for differentiation into various cell types, including pancreatic β-cells. The mechanism of action includes immunomodulation, anti-inflammatory effects, and potential enhancement of β-cell regeneration. These properties suggest that DT2-SCT could address both insulin resistance and β-cell dysfunction in T2DM.
Statistical Considerations:
The sample size of 120 participants is designed to provide robust safety data and meaningful descriptive results for efficacy. An interim safety analysis will be conducted after the first 20 participants complete their 3-month follow-up.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: