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

NCT06789302 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: GIOSTAR-001-2024
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events (TEAEs) Occurring in Less Than 5% of Participants

  30 months

• Change from Baseline in Insulin Requirements at 6 Months Post-Treatment

  30 months

Secondary Outcomes (2)

• Change from Baseline in Glucagon-Stimulated C-Peptide Levels at 6 Months Post-Treatment

  30 months

• Change from Baseline in HbA1c Levels

  30 months

Study Arms (2)

Group A: DT2-SCT Infusion

EXPERIMENTAL

Group A will be given DT2-SCT suspended on Plasma-Lyte A.

Drug: DT2-SCT intravenous infusion

Group B: Placebo Treatment

PLACEBO COMPARATOR

Group B will be given Plasma-Lite A only.

Other: Placebo

Interventions

DT2-SCT intravenous infusion DRUG

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.

Group A: DT2-SCT Infusion

Placebo OTHER

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.

Group B: Placebo Treatment

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (male or female) between ages of 30 - 75 years
• Should have Type 2 diabetes mellitus
• With Insulin requirement of 0.7 IU/kg/d or 50 IU/d, whichever is lesser
• Glutamic acid decarboxylase (GAD) antibody status should be negative
• Body Mass Index (BMI) 19 - 30 kg/m2
• Fasting blood glucose (FBG) should be ≥ 7.0 mmol/L, and HbAc1 ≥ 7%
• Intravenous insulin tolerance tests (ITT) indicate a patient's insulin resistance
• Should be ambulatory and in good general health
• Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions
• Willing to abstain from the use of protocol-restricted treatments from Screening through the End-of-Treatment
• No clinically significant abnormalities observed in medical history, physical exam vital signs, and laboratory assessments
• For females with reproductive potential: Should agree to use effective contraception for at least 1 month prior to screening and should agree to use such a method till end of the study period and negative pregnancy test
• For males with reproductive potential: should use condoms and other methods to ensure effective contraception with a partner

You may not qualify if:

• Subjects with Type 1 Diabetes Mellitus (T1DM) or secondary diabetes
• Subjects with serum creatinine 1.5 mg/dl or higher
• Abnormal liver function test (defined as value of transaminases \> 3 times the upper limit of normal or serum bilirubin higher than normal for the reference value for the laboratory)
• History of myocardial infarction or unstable angina in previous 3 months
• History of malignancy or current malignancy other than non-melanomatous skin cancer
• Subjects with active infections
• Subject with serious medical conditions other than cardiovascular disease
• Subject with, or with a medical history of auto-immune diseases
• Subject with a medical history of mental disorder or epilepsy
• Subject abuse alcohol 10 times a week or smoke 25 cigarettes a day
• Subject who was diagnosed with cancer within 5 years before screening
• Subject who participated in another clinical trial within 6 months prior to the screening of this clinical trial
• Subject who was administered with immunosuppressants such as cyclosporin A or azathioprine within 6 weeks prior to the screening
• Serious life-threatening conditions
• Allergies to anesthesia

Sponsors & Collaborators

• Global Institute of Stem Cell Therapy and Research: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Mukesh Kumar, PhD, RAC

CONTACT

240-750-4893; mkumar@fdamap.com

Anand Srivastava, PhD, MS

CONTACT

858-344-2492; anand@giostar.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 22, 2025

Record last verified: 2025-08