Type 2 Diabetes Mellitus (T2DM)Phase 2NCT06789302
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
A Phase 2 study testing DT2-SCT intravenous infusion in people with Type 2 Diabetes Mellitus (T2DM), run by Global Institute of Stem Cell Therapy and Research.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- DT2-SCT intravenous infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
- Subject who is pregnant or nursing
- Subject is on chronic immunosuppressive transplant therapy
- Subjects who tested positive for HIV 1/2, HBV, HCV, HTLV I/II, WNV, and syphilis
- Flu symptoms
- Any past history of lipid disorders: lipedema, lipomatosis, or lipodystrophies
- Active cancer, chemotherapy, or other malignancies in the last 6 months prior to the screening
- Any past history of DVT or pulmonary embolism requiring anticoagulants or other medicines
- Requiring supplemental oxygen
- Major surgeries within 6 months prior to the screening
- Wounds/sepsis ongoing or within 3 months prior to the screening
- Any illness which in the Investigator's judgment, may interfere with the subject's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- DT2-SCT intravenous infusion, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DT2-SCT intravenous infusionDrug
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: DT2-SCT Infusion | Experimental | Group A will be given DT2-SCT suspended on Plasma-Lyte A. Receives: Drug: DT2-SCT intravenous infusion |
| Group B: Placebo Treatment | Placebo comparator | Group B will be given Plasma-Lite A only. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (TEAEs) Occurring in Less Than 5% of Participants
Measured: 30 months
Change from Baseline in Insulin Requirements at 6 Months Post-Treatment
Measured: 30 months
Secondary outcomes (2)
Change from Baseline in Glucagon-Stimulated C-Peptide Levels at 6 Months Post-Treatment
Measured: 30 months
Change from Baseline in HbA1c Levels
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study startDec 2025 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Global Institute of Stem Cell Therapy and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789302
- Sponsor's protocol ID
- GIOSTAR-001-2024
- Status last verified
- Aug 2025
- First submitted
- 17 Jan 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06789302
- Acronym / sponsor ID
- GIOSTAR-001-2024
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Global Institute of Stem Cell Therapy and ResearchIndustry (pharma, biotech, devices)
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: DT2-SCT Infusion | Experimental | Drug: DT2-SCT intravenous infusionGroup A will be given DT2-SCT suspended on Plasma-Lyte A. |
| Group B: Placebo Treatment | Placebo comparator | Other: PlaceboGroup B will be given Plasma-Lite A only. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DT2-SCT intravenous infusionDT2-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. | Drug | Group A: DT2-SCT Infusion |
| PlaceboParticipants 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. | Other | Group B: Placebo Treatment |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs) Occurring in Less Than 5% of Participants
Time frame: 30 months
Change from Baseline in Insulin Requirements at 6 Months Post-Treatment
Time frame: 30 months
2 secondary outcomes
Change from Baseline in Glucagon-Stimulated C-Peptide Levels at 6 Months Post-Treatment
Time frame: 30 months
Change from Baseline in HbA1c Levels
Time frame: 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
Related trials for Type 2 Diabetes Mellitus (T2DM)
Recruiting
Lifestyle Medicine for Type 2 Diabetes Remission in Pakistan
Type-2 Diabetes Mellitus (T2DM), Diabetes Remission
Not yet recruitingObservational study
Endocrine Disruption, Menopause, and Poor Sleep in wOmen With Type 2 Diabetes: Effects on Cardiovascular Health
Menopause, Sleep Disruption
Active, not recruiting
Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
Nutrition, Type 2 Diabetes
Not yet recruiting
Physiologic Insulin Resensitization (PIR) Treatment in Patients With a Diagnosis of Type 2 Diabetes Mellitus (T2DM)
Type 2 Diabetes Mellitus
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DT2-SCT intravenous infusion in people with Type 2 Diabetes Mellitus (T2DM), run by Global Institute of Stem Cell Therapy and Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mukesh Kumar, PhD, RAC (240-750-4893, mkumar@fdamap.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (TEAEs) Occurring in Less Than 5% of Participants (time frame: 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.