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

Launched by GLOBAL INSTITUTE OF STEM CELL THERAPY AND RESEARCH · Jan 17, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called DT2-SCT for adults with Type 2 Diabetes Mellitus (T2DM). The goal is to see if this therapy can help lower insulin resistance, improve blood sugar levels, and reduce the need for insulin or other diabetes medications. Participants in the study will be randomly assigned to receive either the DT2-SCT treatment or a placebo (a substance with no active medication). After a procedure to collect fat tissue, the stem cells from that tissue will be used in the treatment. Participants will have follow-up visits over six months to check on their health, blood sugar control, and any side effects.

To join the study, individuals must be between 30 and 75 years old, have T2DM, and meet certain health criteria, such as not needing more than a specific amount of insulin. They should also be in generally good health and able to attend all study visits. Importantly, the trial is not yet recruiting participants, so those interested will need to wait until it begins. This study could offer a potential new approach for managing Type 2 diabetes, but it’s essential for participants to understand the requirements and commitment involved.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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
• • 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