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A single-center, randomized, placebo-controlled, double-blind, parallel-group comparative trial to evaluate the safety and efficacy of concomitant administration of autologous adipose tissue-derived mesenchymal stem cells (adipose-derived stem cells; ASCs) in patients with type 2 diabetes mellitus whose glycemic control is insufficient with oral hypoglycemic agents.

To evaluate the safety and efficacy of concomitant administration of autologous adipose tissue-derived mesenchymal stem cells (adipose-derived stem cells; ASCs) in patients with type 2 diabetes mellitus whose glycemic control is inadequate.

Nagashima Hirotaka

Nagashima Hirotaka

Tokyo Center Clinic

L.Biz Nihonbashi 3F, 2-9-10 Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan

nagashima_hirotaka@tc-clinic.jp

Takahashi Hozumi

Tokyo Center Clinic

L.Biz Nihonbashi 3F, 2-9-10 Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan

+81-3-3276-6935

takahashi-hozumi@tc-clinic.jp

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1. Patients with type 2 diabetes mellitus aged >=20 and <75 years at the time of informed consent.
2. Male or female patients receiving diet and exercise therapy who are being treated with one or more oral hypoglycemic agents.
3. Patients with HbA1c >=7.0% and <=10.0% (NGSP) at screening.
4. Patients whose type, dosage, and regimen of oral hypoglycemic agents have not been changed for at least 12 weeks prior to obtaining informed consent.
5. Patients who have received sufficient explanation about participation in this study, have understood the information, and have provided written informed consent of their own free will.

1. Patients with type 1 diabetes mellitus.
2. Patients not treated with oral hypoglycemic agents or patients currently treated with insulin.
3. Patients with proliferative diabetic retinopathy.
4. Patients with renal failure or renal impairment defined as an estimated glomerular filtration rate (eGFR) <30 mL/min at screening (severe renal dysfunction, MDRD equation).
5. Patients showing signs of hepatic dysfunction, defined as serum ALT (GPT), AST (GOT), or ALP (alkaline phosphatase) exceeding 3 times the upper limit of normal during the screening period.
6. Patients diagnosed with hypertension and patients with NYHA Class IV or higher heart failure at the time of informed consent.
7. Patients within <6 months after the onset of unstable angina, myocardial infarction, cerebral infarction, cerebral hemorrhage, or transient ischemic attack.
8. Patients with blood disorders associated with hemolysis or unstable red blood cells and other related disorders (e.g., malaria, babesiosis, hemolytic anemia).
9. Patients with a known allergy to penicillin or streptomycin.
10. Patients with a history of hypersensitivity to bovine-derived components.
11. Patients with a current malignancy or a history of malignancy within <5 years prior to enrollment.
12. Patients with thrombosis (e.g., deep vein thrombosis or pulmonary embolism) at the time of informed consent.
13. Patients with myeloproliferative disorders (e.g., leukocytosis, thrombocytosis) or coagulation abnormalities at the time of informed consent.
14. Patients with severe systemic infection (CRP >5 mg/dL).
15. Patients with a history of drug or alcohol abuse within the past 24 months.
16. Patients who test positive for infectious disease screening during the screening period (HCV antibody, HBs antigen, HIV antibody, HTLV-1, syphilis).
17. Patients with resting blood oxygen saturation <93% measured by pulse oximeter.
18. Patients receiving systemic steroid therapy at the time of informed consent, patients whose thyroid hormone dose was changed within 6 weeks prior to informed consent, or patients with uncontrolled endocrine disorders other than type 2 diabetes mellitus.
19. Pregnant or breastfeeding women, women who may become pregnant, or men or women who are unwilling to use contraception during the study participation period.
20. Patients who participated in another clinical trial within 4 weeks prior to informed consent.
21. Patients who are considered inappropriate for participation in this study at the discretion of the principal investigator.

Both

type 2 diabetes

Harvesting of subcutaneous fat and blood samples, followed by administration of a specified cells

type 2 diabetes, messenchymal stem cell

Incidence of adverse events

1. Hypoglycemic events
2. Cardiovascular events
3. Change in Vital signs (blood pressure and pulse rate) at each assessment time point from baseline
4. Change in HbA1c from baseline at each assessment time point
5. Change in fasting blood glucose from baseline at each assessment time point
6. Change in C-peptide from baseline at each assessment time point
7. Change in HOMA-R from baseline at each assessment time point
8. Change in HOMA-beta from baseline at each assessment time point
9. Change in inflammatory biomarkers (e.g., TNF-alpha, IL-6, CRP) from baseline at each assessment time point
10. Change in body weight from baseline at each assessment time point
11. Change in blood urea nitrogen/creatinine from baseline at each assessment time point
12. Change in urinary microalbumin from baseline at each assessment time point
13. Change in diabetic retinopathy from baseline at each assessment time point
14. Presence or absence of dose reduction of antidiabetic medications from baseline at each assessment time point
Dose reduction of antidiabetic medications will be implemented as needed based on HbA1c levels.

Recruiting

+81-3-5802-1584

Aug. 30, 2026

No

none