[Patient Recruitment] Clinical Recruitment for Stem Cell Treatment of Type 2 Diabetes

Phase I clinical study on the safety, tolerability, and preliminary efficacy of E10I stem cell therapy for type 2 diabetes

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[Patient Recruitment] Clinical Recruitment for Stem Cell Treatment of Type 2 Diabetes

Target audience:
Patients with refractory type 2 diabetes who still have poor blood glucose control after standard treatment based on diet and exercise

Indications:
type 2 diabetes

Basic inclusion criteria:
1. Aged 18-80 years old.

2. According to the WHO diagnostic criteria for diabetes in 1999, the patient is diagnosed with type 2 diabetes and has had the disease for ≥10 years

3. Female subjects must weigh ≥45kg, while male subjects must weigh ≥50kg, and have a BMI ranging from 18.5 kg/m² to 28.0 kg/m²

4. During screening, diet and exercise control were implemented according to the requirements of the Chinese Diabetes Prevention and Treatment Guidelines (2024 edition). At least three oral hypoglycemic agents or insulin combined with at least two oral hypoglycemic agents (with oral drug doses at standard or maximum tolerated doses, and treatment duration of at least three months) were used. However, blood glucose control was poor (HbA1c ≥ 7.5%).

5. During screening, the fasting C-peptide level should be less than 1.2 nmol/L

6. Female patients of childbearing age who have a negative pregnancy test and are willing to use reliable birth control methods (excluding contraceptives) during the study period and for 6 months after its conclusion. Males who have not undergone sterilization surgery must agree to adopt effective contraceptive measures during the study period and for 6 months after its conclusion.

7. Fully understand the purpose and requirements of this trial, and are willing to adhere to dietary and exercise control in accordance with the requirements of the Chinese Diabetes Prevention and Treatment Guidelines (2024 edition) during the study period. Volunteer to participate and sign a written informed consent form, and be able to complete the trial as required.

Exclusion criteria:
1. Aged 18-80 years old.

1. Diagnosed with type 1 diabetes, or a specific type of diabetes

2. Acute or chronic pancreatitis.

3. Individuals with severe allergies or hypersensitivity to any components in the medication (such as human albumin, dextran, dimethyl sulfoxide, etc.);

4. Patients who have received other stem cell treatments before screening.

5. Participated in other therapeutic clinical trials within 4 weeks before drug administration.

6. During screening, there is a history of acute diabetic complications such as diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar state (HHS), or lactic acidosis, or severe diabetic complications such as retinal lesions entering the proliferative stage, painful neuropathy, or vascular lesions with obstruction exceeding 50%;

7. Screen for those who have experienced severe hypoglycemic events or recurrent hypoglycemic events within the previous 6 months (≥3 hypoglycemic events within a week [excluding possible symptomatic hypoglycemia], or at least 3 blood glucose levels <3.0 mmol/L [<54 mg/dL] detected within a week, or other hypoglycemic events as determined by the investigator).

8. Patients with severe systemic diseases (such as central nervous system, cardiovascular system, hematological system, digestive system, endocrine system, respiratory system, urogenital system, immune system, psychiatric disorders, etc.);

9. Any malignant tumor that has not been deemed cured (excluding basal cell carcinoma, squamous cell carcinoma, and papillary thyroid microcarcinoma); .

10. Suffering from other uncontrolled or untreated endocrine, metabolic, or chronic diseases.

11. During screening, the coagulation function test indicators should meet the following criteria: INR ≥ 1.3 (without the use of anticoagulants).

12. During screening, the following laboratory test results are required: fasting glucose >15.0 mmol/L; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5×upper limit of normal (ULN); total bilirubin >1.5×ULN; amylase/lipase >1.5×ULN; estimated creatinine clearance rate <60 mL/min (estimated using the Cockroft-Gault formula);

13. Suffering from cardiovascular and cerebrovascular diseases, defined as: experiencing congestive heart failure (NYHA III-IV), unstable angina, stroke, myocardial infarction, or undergoing coronary revascularization within the previous 6 months; and/or planning to undergo coronary, carotid, or peripheral artery revascularization at the time of screening.

14. During screening, there were cases of uncontrolled severe hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg) or hypotension (systolic blood pressure <90 mmHg).

15. During screening, the following conditions of electrocardiogram (ECG) results are considered: ① The results show clinically significant abnormalities, such as supraventricular tachycardia, atrial fibrillation, atrial flutter, second- or third-degree atrioventricular block, etc., and the researchers consider the subjects unsuitable for inclusion in this study. ② The results indicate that the ECG QTcF (QT interval corrected by Fridericia formula (QTcF)) is greater than 450 ms (for females, it is greater than 480 ms).

16. Screen for individuals who have experienced the following conditions within the previous 6 months: thrombotic or embolic venous or arterial events, such as cerebrovascular accidents, including transient ischemic attack, stroke, arterial thrombosis, deep vein thrombosis, and pulmonary embolism.

17. Any acute or chronic infectious diseases that pose risks to patients;

18. During screening, if the patient has severe uncontrolled pulmonary diseases, including pulmonary fibrosis, interstitial lung disease, acute exacerbation of chronic obstructive pulmonary disease, active pulmonary infection, etc.

19. Those who have donated whole blood or experienced blood loss ≥400 mL within 12 weeks prior to the first dose;

20. During screening, individuals who are positive for hepatitis B virus surface antigen [HBsAg] (except for those whose quantitative detection results of hepatitis B virus [HBV] deoxyribonucleic acid [DNA] are below the lower limit of the detection reference range), or positive for hepatitis C virus [HCV] antibody, or positive for human immunodeficiency virus [HIV] antibody, or positive for syphilis antibody

21. Patients who have taken immunosuppressive drugs (such as azathioprine and methotrexate) within the first 24 weeks before the study;

22. Screen for individuals with a history of drug abuse within the previous 24 weeks;

23. Individuals with a strong smoking or drinking habit (smoking more than 10 cigarettes per day; consuming 14 units of alcohol per week: 1 unit = 360mL of beer, or 45mL of strong liquor with an alcohol content of 40%, or 150mL of wine);

24. Patients who, in the opinion of the investigator, are not suitable for participation in this clinical trial due to various reasons.

E10I Clinical approval:
E10I