Type II Diabetes Mellitus
Conditions
Keywords
Clonal fetal MSCs (cfMSCs), Islet function reconstruction, Insulin resistance, Type II diabetes mellitus
Brief summary
The purpose of this study is to assess the feasibility, safety and clinical efficacy of the novel clonal fetal mesenchymal stem cell (cfMSC) therapy in patients with type II diabetes mellitus.
Detailed description
Important Regulatory Notice: This trial record is only for global academic information registration on ClinicalTrials.gov. Neither the sponsor Beijing Meikang Jimian Biotechnology Co., Ltd. nor collaborator Shenzhen Geno-Immune Medical Institute has obtained NMPA clinical trial approval or clinical technology filing permission to carry out interventional cell therapy trials in mainland China. ClinicalTrials.gov registration alone does not represent legal approval by Chinese health and drug regulatory authorities. Type II diabetes mellitus is a chronic metabolic disease with progressive islet β-cell dysfunction and insulin resistance as the core pathogenesis, leading to persistent hyperglycemia and a series of microvascular and macrovascular complications. Conventional treatments including lifestyle intervention, oral hypoglycemic agents and insulin injection can only control blood glucose levels, but cannot reverse the loss and dysfunction of islet β-cells, the root cause of the disease. At present, the clinical treatment of diabetes is mainly based on lifestyle intervention, oral hypoglycemic drugs and insulin injection, which can only control blood glucose and cannot fundamentally repair the damaged islet function and reverse the disease process. Mesenchymal stem cells have the characteristics of multi-directional differentiation potential, immune modulation, anti-inflammatory, allogeneic tolerance and paracrine effects. MSCs could have diverse sources. The fetal tissue-derived clonal MSCs (cfMSCs) have extended expansion potential, high purity and can generate rich levels of various growth factors, and can achieve high quality consistency. The cfMSCs may modulate islet-like cells' differentiation, repair the damaged islet tissue, improve insulin resistance, and regulate the abnormal immune response of the body, which is a potential new strategy for the treatment of diabetes. This study aims to adopt intravenous infusion of cfMSCs to treat patients with type II diabetes who have poor curative effect from the conventional treatment. The goal is to evaluate the safety, feasibility and preliminary clinical efficacy of this novel therapy, and provide important clinical evidence for the clinical transformation and application of cfMSC therapy for diabetes, so as to bring new treatment options for diabetic patients.
Interventions
BIOLOGICALcfMSC therapy for diabetes
Clonal fetal mesenchymal stem cells (cfMSCs) therapy for type II diabetes mellitus
Sponsors
Shenzhen Geno-Immune Medical Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Ability to understand the study protocol and voluntarily sign the written informed consent form; 2. A clear diagnosis of type II diabetes mellitus for more than 3 years, with poor blood glucose control under conventional treatment (HbA1c ≥ 7.5% for 3 consecutive months); 3. Age 18-75 years old, with a body mass index (BMI) of 18.5-35 kg/m²; 4. Fasting C-peptide level 0.3-1.5 ng/mL, indicating residual islet function; 5. Karnofsky performance score (KPS) ≥ 70, with good daily living ability; 6. Life expectancy \> 5 years; 7. Normal liver and kidney functions (bilirubin \< 1.5×ULN, ALT/AST \< 2.5×ULN, creatinine \< 1.5×ULN); normal blood routine (absolute neutrophil count ≥ 1.8×10\^9/L, platelets ≥ 100×10\^9/L); 8. No serious heart, brain, lung and other important organ diseases, and stable vital signs; 9. Women of childbearing age have a negative pregnancy test within 7 days before enrollment, and all subjects of childbearing age agree to take effective contraceptive measures during the study and within 1 year after the end of the study; Willing to cooperate with the whole course of follow-up and complete all examination and observation indicators.
Exclusion criteria
1. Type 1 diabetes mellitus or other special types of diabetes; 2. Severe diabetes-related complications, such as end-stage renal disease, severe proliferative retinopathy, diabetic foot with ulcer and infection, etc.; 3. A history of malignant tumors within 5 years, or current suspicious malignant tumor lesions; 4. HIV, hepatitis B, hepatitis C and other infectious diseases with positive pathogen indicators; 5. Active autoimmune diseases, or long-term use of glucocorticoids and immunosuppressants (except for small dose hormone replacement therapy); 6. A history of severe allergic reactions, or allergy to the components of the study cell preparation; 7. Pregnant or lactating women; 8. Actively participating in other clinical research projects at the same time; 9. Mental diseases or poor compliance that cannot cooperate with the study; Other conditions that the investigator deems unsuitable for participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with adverse events. | 24 weeks | Determine the safety and tolerability of clonal fetal mesenchymal stem cell (cfMSC) therapy with Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of diabetes-related complications. | 36 months | Follow up and record the occurrence and progression of microvascular and macrovascular complications such as diabetic nephropathy, retinopathy and cardiovascular and cerebrovascular diseases. |
| Change of glycated hemoglobin (HbA1c) level. | 24 months | Evaluate the improvement of long-term blood glucose control in patients, with the primary observation of the change range of HbA1c from baseline to 12 and 24 months after treatment. |
| Change of daily C-peptide level. | 24 months | Detect the fasting and postprandial C-peptide levels to evaluate the recovery of endogenous insulin secretion function. |
| Change of daily exogenous insulin dosage. | 24 months | Record the change of daily insulin dosage to evaluate the degree of insulin dependence reduction. |
| Proportion of patients achieving insulin independence. | 36 months | Statistically analyze the number and proportion of patients who achieve complete or partial insulin independence after treatment and maintain the state for more than 6 months. |
Countries
China
Contacts
CONTACTLung-Ji Chang, ph.D
Outcome results
None listed