cfMSC Therapy for Diabetes

Phase 2Not Yet RecruitingNCT07495956

Shenzhen Geno-Immune Medical Institute30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type II Diabetes Mellitus

Interventions

cfMSC therapy for diabetesBIOLOGICAL

Clonal fetal mesenchymal stem cells (cfMSCs) therapy for type II diabetes mellitus

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, China

Outcomes

Primary Outcomes

Number of patients with adverse events.

Determine the safety and tolerability of clonal fetal mesenchymal stem cell (cfMSC) therapy with Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Time frame: 24 weeks

Secondary Outcomes

Change of glycated hemoglobin (HbA1c) level.

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.

Time frame: 24 months

Change of daily C-peptide level.

Detect the fasting and postprandial C-peptide levels to evaluate the recovery of endogenous insulin secretion function.

Time frame: 24 months

Change of daily exogenous insulin dosage.

Record the change of daily insulin dosage to evaluate the degree of insulin dependence reduction.

Time frame: 24 months

Proportion of patients achieving insulin independence.

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.

Time frame: 36 months

Incidence of diabetes-related complications.

Follow up and record the occurrence and progression of microvascular and macrovascular complications such as diabetic nephropathy, retinopathy and cardiovascular and cerebrovascular diseases.

Time frame: 36 months

Central Contacts

Lung-Ji Chang, ph.D

CONTACT

+86 0755-86573763 c@szgimi.org

Data from ClinicalTrials.gov

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