cfMSC Therapy for Diabetes

Clonal Fetal Mesenchymal Stem Cell (cfMSC) Therapy for Type II Diabetes Mellitus

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.

Study Overview

• Status: Recruiting
• Conditions: Type II Diabetes Mellitus
• Intervention / Treatment: Biological: cfMSC therapy for diabetes

Detailed Description

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
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Lung-Ji Chang, Ph.D; Phone Number: +86 0755-86573763; Email: c@szgimi.org

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518000
      • Recruiting
      • Shenzhen Geno-immune Medical Institute
      • Contact: Lung-Ji Chang, Ph.D; Phone Number: +86 0755-86573763; Email: c@szgimi.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clonal fetal mesenchymal stem cells (cfMSCs) therapy for type II diabetes mellitus	Biological: cfMSC therapy for diabetes; Clonal fetal mesenchymal stem cells (cfMSCs) therapy for type II diabetes mellitus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	24 months
Change of daily exogenous insulin dosage.	Record the change of daily insulin dosage to evaluate the degree of insulin dependence reduction.	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.	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.	36 months

Collaborators and Investigators

• Sponsor: Shenzhen Geno-Immune Medical Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): April 30, 2030

Study Registration Dates

• First Submitted: March 22, 2026
• First Submitted That Met QC Criteria: March 22, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Insulin resistance; Type II diabetes mellitus; Clonal fetal MSCs (cfMSCs); Islet function reconstruction
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Hyperinsulinism; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Insulin Resistance
• Other Study ID Numbers: GIMI-IRB-26002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No