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Clinical Trial NCT07495956 for Type II Diabetes Mellitus is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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cfMSC Therapy for Diabetes Phase 1, Phase 2 30 Novel Treatment

Recruiting
Clinical Trial NCT07495956 is designed to study Treatment for Type II Diabetes Mellitus. It is a Phase 1 Phase 2 interventional study that is recruiting, having started on March 16, 2026, with plans to enroll 30 participants. Led by Shenzhen Geno-Immune Medical Institute, it is expected to complete by April 30, 2030. The latest data from ClinicalTrials.gov was last updated on March 27, 2026.
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
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 a...Show More
Official Title

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

Conditions
Type II Diabetes Mellitus
Other Study IDs
  • GIMI-IRB-26002
NCT ID Number
NCT07495956
Start Date (Actual)
2026-03-16
Last Update Posted
2026-03-27
Completion Date (Estimated)
2030-04-30
Enrollment (Estimated)
30
Study Type
Interventional
PHASE
Phase 1
Phase 2
Status
Recruiting
Keywords
Clonal fetal MSCs (cfMSCs)
Islet function reconstruction
Insulin resistance
Type II diabetes mellitus
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalClonal fetal mesenchymal stem cells (cfMSCs) therapy for type II diabetes mellitus
cfMSC therapy for diabetes
Clonal fetal mesenchymal stem cells (cfMSCs) therapy for type II diabetes mellitus
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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.

  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.
Shenzhen Geno-Immune Medical Institute logoShenzhen Geno-Immune Medical Institute
Study Central Contact
Contact: Lung-Ji Chang, ph.D, +86 0755-86573763, [email protected]
1 Study Locations in 1 Countries

Guangdong

Shenzhen Geno-immune Medical Institute, Shenzhen, Guangdong, 518000, China
Lung-Ji Chang, ph.D, Contact, +86 0755-86573763, [email protected]
Recruiting