NCT07495956

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
48mo left

Started Mar 2026

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Mar 2026Apr 2030

Study Start

First participant enrolled

March 16, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2029

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2030

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

March 22, 2026

Last Update Submit

March 22, 2026

Conditions

Type II Diabetes Mellitus

Keywords

Clonal fetal MSCs (cfMSCs)Islet function reconstructionInsulin resistanceType II diabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change of glycated hemoglobin (HbA1c) level.

    24 months

  • Change of daily C-peptide level.

    24 months

  • Change of daily exogenous insulin dosage.

    24 months

  • Proportion of patients achieving insulin independence.

    36 months

  • Incidence of diabetes-related complications.

    36 months

Study Arms (1)

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

EXPERIMENTAL
Biological: cfMSC therapy for diabetes

Interventions

cfMSC therapy for diabetesBIOLOGICAL

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

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to understand the study protocol and voluntarily sign the written informed consent form;
  • 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);
  • Age 18-75 years old, with a body mass index (BMI) of 18.5-35 kg/m²;
  • Fasting C-peptide level 0.3-1.5 ng/mL, indicating residual islet function;
  • Karnofsky performance score (KPS) ≥ 70, with good daily living ability;
  • Life expectancy \> 5 years;
  • 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);
  • No serious heart, brain, lung and other important organ diseases, and stable vital signs;
  • 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.

You may not qualify if:

  • Type 1 diabetes mellitus or other special types of diabetes;
  • Severe diabetes-related complications, such as end-stage renal disease, severe proliferative retinopathy, diabetic foot with ulcer and infection, etc.;
  • A history of malignant tumors within 5 years, or current suspicious malignant tumor lesions;
  • HIV, hepatitis B, hepatitis C and other infectious diseases with positive pathogen indicators;
  • Active autoimmune diseases, or long-term use of glucocorticoids and immunosuppressants (except for small dose hormone replacement therapy);
  • A history of severe allergic reactions, or allergy to the components of the study cell preparation;
  • Pregnant or lactating women;
  • Actively participating in other clinical research projects at the same time;
  • Mental diseases or poor compliance that cannot cooperate with the study; Other conditions that the investigator deems unsuitable for participating in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Central Study Contacts

Lung-Ji Chang, ph.D

CONTACT

+86 0755-86573763c@szgimi.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2026

First Posted

March 27, 2026

Study Start

March 16, 2026

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

April 30, 2030

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)