Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT07495956

cfMSC Therapy for Diabetes

Led by Shenzhen Geno-Immune Medical Institute · Updated on 2026-03-27

30

Participants Needed

1

Research Sites

215 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

cfMSC Therapy for Diabetes

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand the study and sign informed consent
  • Diagnosed with type II diabetes mellitus for more than 3 years with poor blood sugar control (HbA1c 67.5% for 3 consecutive months)
  • Age between 18 and 75 years
  • Body mass index (BMI) between 18.5 and 35 kg/m8
  • Fasting C-peptide level between 0.3 and 1.5 ng/mL indicating residual islet function
  • Karnofsky performance score of 70 or higher with good daily living ability
  • Life expectancy longer than 5 years
  • Normal liver and kidney function and normal blood counts
  • No serious diseases of heart, brain, lung, or other important organs; stable vital signs
  • Women of childbearing age must have a negative pregnancy test within 7 days before enrollment and agree to effective contraception during and 1 year after the study
  • Willingness to cooperate throughout the study and complete all examinations and follow-up
Not Eligible

You will not qualify if you...

  • Type 1 diabetes mellitus or other special types of diabetes
  • Severe diabetes complications like end-stage kidney disease, severe eye disease, diabetic foot ulcers or infections
  • History of cancer within 5 years or suspicious malignant tumors
  • Positive for HIV, hepatitis B, hepatitis C or other infectious diseases
  • Active autoimmune diseases or long-term use of glucocorticoids or immunosuppressants (except small dose hormone replacement)
  • History of severe allergic reactions or allergy to study cell components
  • Pregnant or breastfeeding women
  • Participation in other clinical studies currently
  • Mental illness or poor compliance preventing cooperation
  • Any other condition deemed unsuitable by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, China, 518000

Actively Recruiting

Loading map...

Research Team

L

Lung-Ji Chang, ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here