Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China, 518000
Actively Recruiting
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
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