Actively Recruiting
Clonal Fetal Mesenchymal Stem Cell Therapy for Type II Diabetes Mellitus
Led by Shenzhen Geno-Immune Medical Institute · Updated on 2026-03-27
30
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the feasibility, safety, and clinical effects of a new therapy using clonal fetal mesenchymal stem cells (cfMSCs) in adults with type II diabetes mellitus. Type II diabetes is a chronic condition characterized by progressive damage to insulin-producing cells and resistance to insulin, leading to high blood sugar and various complications. Current treatments control blood sugar but do not repair damaged insulin-producing cells or reverse the disease. The study involves giving patients an intravenous infusion of cfMSCs, which have potential to repair damaged islet cells, improve insulin resistance, and regulate the immune system. This therapy is being tested in people who have had type II diabetes for more than three years and whose blood sugar is poorly controlled despite standard treatments. The trial will assess safety and initial clinical benefits over several months. Participants will be monitored for side effects and changes in their blood sugar control, insulin usage, and diabetes-related complications over up to 36 months. The main safety measure is the number of patients experiencing adverse events within 24 weeks. Secondary measures include changes in blood sugar markers, insulin dosage, and complication rates. Participants will have regular tests, including blood tests for glycated hemoglobin and C-peptide levels, and their health status will be followed closely throughout the study.
CONDITIONS
Brief Title
cfMSC Therapy for Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand the study and voluntarily sign informed consent
- Diagnosed with type II diabetes mellitus for more than 3 years with poor blood sugar control (HbA1c ≥ 7.5% for 3 months)
- Aged 18 to 75 years with body mass index between 18.5 and 35 kg/m²
- 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 greater than 5 years
- Normal liver and kidney function and normal blood counts
- No serious heart, brain, lung, or other organ diseases and stable vital signs
- Negative pregnancy test for women of childbearing age and agreement to use effective contraception during study and for 1 year after
- Willingness to complete all follow-up and examinations
You will not qualify if you...
- Type 1 diabetes or other special diabetes types
- Severe diabetes complications such as end-stage kidney disease, severe retinopathy, or infected diabetic foot ulcers
- History of cancer within 5 years or current suspicious tumors
- Positive for HIV, hepatitis B or C, or other infectious diseases
- Active autoimmune diseases or long-term use of steroids or immunosuppressants (except small dose hormone replacement)
- History of severe allergic reactions or allergy to study cell products
- Pregnant or breastfeeding women
- Participation in other clinical trials currently
- Mental illness or poor compliance preventing cooperation
- Any other condition the investigator considers unsuitable for participation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive intravenous infusions of clonal fetal mesenchymal stem cells (cfMSCs) as a novel therapy for type II diabetes mellitus.
Multiple visits during the 24-week treatment period for infusions and assessments
Duration - up to 36 months
Participants are monitored for safety and clinical outcomes including blood sugar control, insulin use, and diabetes-related complications.
Periodic visits for up to 36 months after treatment completion
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
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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