Not yet taking people in ChinaPhase 1/2
Fetal Stem Cell Therapy for Type 2 Diabetes
Tests stem cells from fetal tissue in adults with type 2 diabetes.
Key facts
- Who runs it
- Shenzhen Geno-Immune Medical Institute
- Where
- Shenzhen, ChinaSee the site
- Trial code
- Registry title
- cfMSC Therapy for Diabetes
- Status
- Not yet recruiting
- Phase
- Phase 1/2
- People taking part
- 30 people, planned
- Starts
- 30 Jun 2027
- Expected to end
- 31 Dec 2029
- Type of study
- Interventional
- Treatments tested
- cfMSC therapy for diabetes
- Record updated
- 2 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18-75 with type 2 diabetes for more than 3 years whose blood sugar is still poorly controlled on usual treatment. It tests a stem cell therapy.
- Age
- 18-75 years
- Sex
- All sexes can join.
- Disease stage
- Type 2 diabetes diagnosed for more than 3 years, with HbA1c ≥ 7.5% (58 mmol/mol) for 3 months in a row, fasting C-peptide 0.3-1.5 ng/mL (some islet function left), and BMI 18.5-35 kg/m².
- Earlier treatment
- Blood sugar must be poorly controlled under conventional treatment.
- Biomarker or test result
- HbA1c ≥ 7.5% (58 mmol/mol) for 3 consecutive months; fasting C-peptide level 0.3-1.5 ng/mL.
Main reasons for not taking part
- Type 1 diabetes or other special types of diabetes
- Severe diabetes complications such as end-stage kidney disease or severe eye disease
- Cancer within the last 5 years, or a suspicious tumour now
- Positive for HIV, hepatitis B, hepatitis C or other infections
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Mental diseases or poor compliance that cannot cooperate with the study; Other conditions that the investigator deems unsuitable for participating in the study
- Pregnant or lactating women
- Actively participating in other clinical research projects at the same time
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in China
- Shenzhen Geno-immune Medical InstituteShenzhen, ChinaContact: Lung-Ji Chang, ph.DNo longer taking part
About the trial
What the trial wants to find out
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.
The group in the trial
- Clonal fetal mesenchymal stem cells (cfMSCs) therapy for type II diabetes mellitusTreatment being tested
Treatment: cfMSC therapy for diabetes
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Clonal Fetal Mesenchymal Stem Cell (cfMSC) Therapy for Type II Diabetes Mellitus
- Plain-language title
- Fetal Stem Cell Therapy for Type 2 DiabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07495956, who can take part
- Record updated
- 2 November 2026