cfMSC Therapy for Diabetes
ConditionType II Diabetes Mellitus
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenzhen Geno-Immune Medical Institute
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- cfMSC therapy for diabetes
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov