Human Cord Blood Mononuclear Cells in the Treatment of Refractory Diabetic Foot
Refractory Diabetic Foot, Human Cord Blood-derived Mononuclear Cells, Efficacy
About this trial
This is an interventional treatment trial for Refractory Diabetic Foot
Eligibility Criteria
Inclusion Criteria: Patients aged 18-80 years; Meet the diagnostic criteria of diabetic foot by International Clinical Guidelines for Diabetic Foot; Ulcer course ≥8 weeks, Wagner grade ≥2; There was no healing trend (no reduction in wound size and no obvious new granulation tissue) after 4 weeks or above treatment. Or the ulcer was further aggravated (by Wagner's grade assessment) in the course of standardized treatment; Fasting blood glucose ≤9mmol/L, 2h postprandial blood glucose ≤13mmol/L; Signing informed consent. Exclusion Criteria: Patients with a history of ketoacidosis and hyperosmosis within 6 months; Patients with viral infection (treponema pallidum, active hepatitis, HIV, Epstein-Barr virus, etc.) Patients with malignant disease or cured of basal cell carcinoma within the past 5 years; Creatinine clearance < 45ml/min; Patients with severe heart failure (NYHA III-IV); Patients with a history of myocardial infarction or cerebral infarction in the last 3 months; Patients who have received cell or growth factor therapy in the past year; Patients during pregnancy or lactation; Patients with abnormal thyroid dysfunction history or abnormal control through drug treatment; Patients with severe hepatic failure (ALT, AST: above 3 times the upper limit of normal); Lower extremity arterial with large artery occlusion by ultrasound image; Patients with a history of severe coagulation disorder or hemorrhagic disease; Patients with sequelae of cerebral infarction or other reasons that cannot extend their lower limbs flat; Patients with psychological or mental disorders who cannot cooperate with treatment; Participate in other clinical research within the past three months; Patients are unable to complete the study or comply with the requirements of the study by investigator's judgment.
Sites / Locations
- the First Affiliated Hospital of Nanjing Medical UniversityRecruiting
Arms of the Study
Arm 1
Experimental
human cord blood-derived mononuclear cells (HCB-MNCs)
About 1×10^8 of HCB-MNCs were injected 3 times at a week interval for each participant.