Using human cord blood cells to treat difficult diabetic foot ulcers
Clinical Study on the Safety and Efficacy of Local Injection of Human Cord Blood Mononuclear Cells in the Treatment of Refractory Diabetic Foot
This study is testing if injections of special cells from human cord blood can help heal stubborn diabetic foot ulcers in people who haven't found relief from standard treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing) |
| Trial ID | NCT05999656 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of local injections of human cord blood-derived mononuclear cells (HCB-MNCs) in patients suffering from refractory diabetic foot ulcers. The study aims to enroll 24 patients aged 18-80 who have not responded to conventional treatments for at least 8 weeks. By utilizing the regenerative properties of HCB-MNCs, the trial seeks to promote wound healing and alleviate symptoms associated with diabetic foot complications. Participants will receive injections directly into their diabetic foot wounds to assess the potential benefits of this innovative cell therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with diabetic foot ulcers that have not shown improvement after 8 weeks of standard treatment.
Not a fit: Patients with severe heart failure, recent history of myocardial infarction, or those with certain infections or malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing outcomes for patients with refractory diabetic foot ulcers, potentially reducing the need for amputations.
How similar studies have performed: Previous studies have shown promising results with similar approaches using HCB-MNCs for treating diabetic foot ulcers, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged 18-80 years; 2. Meet the diagnostic criteria of diabetic foot by International Clinical Guidelines for Diabetic Foot; 3. Ulcer course ≥8 weeks, Wagner grade ≥2; 4. 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; 5. Fasting blood glucose ≤9mmol/L, 2h postprandial blood glucose ≤13mmol/L; 6. Signing informed consent. Exclusion Criteria: 1. Patients with a history of ketoacidosis and hyperosmosis within 6 months; 2. Patients with viral infection (treponema pallidum, active hepatitis, HIV, Epstein-Barr virus, etc.) 3. Patients with malignant disease or cured of basal cell carcinoma within the past 5 years; 4. Creatinine clearance \< 45ml/min; 5. Patients with severe heart failure (NYHA III-IV); 6. Patients with a history of myocardial infarction or cerebral infarction in the last 3 months; 7. Patients who have received cell or growth factor therapy in the past year; 8. Patients during pregnancy or lactation; 9. Patients with abnormal thyroid dysfunction history or abnormal control through drug treatment; 10. Patients with severe hepatic failure (ALT, AST: above 3 times the upper limit of normal); 11. Lower extremity arterial with large artery occlusion by ultrasound image; 12. Patients with a history of severe coagulation disorder or hemorrhagic disease; 13. Patients with sequelae of cerebral infarction or other reasons that cannot extend their lower limbs flat; 14. Patients with psychological or mental disorders who cannot cooperate with treatment; 15. Participate in other clinical research within the past three months; 16. Patients are unable to complete the study or comply with the requirements of the study by investigator's judgment.
Where this trial is running
Nanjing
- the First Affiliated Hospital of Nanjing Medical University — Nanjing, China (Recruiting)
Study contacts
- Study coordinator: Xuqin Zheng
- Email: zhengxuqin@njmu.edu.cn
- Phone: 13912902902
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.