Refractory Diabetic Peripheral Neuropathy
Conditions
Interventions
Control group :thioctic acid injection 600mg/day, intravenous drip, for 15 consecutive days.
experimental group :Umbilical cord mesenchymal stem cell injection solution, multi-point injection in the lower limb muscles, the injection volume is estimated based on the total area of the lower lim
Sponsors
The Central Hospital of Wuhan
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Ages at 18-70 years (including 18 and 70 years), regardless of gender; 2. Understand and sign the ICF before proceeding with any steps related to this study, comply with the requirements, and do not to participate in other clinical studies during this research; 3. T2DM patients defined by the 2013 American Diabetes Association (ADA) standards; 4. Meet the diagnostic criteria for diabetic peripheral neuropathy: (1) A clear history of diabetes; (2) Neuropathy that occurs on or after the diagnosis of diabetes; (3) Clinical symptoms and signs are consistent with DPN; (4) People with clinical symptoms (pain, numbness, abnormal sensation, etc.), had any 1 of the 5 items of ankle reflex, acupuncture pain, vibration, pressure, and temperature in abnormal; people without clinical symptoms had any 2 of the 5 items were abnormal; 5. The evaluation of symptoms and signs of neuropathy is at a severe level (TCSS score >=12); 6. Conventional drug treatment is ineffective: After using at least three drugs recommended in the "Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus (2020 Edition)" for the treatment of diabetic peripheral neuropathy (for details, see Appendix 1) for at least six months, the symptoms of diabetic peripheral neuropathy have not been significantly relieved (the TCSS score has decreased by less than 30%).
Exclusion criteria
Exclusion criteria: 1. Diseases that the investigator believes that may interfere with subject compliance, including any uncontrolled diseases like in urinary, circulatory, respiratory, nervous, mental, digestive, endocrine, immune, and other system; 2. Pregnant women, breastfeeding women, or those who have a childbearing plan soon; 3. Patients who are known to be allergic to cell products; 4. People with various types of malignancies or hematological diseases; 5. Complicated with severe lower extremity arterial disease (ankle-brachial index < 0.9) 6. Complicated with foot ulcers, infections, or lower extremity amputation; 7. Combined with neuropathy caused by other causes, such as lumbar spondylosis, cerebral infarction, Guillain-Barre Syndrome, excluding severe arteriovenous vascular disease, application of some chemotherapy drugs or renal insufficiency, etc. Nerve damage disease; 8. Those who are unable or unwilling to provide informed consent or fail to comply with research requirements; 9. Participated in other stem cell clinical research before enrollment; 10. Participated in other clinical trials within 3 months before enrollment. 11. Patients with positive serum HIV antibodies; 12. Patients with a history of alcohol and drug abuse failed to abstain effectively.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toronto Clinical Scoring System(TCSS) scale;Examination of nerve conduction velocity in lower extremities; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum inflammatory factors, growth factors;Fasting blood glucose, glycosylated hemoglobin; | — |
Countries
China
Contacts
Public ContactShi Zhao
The Central Hospital of Wuhan
Outcome results
None listed