Treatment With Human Umbilical Cord Mesenchymal Stem Cells for Refractory Diabetic Peripheral Neuropathy

Inclusion Criteria:

• Ages at 18-55 years (including 18 and 55 years), regardless of gender;
• 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 studiesduring this research;
• T2DM patients defined by the 2013 American Diabetes Association (ADA) standards;
• Meet the diagnostic criteria for diabetic peripheral neuropathy: ① A clear history ofdiabetes; ② Neuropathy that occurs on or after the diagnosis of diabetes; ③Clinicalsymptoms 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 withoutclinical symptoms had any 2 of the 5 items were abnormal;
• The evaluation of symptoms and signs of neuropathy is at severe level (TCSS score ≥12);
• For conventional standard drug treatment (combined use of Lipoic Acid Capsules, Methylcobalamin Tablets, and Epalrestat Tablets) at least 6 months and TCSS score decrease ≤30%;

Exclusion Criteria:

• Diseases that the investigator believes that it may interfere with subject compliance,including any uncontrolled diseases like in urinary, circulatory, respiratory,nervous, mental, digestive, endocrine, immune, and other system;
• Pregnant women, breastfeeding women or those who have a childbearing plan soon;
• Patients who are known to be allergic to cell products;
• People with various types of malignancies or hematological diseases;
• Complicated with severe lower extremity arterial disease (ankle-brachial index < 0.9)
• Complicated with foot ulcers, infections, or lower extremity amputation;
• Combined with neuropathy caused by other causes, such as lumbar spondylosis, cerebralinfarction, Guillain-Barre Syndrome, excluding severe arteriovenous vascular disease,application of some chemotherapy drugs or renal insufficiency, etc. Nerve damagedisease;
• Those who are unable or unwilling to provide informed consent or fail to comply withresearch requirements;
• Participated in other stem cell clinical researches before enrollment;
• Participated in other clinical trials within 3 months before enrollment.
• Patients with positive serum HIV antibodies;
• Patients with a history of alcohol and drug abuse and failed to abstain effectively