Stem cells from umbilical cord for moderate to severe diabetic nerve damage

Who can take part

• Males or females aged 18-80 years
• Meeting the 2023 ADA diagnostic criteria for type 2 diabetes
• Presence of symptoms and signs of diabetic neuropathy in lower extremities:; For symptomatic patients: At least one abnormal finding among ankle reflex, pinprick sensation, vibration sense, pressure perception, or temperature sensation, accompanied by clinical symptoms (e.g., symmetric lower limb numbness, pain, or tingling); For asymptomatic patients: At least two abnormal findings in the above five examinations
• Confirmed neurophysiological dysfunction:; Reduced nerve conduction velocity (≥2 standard deviations) in at least one lower extremity nerve (common peroneal, posterior tibial, or deep peroneal nerve), with or without decreased amplitude; Moderate to severe neuropathy severity:
• Toronto Clinical Scoring System (TCSS) score ≥9
• Inadequate response to conventional therapy: Persistent symptoms (reduction of TCSS score <2 points from baseline) despite ≥3 months of conventinal treatment
• Capacity to understand and voluntarily complete all study procedures and interventions, with signed informed consent

Who cannot take part

• Current use of prohibited medications within 5 half-lives prior to enrollment (may be reconsidered after ≥5 half-lives washout)
• Participation in any interventional clinical trial within 3 months prior to screening
• Non-diabetic neuropathy or pain conditions in lower limbs that may confound DPN assessment per investigator's judgment
• Known allergy to stem cells, stem cell-derived products, or components of stem cell preparations
• Uncontrolled systemic diseases, including but not limited to: Severe uncontrolled systemic infections (bacterial, fungal, or viral); Severe autoimmune disorders; Hematological diseases; Heart failure (NYHA class ≥III)
• Clinically significant arrhythmia on 12-lead ECG
• Conditions requiring amputation (e.g., severe diabetic foot or lower limb ulcers) that preclude local stem cell injection
• Other diseases unsuitable for trial participation (e.g., active malignancy, cognitive impairment, depression, or psychiatric disorders)
• Any other condition deemed by the investigator to compromise trial suitability
• Poorly controlled diabetes (HbA1c >12%)
• Severe hematological, hepatic, or renal dysfunction, meeting any of the following laboratory criteria:; Hematology: Neutrophils <1.5×10⁹/L, platelets <90×10⁹/L, or hemoglobin <80 g/L; Liver function: ALT or AST >3× upper limit of normal (ULN), or total bilirubin >1.5× ULN; Renal function: eGFR <30 mL/min/1.73m² (calculated by MDRD formula) or requiring renal replacement therapy; Creatine kinase >2× ULN
• Pregnancy, lactation, or planning pregnancy within 2 years