A Randomized Controlled Trial Evaluating the Efficacy and Safety of Intramuscular Human Umbilical Cord Mesenchymal Stem Cell Therapy for Subjects With Moderate to Severe Diabetic Peripheral Neuropathy
This clinical trial aims to evaluate the efficacy and safety of human umbilical cord mesenchymal stem cell (hUC-MSC) injection in the treatment of adults with moderate to severe diabetic peripheral neuropathy. Researchers will compare hUC-MSCs injection combined with conventional therapy (experimental group) to conventional therapy alone (control group) to see if hUC-MSCs work to treat diabetic peripheral neuropathy. The experimental group will receive three injections of hUC-MSCs (on Day 0, Day 7, and Day 28) while continuing conventional therapy, whereas the control group will receive conventional therapy only. Participants will undergo regular follow-ups for checkups and tests over a 24-week period. The primary endpoint of the study is the change in the Toronto Clinical Scoring System (TCSS) score at Week 24. Safety assessments will be conducted throughout the entire study period, with extended follow-up until Week 104 to evaluate long-term safety.
• 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.