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;
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;
Non-diabetic neuropathy or pain conditions in lower limbs that may confound DPN assessment per investigator's judgment;
Poorly controlled diabetes (HbA1c >12%);
Known allergy to stem cells, stem cell-derived products, or components of stem cell preparations;
Current use of prohibited medications within 5 half-lives prior to enrollment (may be reconsidered after ≥5 half-lives washout);
Min Long
Lead sponsor
Southwest Hospital, China
Sponsor institution