A Randomized Controlled Trial on the Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cell … (NCT07183761) | Clinical Trial Compass
RecruitingPhase 2
A Randomized Controlled Trial on the Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cell Therapy in Subjects With Moderate to Severe Diabetic Peripheral Neuropathy
China140 participantsStarted 2025-10-01
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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:
✓. Confirmed neurophysiological dysfunction:
✓. 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.
Exclusion criteria
✕. Non-diabetic neuropathy or pain conditions in lower limbs that may confound DPN assessment per investigator's judgment;
✕. Poorly controlled diabetes (HbA1c \>12%);
✕
What they're measuring
1
Toronto Clinical Scoring System (TCSS) score
Timeframe: From enrollment to week 24 of the study period
2
Incidence of stem cell-related adverse events
Timeframe: From enrollment to week 104 of the study period
3
Incidence of stem cell-associated adverse reactions
Timeframe: From enrollment to week 104 of the study period
. Severe hematological, hepatic, or renal dysfunction, meeting any of the following laboratory criteria:
✕. 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);
✕. 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;