NCT07183761

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Min Long · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Peripheral Neuropathy (DPN)

Interventions

Type	Name	Description
BIOLOGICAL	Experimental Group	On day 0, day 7, and day 28 after enrollment, the study subjects will receive intramuscular injections of hUC-MSCs suspension in normal saline into the medial and lateral muscle groups of both lower legs. Concurrently, all patients will continue to receive conventional therapy.
DRUG	Conventional therapy group	The conventional therapy include fundamental blood glucose management, basic treatment for diabetic neuropathy along with pain management therapy, as well as management of comorbidities and risk factors.

Timeline

• Start date: 2025-10-01
• Primary completion: 2028-04-01
• Completion: 2028-08-30
• First posted: 2025-09-19
• Last updated: 2025-09-19

Locations

1 site across 1 country: China