Umbilical cord mesenchymal stem cell injections for 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

It will try injections of umbilical cord mesenchymal stem cells alongside usual care to see if they reduce nerve symptoms in adults with moderate to severe diabetic peripheral neuropathy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Southwest Hospital, China (Academic / other)
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT07183761 on ClinicalTrials.gov

What this trial studies

This randomized, controlled Phase 2 trial compares three injections of human umbilical cord mesenchymal stem cells plus conventional therapy to conventional therapy alone in adults with moderate to severe diabetic peripheral neuropathy. The experimental group receives hUC-MSC injections on Day 0, Day 7, and Day 28 while both groups continue standard medical care. The primary endpoint is change in the Toronto Clinical Scoring System (TCSS) score at Week 24, with safety monitored throughout and extended follow-up to Week 104 for long-term safety data. Participants must meet neurophysiological criteria for neuropathy and will attend regular visits for clinical and nerve-conduction assessments.

Who should consider this trial

Good fit: Adults 18–80 with type 2 diabetes, TCSS ≥9, confirmed nerve conduction abnormalities in the lower limbs, and inadequate response to conventional therapy are the ideal candidates.

Not a fit: People with mild neuropathy, non-diabetic neuropathies, unstable medical conditions, or those who are already responding to standard treatments are unlikely to receive benefit from this specific intervention.

Why it matters

Potential benefit: If successful, the treatment could reduce neuropathic symptoms and improve nerve function and quality of life for people with moderate to severe diabetic peripheral neuropathy.

How similar studies have performed: Small early-phase and pilot studies of mesenchymal stem cells for diabetic neuropathy have shown promising signals for symptom and nerve-function improvement, but high-quality randomized evidence is still limited.

Eligibility criteria

Inclusion Criteria:

1. Males or females aged 18-80 years;
2. Meeting the 2023 ADA diagnostic criteria for type 2 diabetes;
3. 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;
4. 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:
5. Toronto Clinical Scoring System (TCSS) score ≥9;
6. Inadequate response to conventional therapy: Persistent symptoms (reduction of TCSS score \<2 points from baseline) despite ≥3 months of conventinal treatment;
7. Capacity to understand and voluntarily complete all study procedures and interventions, with signed informed consent.

Exclusion Criteria:

1. Non-diabetic neuropathy or pain conditions in lower limbs that may confound DPN assessment per investigator's judgment;
2. Poorly controlled diabetes (HbA1c \>12%);
3. 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;
4. Known allergy to stem cells, stem cell-derived products, or components of stem cell preparations;
5. Current use of prohibited medications within 5 half-lives prior to enrollment (may be reconsidered after ≥5 half-lives washout);
6. 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);
7. Clinically significant arrhythmia on 12-lead ECG;
8. Conditions requiring amputation (e.g., severe diabetic foot or lower limb ulcers) that preclude local stem cell injection;
9. Other diseases unsuitable for trial participation (e.g., active malignancy, cognitive impairment, depression, or psychiatric disorders);
10. Participation in any interventional clinical trial within 3 months prior to screening;
11. Pregnancy, lactation, or planning pregnancy within 2 years;
12. Any other condition deemed by the investigator to compromise trial suitability.

Where this trial is running

Chongqing, Chongqing Municipality

• Southwest Hospital — Chongqing, Chongqing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Min Long

Conditions Diabetic Peripheral Neuropathy; Mesenchymal Stem Cell Transplantation; Randomized Controlled Trial