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

NCT07183761 | Recruiting Phase 2

• 1 other identifier: 2023ZD0509004-4.1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Toronto Clinical Scoring System (TCSS) score

  The TCSS is a method for assessing neurological function. It evaluates patients based on their symptoms, reflexes, and sensory test results to determine whether neurological impairment exists.

  From enrollment to week 24 of the study period

• Incidence of stem cell-related adverse events

  Safety endpoints

  From enrollment to week 104 of the study period

• Incidence of stem cell-associated adverse reactions

  Safety endpoints

  From enrollment to week 104 of the study period

Secondary Outcomes (6)

• Nerve conduction velocity

  From enrollment to week 24 of the study period

• Quantitative Sensory Testing

  From enrollment to week 24 of the study period

• Pain Score

  From enrollment to week 24 of the study period

• Neuropathic pain

  From enrollment to week 24 of the study period

• Health-related quality of life

  From enrollment to week 24 of the study period

Other Outcomes (4)

• Lower extremity blood flow velocity

  From enrollment to week 24 of the study period

• Microstructure of nerve fascicles

  At enrollment and week 24 of the study period

• Immune-inflammatory markers

  At enrollment and week 24 of the study period

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group will receive three injections of hUC-MSCs (on Day 0, Day 7, and Day 28) while continuing conventional therapy.

Biological: Experimental Group; Drug: Conventional therapy group

Control group

ACTIVE COMPARATOR

The control group will receive conventional therapy only.

Drug: Conventional therapy group

Interventions

Experimental Group BIOLOGICAL

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.

Also known as: human umbilical cord mesenchymal stem cells (hUC-MSCs) injection

Experimental group

Conventional therapy group DRUG

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.

Also known as: Conventional therapy

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Non-diabetic neuropathy or pain conditions in lower limbs that may confound DPN assessment per investigator's judgment;
• Poorly controlled diabetes (HbA1c \>12%);
• 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;
• 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;
• Other diseases unsuitable for trial participation (e.g., active malignancy, cognitive impairment, depression, or psychiatric disorders);
• Participation in any interventional clinical trial within 3 months prior to screening;
• Pregnancy, lactation, or planning pregnancy within 2 years;
• Any other condition deemed by the investigator to compromise trial suitability.

Sponsors & Collaborators

• Min Long: lead

Study Sites (1)

Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Min Long

CONTACT

+862368765431; longmin_casper@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, Associate Chief Physician, Associate Professor

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: September 19, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): August 30, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

CN (1)