Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
Min Long
Conditions:
Diabetic Peripheral Neuropathy (DPN)
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 ne...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2028
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT07183761
Start Date
October 1 2025
End Date
August 30 2028
Last Update
September 19 2025
Active Locations (1)
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1
Southwest Hospital
Chongqing, Chongqing Municipality, China, 400038