Actively 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
Led by Min Long · Updated on 2026-04-23
140
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18-80 years
- Diagnosed with type 2 diabetes according to 2023 ADA criteria
- Presence of symptoms and signs of diabetic neuropathy in lower limbs, including abnormal ankle reflex, pinprick sensation, vibration sense, pressure perception, or temperature sensation
- Confirmed nerve dysfunction with reduced nerve conduction velocity in at least one lower leg nerve
- Moderate to severe neuropathy with Toronto Clinical Scoring System (TCSS) score of 9 or higher
- Symptoms persist despite at least 3 months of conventional therapy with less than 2-point improvement in TCSS score
- Ability to understand and voluntarily complete study procedures with signed informed consent
You will not qualify if you...
- Neuropathy or pain in lower limbs from causes other than diabetes as judged by investigator
- Poorly controlled diabetes with HbA1c over 12%
- Severe blood, liver, or kidney problems including low neutrophils, platelets, hemoglobin, high liver enzymes or bilirubin, low kidney function, or need for dialysis
- Known allergy to stem cells or related products
- Use of prohibited medications within 5 half-lives before enrollment
- Uncontrolled infections, autoimmune diseases, blood disorders, or severe heart failure (NYHA class III or higher)
- Significant irregular heartbeats on ECG
- Conditions requiring limb amputation or severe ulcers preventing stem cell injections
- Other diseases making participation unsuitable such as active cancer, cognitive or psychiatric disorders
- Participation in another interventional clinical trial within 3 months
- Pregnancy, breastfeeding, or planning pregnancy within 2 years
- Any other condition deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Southwest Hospital
Chongqing, Chongqing Municipality, China, 400038
Actively Recruiting
Research Team
M
Min Long
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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