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Tests treatment safety and results for Diabetic Peripheral Neuropathy (DPN)
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
ClinicalTrials.gov ID: NCT07183761
What this study is testing
What is Experimental Group?
Experimental Group is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for diabetic peripheral neuropathy (dpn).
Also referred to as human umbilical cord mesenchymal stem cells (hUC-MSCs) injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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...
- Confirmed neurophysiological dysfunction: Reduced nerve conduction velocity (≥2 standard deviations) in at least one lower extremity nerve (common...
- Toronto Clinical Scoring System (TCSS) score ≥9;
You likely can't join 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 \ 3× upper limit of...
- 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...
See the full eligibility criteria
- 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...
- 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...
- 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.
- 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 \ 3× upper limit of normal (ULN), or total bilirubin \>1.5× ULN; Renal function: eGFR \ 2×...
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.