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

ConditionDiabetic Peripheral Neuropathy (DPN)

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-80

SponsorMin Long

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males or females aged 18-80 years;

Meeting the 2023 ADA diagnostic criteria for type 2 diabetes;

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;

Disqualifiers

Non-diabetic neuropathy or pain conditions in lower limbs that may confound DPN assessment per investigator's judgment;

Poorly controlled diabetes (HbA1c >12%);

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);

Trial design

Design model

Parallel

Treatments tested in this trial

Experimental Group
Biological/Vaccine
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.
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.

Treatment groups

140 Participants

are divided into 2 treatment groups

Group A: Experimental groupExperimental treatment 2 interventions

Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

From enrollment to week 24 of the study period

Incidence of stem cell-related adverse events

Safety endpoints

Time frame

From enrollment to week 104 of the study period

Incidence of stem cell-associated adverse reactions

Safety endpoints

Time frame

From enrollment to week 104 of the study period

Secondary outcomes

Nerve conduction velocity

Evaluated using electrophysiological studies to measure nerve conduction function

Time frame

From enrollment to week 24 of the study period

Quantitative Sensory Testing

Assess the participants' perception of temperature, vibration, and tactile sensations.

Time frame

From enrollment to week 24 of the study period

Pain Score

Assess the participants' pain score using visual analog scale (VAS).

Time frame

From enrollment to week 24 of the study period

Neuropathic pain

DN4 Neuropathic Pain Questionnaire

Time frame

From enrollment to week 24 of the study period

Other outcomes

Lower extremity blood flow velocity

Evaluated by lower limb vascular ultrasound

Time frame

From enrollment to week 24 of the study period

Microstructure of nerve fascicles

Evaluated by 7T MRI

Time frame

At enrollment and week 24 of the study period

Immune-inflammatory markers

Include erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), neutrophil-to-lymphocyte ratio (NLR), peripheral blood mononuclear cell subsets, and inflammation-related cytokines.

Time frame

At enrollment and week 24 of the study period

Status of lower extremity ulcers

The percentage of ulcer healing, along with the frequency and number of newly developed diabetic lower extremity ulcers

Time frame

At enrollment and week 104 of the study period