Diabetic Peripheral Neuropathy (DPN)Phase 2RELEASE-DPNNCT07183761
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
A Phase 2 study testing Experimental Group and Conventional therapy group in people with Diabetic Peripheral Neuropathy (DPN), run by Min Long at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy (DPN)
- What is being tested?
- Experimental Group and Conventional therapy group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 30 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Southwest Hospital
Chongqing, Chongqing Municipality, 400038
Xiaohuang Du, 023-68752086, 26980372@qq.com
About this study
Official title: A Randomized Controlled Trial Evaluating the Efficacy and Safety of Intramuscular Human Umbilical Cord Mesenchymal Stem Cell Therapy for Subjects With Moderate to Severe Diabetic Peripheral Neuropathy
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)
- Being tested
- Experimental Group, Conventional therapy group
- Keywords
- Diabetic Peripheral Neuropathy, Mesenchymal Stem Cell Transplantation, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupBiological
Also called human umbilical cord mesenchymal stem cells (hUC-MSCs) injection
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 groupDrug
Also called Conventional therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Experimental Group; Drug: Conventional therapy group |
| Control group | Active comparator | The control group will receive conventional therapy only. Receives: Drug: Conventional therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to week 24 of the study period
Incidence of stem cell-related adverse events
Safety endpoints
Measured: From enrollment to week 104 of the study period
Incidence of stem cell-associated adverse reactions
Safety endpoints
Measured: From enrollment to week 104 of the study period
Secondary outcomes (6)
Nerve conduction velocity
Evaluated using electrophysiological studies to measure nerve conduction function
Measured: From enrollment to week 24 of the study period
Quantitative Sensory Testing
Assess the participants' perception of temperature, vibration, and tactile sensations.
Measured: From enrollment to week 24 of the study period
Pain Score
Assess the participants' pain score using visual analog scale (VAS).
Measured: From enrollment to week 24 of the study period
Neuropathic pain
DN4 Neuropathic Pain Questionnaire
Measured: From enrollment to week 24 of the study period
Health-related quality of life
EuroQol Five-Dimensional Five-Level Questionnaire (EQ-5D-5L)
Measured: From enrollment to week 24 of the study period
Anxiety and Depression Scale
Hospital Anxiety and Depression Scale (HADS)
Measured: From enrollment to week 24 of the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Oct 2025
- Primary completion1 Apr 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral Neuropathy (DPN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min Long
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Min Long, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183761
- Sponsor's protocol ID
- 2023ZD0509004-4.1
- Acronym
- RELEASE-DPN
- Status last verified
- Apr 2026
- First submitted
- 14 Sep 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating the Efficacy and Safety of Intramuscular Human Umbilical Cord Mesenchymal Stem Cell Therapy for Subjects With Moderate to Severe Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07183761
- Acronym / sponsor ID
- RELEASE-DPN / 2023ZD0509004-4.1
- Conditions
- Diabetic Peripheral Neuropathy (DPN)
- Keywords
- Diabetic Peripheral Neuropathy, Mesenchymal Stem Cell Transplantation, Randomized Controlled Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Min LongUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Biological: Experimental Group, Drug: Conventional therapy groupThe experimental group will receive three injections of hUC-MSCs (on Day 0, Day 7, and Day 28) while continuing conventional therapy. |
| Control group | Active comparator | Drug: Conventional therapy groupThe control group will receive conventional therapy only. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental GroupAlso: human umbilical cord mesenchymal stem cells (hUC-MSCs) injectionOn 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. | Biological | Experimental group |
| Conventional therapy groupAlso: Conventional therapyThe 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. | Drug | Control group, Experimental group |
Primary outcome
Toronto Clinical Scoring System (TCSS) score
Time frame: From enrollment to week 24 of the study period
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.
Incidence of stem cell-related adverse events
Time frame: From enrollment to week 104 of the study period
Safety endpoints
Incidence of stem cell-associated adverse reactions
Time frame: From enrollment to week 104 of the study period
Safety endpoints
6 secondary outcomes
Nerve conduction velocity
Time frame: From enrollment to week 24 of the study period
Quantitative Sensory Testing
Time frame: From enrollment to week 24 of the study period
Pain Score
Time frame: From enrollment to week 24 of the study period
Neuropathic pain
Time frame: From enrollment to week 24 of the study period
Health-related quality of life
Time frame: From enrollment to week 24 of the study period
Anxiety and Depression Scale
Time frame: From enrollment to week 24 of the study period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Experimental Group and Conventional therapy group in people with Diabetic Peripheral Neuropathy (DPN), run by Min Long at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Long (+862368765431, longmin_casper@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toronto Clinical Scoring System (TCSS) score (time frame: From enrollment to week 24 of the study period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026; AzTrials last refreshed its copy on 3 Nov 2026.