Diabetic Peripheral Neuropathy Type 2Phase 1/2NCT05507697
Treatment With Human Umbilical Cord Mesenchymal Stem Cells for Refractory Diabetic Peripheral Neuropathy
A Phase 1/2 study testing HUC-MSCs and Lipoic Acid in people with Diabetic Peripheral Neuropathy Type 2, run by Wuhan Central Hospital at 1 site in China.
Trial summary
Diabetic Peripheral Neuropathy (DPN) is one of the most common chronic complications in type 2 diabetes, conventional drug therapy can only target a single pathogenesis but not treat Diabetic Peripheral Neuropathy (DPN) fundamentally. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy Type 2
- What is being tested?
- HUC-MSCs and Lipoic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 19 May 2022to 31 May 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages at 18-55 years (including 18 and 55 years), regardless of gender;
- Understand and sign the ICF before proceeding with any steps related to this study, comply with the requirements, and do not to participate in other clinical studies during this research;
- T2DM patients defined by the 2013 American Diabetes Association (ADA) standards;
- Meet the diagnostic criteria for diabetic peripheral neuropathy: ① A clear history of diabetes; ② Neuropathy that occurs on or after the diagnosis of diabetes; ③Clinical symptoms and signs are consistent with DPN; ④ People with clinical symptoms (pain, numbness, abnormal sensation, etc.), had any 1 of the 5 items of ankle reflex, acupuncture pain, vibration, pressure and temperature in abnormal; people without clinical symptoms had any 2 of the 5 items were abnormal;
- The evaluation of symptoms and signs of neuropathy is at severe level (TCSS score ≥12);
- For conventional standard drug treatment (combined use of Lipoic Acid Capsules, Methyl cobalamin Tablets, and Epalrestat Tablets) at least 6 months and TCSS score decrease ≤30%;
Who cannot join
- Diseases that the investigator believes that it may interfere with subject compliance, including any uncontrolled diseases like in urinary, circulatory, respiratory, nervous, mental, digestive, endocrine, immune, and other system;
- Pregnant women, breastfeeding women or those who have a childbearing plan soon;
- Patients who are known to be allergic to cell products;
- People with various types of malignancies or hematological diseases;
- Complicated with severe lower extremity arterial disease (ankle-brachial index < 0.9)
- Complicated with foot ulcers, infections, or lower extremity amputation;
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- Combined with neuropathy caused by other causes, such as lumbar spondylosis, cerebral infarction, Guillain-Barre Syndrome, excluding severe arteriovenous vascular disease, application of some chemotherapy drugs or renal insufficiency, etc. Nerve damage disease;
- Those who are unable or unwilling to provide informed consent or fail to comply with research requirements;
- Participated in other stem cell clinical researches before enrollment;
- Participated in other clinical trials within 3 months before enrollment.
- Patients with positive serum HIV antibodies;
- Patients with a history of alcohol and drug abuse and failed to abstain effectively
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Central Hospital of Wuhan
Wuhan, Hubei
Shi Zhao, +86 13707172291, zhaoshiwuhan@126.com
About this study
Official title: Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Refractory Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN) is one of the most common chronic complications in type 2 diabetes, conventional drug therapy can only target a single pathogenesis but not treat Diabetic Peripheral Neuropathy (DPN) fundamentally. As a novel technique, stem cell transplantation provides a new option for patients with DPN. In 2012, Wuhan Central Hospital, took the lead in carrying out clinical research on the treatment of DPN with autologous bone marrow stem cells in China, and patients were significantly relieved. Based on this research, our clinical trial is to evaluate the safety and efficacy of HUC-MSCs in the treatment of refractory diabetic peripheral neuropathy (DPN) by formulating standard operating procedures (SOP) and quality standards (QS) to explore the possible mechanism of HUC-MSCs in the treatment of DPN.
Read the detailed description
As Diabetes is becoming a health problem of global concern rapidly, DPN, one of the common chronic complications in Diabetes is also getting more and more attention. The result of a survey of 5 regions in Southeast Asia showed that 39-72% of patients with DPN had severe or very severe impact on their quality of life. For the treatment of DPN, conventional drug therapy can almost only target a single pathogenesis and cannot treat it fundamentally. Therefore, new safe and effective treatment options for DPN are particularly important.
Both here and abroad, large number of experimental studies have shown that Bone Marrow or Umbilical Cord Mesenchymal Stem Cells have a significant therapeutic effect on diabetic peripheral neuropathy. In 2012, the Department of Endocrinology of Wuhan Central Hospital took the lead in conducting a clinical study of Autologous Bone Marrow Stem Cells in the treatment of DPN in China. The results of the study showed that the nerve conduction velocity of the lower extremities in most patients was improved within 3 months after treatment compared with before treatment. No serious adverse events occurred during the period. Based on this research of our own. The clinical trial is to evaluate the safety and efficacy of HUC-MSCs in the treatment of refractory diabetic peripheral neuropathy (DPN) by formulating standard operating procedures (SOP) and quality standards (QS) to explore the possible mechanism of HUC-MSCs in the treatment of DPN.
The investigators will do a Single center, randomization, open trial, controlled clinical trials design to assess treatment with the MSCs compared with the control group. 42 patients with DPN will be recruited in China. 21 patients receive i. m. HUC-MSCs both lower extremities (5 × 10^6 cells/mL, 1 mL per injection, each injection point is 2 cm apart ,1.0-1.5 cm deep, total amount of injection is estimated based on the surface area of the patient's lower limbs). 21 patients in the control group received i.v. Lipoic Acid Injection (600 mg/d for 15 consecutive days). Both efficacy and Adverse Event (AE) during the 96 weeks follow up.
- Conditions
- Diabetic Peripheral Neuropathy Type 2
- Being tested
- HUC-MSCs, Lipoic Acid
- Keywords
- Diabetic Peripheral Neuropathy, Stem Cell, TCSS, Type 2 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HUC-MSCsBiological
5 × 10^6 cells/mL, 1 mL per injection, each injection point is 2 cm apart ,1.0-1.5 cm deep, total amount of injection is estimated based on the surface area of the patient's lower limb
Lipoic AcidBiological
Lipoic Acid Injection，600 mg/d for 15 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | MSCs Participants will received i. m. HUC-MSCs both lower extremities Receives: Biological: HUC-MSCs |
| Comparator | Placebo comparator | The control group will receive i.v Lipoic Acid Injection Receives: Biological: Lipoic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of TCSS scale
- Excellent: TCSS score decreased by >30% compared with the baseline value after treatment;
- Effective: TCSS score decreased by 30%-15% compared with the baseline value after treatment;
- Ineffective: Those who did not achieve the standards above after treatment.
Measured: Change from Baseline TCSS scale at week 24
Change of nerve conduction velocities in the lower extremity
- Excellent: after treatment, the lower extremity nerve conduction velocity and amplitude increased by more than 15% compared with the baseline value;
- Effective: after treatment, the lower extremity nerve conduction velocity and amplitude increased by 15%-5% compared with the baseline value;
- Ineffective: Those who did not achieve the standards above after treatment.
Measured: Change from Baseline nerve conduction velocities in the lower extremity at week 12
Secondary outcomes (4)
Change of serum inflammatory factors
Observe the changes during the study period
Measured: Baseline, week 4, week 12, week 24, week 36, week 48, week 96
Change of growth factors (GF)
Observe the changes during the study period
Measured: Baseline, week 4, week 12, week 24, week 36, week 48, week 96
Change of fasting plasma glucose (FPG)
Observe the changes during the study period
Measured: Baseline, week 12, week 24, week 36, week 48, week 96
Change of glycosylated hemoglobin (HbA1c)
Observe the changes during the study period
Measured: Baseline, week 12, week 24, week 36, week 48, week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start19 May 2022
- Primary completion18 May 2024 (estimated)
- Study completion31 May 2024 (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 Type 2Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Optics Valley Vcanbio Cell & Gene Technology Co., Ltd., Hubei, China, Wuhan Optics Valley Zhongyuan Pharmaceutical Co., Ltd., Hubei, China
- Responsible party
- Principal investigator, Shi Zhao, Wuhan Central Hospital
- Investigators
- SHI ZHAO, Principal investigator, Wuhan Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507697
- Sponsor's protocol ID
- WuhanCH
- Status last verified
- Aug 2022
- First submitted
- 12 Aug 2022
- Last updated
- 19 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After approval from the steering committee and the Human Genetic Resources Administration of China, this trial data can be shared with qualifying researchers who submit a proposal with a valuable research question. A contract should be signed.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Refractory Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT05507697
- Acronym / sponsor ID
- WuhanCH
- Conditions
- Diabetic Peripheral Neuropathy Type 2
- Keywords
- Diabetic Peripheral Neuropathy, Stem Cell, TCSS, Type 2 diabetes mellitus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Wuhan Central HospitalUniversity, hospital or other
- Collaborators
- Wuhan Optics Valley Vcanbio Cell & Gene Technology Co., Ltd., Hubei, China, Wuhan Optics Valley Zhongyuan Pharmaceutical Co., Ltd., Hubei, China
- Study start
- 19 May 2022 (actual)
- Primary completion
- 18 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 19 Aug 2022 (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.
Diabetic Peripheral Neuropathy (DPN) is one of the most common chronic complications in type 2 diabetes, conventional drug therapy can only target a single pathogenesis but not treat Diabetic Peripheral Neuropathy (DPN) fundamentally. As a novel technique, stem cell transplantation provides a new option for patients with DPN. In 2012, Wuhan Central Hospital, took the lead in carrying out clinical research on the treatment of DPN with autologous bone marrow stem cells in China, and patients were significantly relieved. Based on this research, our clinical trial is to evaluate the safety and efficacy of HUC-MSCs in the treatment of refractory diabetic peripheral neuropathy (DPN) by formulating standard operating procedures (SOP) and quality standards (QS) to explore the possible mechanism of HUC-MSCs in the treatment of DPN.
Detailed description
As Diabetes is becoming a health problem of global concern rapidly, DPN, one of the common chronic complications in Diabetes is also getting more and more attention. The result of a survey of 5 regions in Southeast Asia showed that 39-72% of patients with DPN had severe or very severe impact on their quality of life. For the treatment of DPN, conventional drug therapy can almost only target a single pathogenesis and cannot treat it fundamentally. Therefore, new safe and effective treatment options for DPN are particularly important.
Both here and abroad, large number of experimental studies have shown that Bone Marrow or Umbilical Cord Mesenchymal Stem Cells have a significant therapeutic effect on diabetic peripheral neuropathy. In 2012, the Department of Endocrinology of Wuhan Central Hospital took the lead in conducting a clinical study of Autologous Bone Marrow Stem Cells in the treatment of DPN in China. The results of the study showed that the nerve conduction velocity of the lower extremities in most patients was improved within 3 months after treatment compared with before treatment. No serious adverse events occurred during the period. Based on this research of our own. The clinical trial is to evaluate the safety and efficacy of HUC-MSCs in the treatment of refractory diabetic peripheral neuropathy (DPN) by formulating standard operating procedures (SOP) and quality standards (QS) to explore the possible mechanism of HUC-MSCs in the treatment of DPN.
The investigators will do a Single center, randomization, open trial, controlled clinical trials design to assess treatment with the MSCs compared with the control group. 42 patients with DPN will be recruited in China. 21 patients receive i. m. HUC-MSCs both lower extremities (5 × 10^6 cells/mL, 1 mL per injection, each injection point is 2 cm apart ,1.0-1.5 cm deep, total amount of injection is estimated based on the surface area of the patient's lower limbs). 21 patients in the control group received i.v. Lipoic Acid Injection (600 mg/d for 15 consecutive days). Both efficacy and Adverse Event (AE) during the 96 weeks follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Biological: HUC-MSCsMSCs Participants will received i. m. HUC-MSCs both lower extremities |
| Comparator | Placebo comparator | Biological: Lipoic AcidThe control group will receive i.v Lipoic Acid Injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ages at 18-55 years (including 18 and 55 years), regardless of gender;
- Understand and sign the ICF before proceeding with any steps related to this study, comply with the requirements, and do not to participate in other clinical studies during this research;
- T2DM patients defined by the 2013 American Diabetes Association (ADA) standards;
- Meet the diagnostic criteria for diabetic peripheral neuropathy: ① A clear history of diabetes; ② Neuropathy that occurs on or after the diagnosis of diabetes; ③Clinical symptoms and signs are consistent with DPN; ④ People with clinical symptoms (pain, numbness, abnormal sensation, etc.), had any 1 of the 5 items of ankle reflex, acupuncture pain, vibration, pressure and temperature in abnormal; people without clinical symptoms had any 2 of the 5 items were abnormal;
- The evaluation of symptoms and signs of neuropathy is at severe level (TCSS score ≥12);
Key exclusion criteria (12 listed)
- Diseases that the investigator believes that it may interfere with subject compliance, including any uncontrolled diseases like in urinary, circulatory, respiratory, nervous, mental, digestive, endocrine, immune, and other system;
- Pregnant women, breastfeeding women or those who have a childbearing plan soon;
- Patients who are known to be allergic to cell products;
- People with various types of malignancies or hematological diseases;
- Complicated with severe lower extremity arterial disease (ankle-brachial index < 0.9)
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 |
|---|---|---|
| HUC-MSCs5 × 10^6 cells/mL, 1 mL per injection, each injection point is 2 cm apart ,1.0-1.5 cm deep, total amount of injection is estimated based on the surface area of the patient's lower limb | Biological | Experimental |
| Lipoic AcidLipoic Acid Injection，600 mg/d for 15 consecutive days | Biological | Comparator |
Primary outcome
Change of TCSS scale
Time frame: Change from Baseline TCSS scale at week 24
1. Excellent: TCSS score decreased by >30% compared with the baseline value after treatment; 2. Effective: TCSS score decreased by 30%-15% compared with the baseline value after treatment; 3. Ineffective: Those who did not achieve the standards above after treatment.
Change of nerve conduction velocities in the lower extremity
Time frame: Change from Baseline nerve conduction velocities in the lower extremity at week 12
1. Excellent: after treatment, the lower extremity nerve conduction velocity and amplitude increased by more than 15% compared with the baseline value; 2. Effective: after treatment, the lower extremity nerve conduction velocity and amplitude increased by 15%-5% compared with the baseline value; 3. Ineffective: Those who did not achieve the standards above after treatment.
4 secondary outcomes
Change of serum inflammatory factors
Time frame: Baseline, week 4, week 12, week 24, week 36, week 48, week 96
Change of growth factors (GF)
Time frame: Baseline, week 4, week 12, week 24, week 36, week 48, week 96
Change of fasting plasma glucose (FPG)
Time frame: Baseline, week 12, week 24, week 36, week 48, week 96
Change of glycosylated hemoglobin (HbA1c)
Time frame: Baseline, week 12, week 24, week 36, week 48, week 96
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Individual participant dataSharing planned: Yes. After approval from the steering committee and the Human Genetic Resources Administration of China, this trial data can be shared with qualifying researchers who submit a proposal with a valuable research question. A contract should be signed.
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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. This study is not recruiting at the moment.
SHI ZHAO principal investigator
Wuhan Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HUC-MSCs and Lipoic Acid in people with Diabetic Peripheral Neuropathy Type 2, run by Wuhan Central Hospital 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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 19 Aug 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact WEI WEI (+8615927268614, vivi880614@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of TCSS scale (time frame: Change from Baseline TCSS scale at week 24). The study lists 2 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 19 Aug 2022.