Back to resultsTreatment With Human Umbilical Cord Mesenchymal Stem Cells for Refractory Diabetic Peripheral Neuropathy
Primary Purpose
Diabetic Peripheral Neuropathy Type 2
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HUC-MSCs
Lipoic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Peripheral Neuropathy Type 2 focused on measuring Diabetic Peripheral Neuropathy, Stem Cell, TCSS, Type 2 diabetes mellitus
Eligibility Criteria
Inclusion Criteria:
- 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%;
Exclusion Criteria:
- 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;
- 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
Sites / Locations
- The Central Hospital of WuhanRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental
Comparator
Arm Description
MSCs Participants will received i. m. HUC-MSCs both lower extremities
The control group will receive i.v Lipoic Acid Injection
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Change of serum inflammatory factors
Observe the changes during the study period
Change of growth factors (GF)
Observe the changes during the study period
Change of fasting plasma glucose (FPG)
Observe the changes during the study period
Change of glycosylated hemoglobin (HbA1c)
Observe the changes during the study period
Full Information
NCT ID
NCT05507697
First Posted
August 12, 2022
Last Updated
August 16, 2022
Sponsor
Wuhan Central Hospital
Collaborators
Wuhan Optics Valley Vcanbio Cell & Gene Technology Co., Ltd., Hubei, China, Wuhan Optics Valley Zhongyuan Pharmaceutical Co., Ltd., Hubei, China
1. Study Identification
Unique Protocol Identification Number
NCT05507697
Brief Title
Treatment With Human Umbilical Cord Mesenchymal Stem Cells for Refractory Diabetic Peripheral Neuropathy
Official Title
Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Refractory Diabetic Peripheral Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2022 (Actual)
Primary Completion Date
May 18, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan Central Hospital
Collaborators
Wuhan Optics Valley Vcanbio Cell & Gene Technology Co., Ltd., Hubei, China, Wuhan Optics Valley Zhongyuan Pharmaceutical Co., Ltd., Hubei, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy Type 2
Keywords
Diabetic Peripheral Neuropathy, Stem Cell, TCSS, Type 2 diabetes mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
MSCs Participants will received i. m. HUC-MSCs both lower extremities
Arm Title
Comparator
Arm Type
Placebo Comparator
Arm Description
The control group will receive i.v Lipoic Acid Injection
Intervention Type
Biological
Intervention Name(s)
HUC-MSCs
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Lipoic Acid
Intervention Description
Lipoic Acid Injection，600 mg/d for 15 consecutive days
Primary Outcome Measure Information:
Title
Change of TCSS scale
Description
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.
Time Frame
Change from Baseline TCSS scale at week 24
Title
Change of nerve conduction velocities in the lower extremity
Description
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.
Time Frame
Change from Baseline nerve conduction velocities in the lower extremity at week 12
Secondary Outcome Measure Information:
Title
Change of serum inflammatory factors
Description
Observe the changes during the study period
Time Frame
Baseline, week 4, week 12, week 24, week 36, week 48, week 96
Title
Change of growth factors (GF)
Description
Observe the changes during the study period
Time Frame
Baseline, week 4, week 12, week 24, week 36, week 48, week 96
Title
Change of fasting plasma glucose (FPG)
Description
Observe the changes during the study period
Time Frame
Baseline, week 12, week 24, week 36, week 48, week 96
Title
Change of glycosylated hemoglobin (HbA1c)
Description
Observe the changes during the study period
Time Frame
Baseline, week 12, week 24, week 36, week 48, week 96
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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%;
Exclusion Criteria:
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;
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
WEI WEI
Phone
+8615927268614
Email
vivi880614@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SHI ZHAO
Organizational Affiliation
Wuhan Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Central Hospital of Wuhan
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shi Zhao
Phone
+86 13707172291
Email
zhaoshiwuhan@126.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Learn more about this trial
Treatment With Human Umbilical Cord Mesenchymal Stem Cells for Refractory Diabetic Peripheral Neuropathy
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