Treatment With Human Umbilical Cord Mesenchymal Stem Cells for Refractory Diabetic Peripheral Neuropathy

NCT05507697 | Unknown Phase 1

• 1 other identifier: WuhanCH
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Peripheral Neuropathy Type 2

Keywords

Diabetic Peripheral Neuropathy; Stem Cell; TCSS; Type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (2)

• Change of TCSS scale

  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 from Baseline TCSS scale at week 24

• Change of nerve conduction velocities in the lower extremity

  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.

  Change from Baseline nerve conduction velocities in the lower extremity at week 12

Secondary Outcomes (4)

• Change of serum inflammatory factors

  Baseline, week 4, week 12, week 24, week 36, week 48, week 96

• Change of growth factors (GF)

  Baseline, week 4, week 12, week 24, week 36, week 48, week 96

• Change of fasting plasma glucose (FPG)

  Baseline, week 12, week 24, week 36, week 48, week 96

• Change of glycosylated hemoglobin (HbA1c)

  Baseline, week 12, week 24, week 36, week 48, week 96

Study Arms (2)

Experimental

EXPERIMENTAL

MSCs Participants will received i. m. HUC-MSCs both lower extremities

Biological: HUC-MSCs

Comparator

PLACEBO COMPARATOR

The control group will receive i.v Lipoic Acid Injection

Biological: Lipoic Acid

Interventions

HUC-MSCs BIOLOGICAL

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

Experimental

Lipoic Acid BIOLOGICAL

Lipoic Acid Injection，600 mg/d for 15 consecutive days

Comparator

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%;

You may not qualify if:

• 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

Sponsors & Collaborators

• Wuhan Central Hospital: lead
• Wuhan Optics Valley Vcanbio Cell & Gene Technology Co., Ltd., Hubei, China: collaborator
• Wuhan Optics Valley Zhongyuan Pharmaceutical Co., Ltd., Hubei, China: collaborator

Study Sites (1)

The Central Hospital of Wuhan

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• SHI ZHAO

  Wuhan Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

WEI WEI

CONTACT

+8615927268614; vivi880614@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, Clinical Professor

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 19, 2022
• Study Start: May 19, 2022
• Primary Completion: May 18, 2024
• Study Completion: May 31, 2024
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)