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

August 16, 2022 updated by: Shi Zhao, Wuhan Central Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • The Central Hospital of Wuhan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
MSCs Participants will received i. m. HUC-MSCs both lower extremities
Biological: HUC-MSCs
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
Placebo Comparator: Comparator
The control group will receive i.v Lipoic Acid Injection
Biological: Lipoic Acid
Lipoic Acid Injection，600 mg/d for 15 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 from Baseline TCSS scale at week 24
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.
Change from Baseline nerve conduction velocities in the lower extremity at week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of serum inflammatory factors
Time Frame: Baseline, week 4, week 12, week 24, week 36, week 48, week 96
Observe the changes during the study period
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
Observe the changes during the study period
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
Observe the changes during the study period
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
Observe the changes during the study period
Baseline, week 12, week 24, week 36, week 48, week 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Central Hospital

Collaborators

Wuhan Optics Valley Zhongyuan Pharmaceutical Co., Ltd., Hubei, China
Wuhan Optics Valley Vcanbio Cell & Gene Technology Co., Ltd., Hubei, China

Investigators

  • Principal Investigator: SHI ZHAO, Wuhan Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2022

Primary Completion (Anticipated)

May 18, 2024

Study Completion (Anticipated)

May 31, 2024

Study Registration Dates

First Submitted

August 12, 2022

First Submitted That Met QC Criteria

August 16, 2022

First Posted (Actual)

August 19, 2022

Study Record Updates

Last Update Posted (Actual)

August 19, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WuhanCH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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