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

NCT05507697 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2022-08-19

No results posted yet for this study

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

Interventions

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

BIOLOGICAL

Lipoic Acid

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

Sponsors & Collaborators

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

    collaborator UNKNOWN

  • Wuhan Optics Valley Zhongyuan Pharmaceutical Co., Ltd., Hubei, China

    collaborator UNKNOWN

  • Wuhan Central Hospital

    lead OTHER

Principal Investigators

  • SHI ZHAO · Wuhan Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-19
Primary Completion
2024-05-18
Completion
2024-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05507697 on ClinicalTrials.gov