The Peripheral Mobilized Mononuclear Cell-based Therapy in Patient With Diabetic Neuropathy

Seoul National University Hospital

Overview

To investigate the efficacy and safety of autologous peripheral blood stem cell based therapy in patients with diabetic painful neuropathy.

Diabetic painful neuropathy a prevalent, disabling disorder. Currently, the only effective treatments are glucose control and pain management. Diabetic neuropathy is characterized by reduction of vascularity in peripheral nerves and deficiency in neurotrophic and angiogenic factors. Recent studies have shown that bone marrow (BM)-derived stem or progenitor cells have favorable effects on the repair of cardiovascular diseases. Since these BM-derived stem or progenitor cells contain various angiogenic and neurotrophic factors, these cells have been attempted for treating experimental diabetic neuropathy, and turned out to be effective for reversing various manifestations of experimental diabetic neuropathy. However, stem-cell therapy was not proven in human study. Therefore, we will investigate the efficacy and safety of autologous peripheral blood stem cell injection in diabetic neuropathy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Diabetic Neuropathy

Interventions

Normal salineBIOLOGICAL

Normal saline is injected in one leg of patient.

stem-cellBIOLOGICAL

Granulocyte colony-stimulating factor (G-CSF) is injected into subcutaneous for three days prior to the blood collection (D-3 to D-1). Peripheral mononuclear stem-cell is collected by Cobe spectra apheresis system in D-day. The stem-cell (mononuclear cell) is injected into the muscle in the other side leg of patient.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * symptomatic diabetic neuropathy moderate pain more than 3 months Michigan Neuropathy Screening Instrument (MNSI) \>3 3/day mean pain scale \> NRS 4 Body weight \>50 kg systolic blood pressure: 90-150 mmHg, Diastolic blood pressure \<100 mmHg, Body temperature \<37.5℃, Pulse rate: 50-100/min Exclusion Criteria: * other cause of neuropathy symptomatic peripheral vessel disease skin lesion or arthritis central neuronal disease drug addiction or abuse Aspartate aminotransferase or Alanine aminotransferase \>1.5 times than upper normal limit range Creatinine clearance rate \<60ml/min or dialysis Myocardial infarction, unstable angina or heart failure diagnosed in 3 months psychologic disorder pregnancy or lactation

Locations (1)

SeoulNUH

Seoul, South Korea

Outcomes

Primary Outcomes

Changes in pain for a week after the procedure

The pain scale was calculate by Numeric rating scale (NRS). We observe a change in NRS pain scores during the follow-up period.

Time frame: baseline, 4 week, 12 week

Secondary Outcomes

The evaluation of changes in the specific neuro-sensory system

The following tests was evaluated during the follow-up period. The pain intensity was evaluated by short-form McGill Pain Questionnaire and by sleep disturbance pain score. The quantitative change of sensory nerve was evaluated by quantitative sensory test (QST). We measure serum neuron-specific enolase (NSE), glucose, insulin and c-peptide. The amount of drug requirements will also assess at each follow-up period.

Time frame: baseline, 4 week, 12 week

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.