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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Diabetic Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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control

The operator inject normal saline(control) to thirty site of the other side leg of active comparator. The volume of one site injection is 0.5 ml. The depth of needle injection would be 1.5cm.

Group Type ACTIVE_COMPARATOR

Normal saline

Intervention Type BIOLOGICAL

Normal saline is injected in one leg of patient.

stem cell (mononuclear cell)

The stem cell (mononuclear cell) is injected to thirty site of one side leg in operating room after general anesthesia. The volume of one site injection is 0.5 to 1.0 ml. The depth of needle injection would be 1.5cm.

Group Type ACTIVE_COMPARATOR

stem-cell

Intervention Type BIOLOGICAL

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.

Interventions

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Normal saline

Normal saline is injected in one leg of patient.

Intervention Type BIOLOGICAL

stem-cell

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No