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

NCT02315235 | Withdrawn DMC

• 1 other identifier: mononuclear cell-based therapy
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, 4 week, 12 week

Secondary Outcomes (1)

• The evaluation of changes in the specific neuro-sensory system

  baseline, 4 week, 12 week

Other Outcomes (1)

• The secondary effect of the procedure for the peripheral nerves and blood vessels

  baseline, 12 week

Study Arms (2)

control

ACTIVE COMPARATOR

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.

Biological: Normal saline

stem cell (mononuclear cell)

ACTIVE COMPARATOR

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.

Biological: stem-cell

Interventions

Normal saline BIOLOGICAL

Normal saline is injected in one leg of patient.

control

stem-cell 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.

stem cell (mononuclear cell)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

SeoulNUH

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Hye Seung Jung, Ph.D.

  Seoul Nation University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 11, 2014
• Study Start: May 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 15, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)