The Peripheral Mobilized Mononuclear Cell-based Therapy in Patient With Diabetic Neuropathy
Primary Purpose
Diabetic Neuropathy
Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Normal saline
stem-cell
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathy
Eligibility Criteria
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
Sites / Locations
- SeoulNUH
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
control
stem cell (mononuclear cell)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02315235
First Posted
December 5, 2014
Last Updated
April 14, 2016
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02315235
Brief Title
The Peripheral Mobilized Mononuclear Cell-based Therapy in Patient With Diabetic Neuropathy
Official Title
The Efficacy and Safety of Peripheral Mobilized Mononuclear Cell-based Therapy in Patients With Diabetic Painful Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Do not have a sutable subjects.
Study Start Date
May 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To investigate the efficacy and safety of autologous peripheral blood stem cell based therapy in patients with diabetic painful neuropathy.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
stem cell (mononuclear cell)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Normal saline
Intervention Description
Normal saline is injected in one leg of patient.
Intervention Type
Biological
Intervention Name(s)
stem-cell
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in pain for a week after the procedure
Description
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 Outcome Measure Information:
Title
The evaluation of changes in the specific neuro-sensory system
Description
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
Other Pre-specified Outcome Measures:
Title
The secondary effect of the procedure for the peripheral nerves and blood vessels
Description
Michigan neuropathy screening instrument (MNSI) is used for screening for diabetic peripheral neuropathy. Changes in patient's mood is assessed by the Beck Depression Inventory (BDI) system. Electrophysiological tests are used in the evaluation of nerve conduct velocity. Skin punch biopsy is used to evaluate the density of epidermal nerve fibers. Improvement of blood flow in the peripheral veins is evaluated by ankle brachial index (ABI), pulse wave velocity (PWV) and digital arterial plethysmography. We measure serum glucose, insulin ant c-peptide. The amount of drug requirements will also assess at each follow-up period.
Time Frame
baseline, 12 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hye Seung Jung, Ph.D.
Organizational Affiliation
Seoul Nation University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
SeoulNUH
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Peripheral Mobilized Mononuclear Cell-based Therapy in Patient With Diabetic Neuropathy
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