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

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ClinicalTrials.gov Identifier: NCT02315235
Recruitment Status : Withdrawn (Do not have a sutable subjects.)
First Posted : December 11, 2014
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Hye Seung Jung, Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Diabetic Neuropathy Biological: Normal saline Biological: stem-cell Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Peripheral Mobilized Mononuclear Cell-based Therapy in Patients With Diabetic Painful Neuropathy
Study Start Date : May 2014
Actual Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

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Arm Intervention/treatment
Active Comparator: 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.
Biological: Normal saline
Normal saline is injected in one leg of patient.

Active Comparator: 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.
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.





Primary Outcome Measures :
  1. Changes in pain for a week after the procedure [ Time Frame: baseline, 4 week, 12 week ]
    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 :
  1. The evaluation of changes in the specific neuro-sensory system [ Time Frame: baseline, 4 week, 12 week ]
    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.


Other Outcome Measures:
  1. The secondary effect of the procedure for the peripheral nerves and blood vessels [ Time Frame: baseline, 12 week ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315235


Locations
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Korea, Republic of
SeoulNUH
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Chair: Hye Seung Jung, Ph.D. Seoul Nation University Hospital

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Responsible Party: Hye Seung Jung, Associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02315235     History of Changes
Other Study ID Numbers: mononuclear cell-based therapy
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases