Diabetic Neuropathy Clinical Trial
Official title:
The Efficacy and Safety of Peripheral Mobilized Mononuclear Cell-based Therapy in Patients With Diabetic Painful Neuropathy
Verified date | April 2016 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
To investigate the efficacy and safety of autologous peripheral blood stem cell based therapy in patients with diabetic painful neuropathy.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | SeoulNUH | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The secondary effect of the procedure for the peripheral nerves and blood vessels | 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. | baseline, 12 week | Yes |
Primary | 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 | No |
Secondary | 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. | baseline, 4 week, 12 week | Yes |
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