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

Diabetic Neuropathy Clinical Trial

Official title:

The Efficacy and Safety of Peripheral Mobilized Mononuclear Cell-based Therapy in Patients With Diabetic Painful Neuropathy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02315235
• Other study ID #: mononuclear cell-based therapy
• Status: Withdrawn
• Phase: N/A
• First received: December 5, 2014
• Last updated: April 14, 2016
• Start date: May 2014
• Est. completion date: March 2016

Study information

• 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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy

Intervention

Biological:
• Normal saline
Normal saline is injected in one leg of patient.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	SeoulNUH	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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