NCT02315235

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Neuropathy

Interventions

Type	Name	Description
BIOLOGICAL	Normal saline	Normal saline is injected in one leg of patient.
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.

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2014-12-11
• Last updated: 2016-04-15

Locations

1 site across 1 country: South Korea