Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2026-02-20 @ 6:41 PM
Study NCT ID:
NCT02315235
Status:
WITHDRAWN
Last Update Posted:
2016-04-15
First Post:
2014-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Peripheral Mobilized Mononuclear Cell-based Therapy in Patient With Diabetic Neuropathy
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
The Efficacy and Safety of Peripheral Mobilized Mononuclear Cell-based Therapy in Patients With Diabetic Painful Neuropathy
Status:
WITHDRAWN
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Do not have a sutable subjects.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: