Viewing Study NCT04528550


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Study NCT ID: NCT04528550
Status: UNKNOWN
Last Update Posted: 2021-07-07
First Post: 2020-08-24
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Autologous Bone Marrow-derived Mononuclear Cells for Acute Spinal Cord Injury
Sponsor: Shanghai Changzheng Hospital
Organization:

Study Overview

Official Title: Intrathecal Transplantation of Autologous Bone Marrow-derived Mononuclear Cells for Treating Traumatic Acute Spinal Cord Injury
Status: UNKNOWN
Status Verified Date: 2021-07
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of intrathecal transplantation of autologous bone marrow-derived mononuclear cells for the treatment of traumatic acute spinal cord injury. Spinal cord injury can be divided into three phases, which are acute (within 2 weeks), sub-acute (2 weeks to 6 months), and chronic (over 6 months). Early treatment is the key to improve the prognosis, however, the majority of clinic trails nowadays are focusing on sub-acute or chronic phase because it takes 4-6 weeks to expand the autologous stem cells. In this study, the investigators will treat patients with acute spinal cord injury with autologous bone marrow-derived mononuclear cells and compare with the control group.
Detailed Description: None

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: