Ignite Creation Date:
2024-05-06 @ 8:11 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02687672
Status:
UNKNOWN
Last Update Posted:
2020-03-17
First Post:
2016-02-16
Brief Title:
Transplantation of Autologous Bone Marrow or Leukapheresis-Derived Stem Cells for Treatment of Spinal Cord Injury
Sponsor:
Stem Cells Arabia
Organization:
Stem Cells Arabia
Study Overview
Official Title:
Transplantation of Purified Autologous Bone Marrow- or Leukapheresis-Derived CD34 and CD133 for Patients With Spinal Cord Injuries A Long-Term Comparative Evaluation of Safety and Efficacy Study
Status:
UNKNOWN
Status Verified Date:
2020-03
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:
This is a double-armed Phase III trial aims to compare bone marrow and leukapheresis as sources for purified autologous CD34 and CD133 stem cells SCs to be utilized in treatment of patients with chronic complete spinal cord injuries SCI The study focuses on the safety and efficacy of transplanting un-manipulated autologous purified stem cells into the injured spinal cords of patients
Detailed Description:
Spinal cord injury SCI leads to apoptosis of oligodendrocytes at the injury site resulting in demyelination and neuronal degeneration This degeneration causes severe functional sensory and motor mutilations that remain an immense challenge to physicians and in which stem cell SC transplantation represents a viable alternative This study is a phase III trial aimed at describing a method for treating patients with chronic complete spinal cord injuries SCI by utilizing autologous purified CD34 and CD133 stem cells SCs The study focuses on the safety and efficacy of transplanting un-manipulated autologous purified stem cells in treated patients during a 5-year follow-up period
Study Oversight
Has Oversight DMC:
None
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?:
None