Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073853
Status:
SUSPENDED
Last Update Posted:
2009-08-28
First Post:
2003-12-10
Brief Title:
Autologous Incubated Macrophages for Patients With Complete Spinal Cord Injuries
Sponsor:
Proneuron Biotechnologies
Organization:
Proneuron Biotechnologies
Study Overview
Official Title:
A Phase II Multicenter Randomized-Controlled Study to Evaluate the Safety and Efficacy of Autologous Incubated Macrophages for the Treatment of Patients With Complete Spinal Cord Injuries
Status:
SUSPENDED
Status Verified Date:
2006-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Autologous Incubated Macrophages ProCord is being developed as a therapy for acute complete spinal cord injury SCI The therapy is intended to reverse the loss of motor and sensory function
Following non-CNS tissue injury macrophages quickly arrive on the scene where they clean up cell debris secrete different molecules thus promoting a controlled inflammatory reaction that forms the first phase of the wound healing process While this process occurs in most tissues including peripheral nerves it does not occur in the CNS where macrophages and other immune cells are relatively rare and their activities curtailed by a biochemical mechanism known as immune privilege
In animal studies it appears that incubated macrophages circumvent the immune privilege thus supporting the regrowth of axons through the injury site and enabling the recovery of neurological function The concept derives from the pioneering research of Prof Michal Schwartz at the Weizmann Institute of Science
Following non-CNS tissue injury macrophages quickly arrive on the scene where they clean up cell debris secrete different molecules thus promoting a controlled inflammatory reaction that forms the first phase of the wound healing process While this process occurs in most tissues including peripheral nerves it does not occur in the CNS where macrophages and other immune cells are relatively rare and their activities curtailed by a biochemical mechanism known as immune privilege
In animal studies it appears that incubated macrophages circumvent the immune privilege thus supporting the regrowth of axons through the injury site and enabling the recovery of neurological function The concept derives from the pioneering research of Prof Michal Schwartz at the Weizmann Institute of Science
Detailed Description:
None
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