Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06415461
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-05-26
Brief Title:
A Study Assessing the Safety of Cord Blood Product in Sacroiliac Joint Syndrome SIJ
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
A Phase 1 Open Label Dose-Ranging Study to Assess the Safety Tolerability Preliminary Efficacy and Dose Effect of CFL001 Cord Blood Product in Patients With Symptomatic Sacroiliac Joint Syndrome
Status:
RECRUITING
Status Verified Date:
2024-07
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:
SIJ
Brief Summary:
This is a Phase 1 trial The overall objective is to evaluate the safety and potential efficacy effect of specific type of umbilical cord blood product CFL001 which other than specific modifications in manufacturing to render it compatible with current Good Manufacuring Practice cGMP is essentially similar to that reported in real-world experience
Detailed Description:
The Phase 1 trial will enroll three subjects into an initial group receiving a low dose of CFL001 Provided that these subjects tolerate this dose well will proceed to enroll three subjects into a group receiving a middle dose of CFL001 Provided that these subjects tolerate this dose well will proceed to enroll three subjects into a group receiving the highest dose of CFL001
All subjects will have Symptomatic Sacroiliac Joint SIJ syndrome with clinical average pain score in the month prior to enrollment 50 and 90 on a 100-point scale
All subjects will have Symptomatic Sacroiliac Joint SIJ syndrome with clinical average pain score in the month prior to enrollment 50 and 90 on a 100-point scale
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None