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Open Label Dose Ranging Study Assessing the Safety of Cord Blood Product in Sacroiliac Joint Syndrome (SIJ) — SIJ  

Pain, Back Clinical Trial

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

Clinical Trial 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 cGMP, is essentially similar to that reported in real-world experience.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06415461
Study type Interventional
Source University of Florida
Contact Dana D Leach, DNP
Phone 352-273-8933
Email leach@ufl.edu
Status Recruiting
Phase Phase 1
Start date May 10, 2024
Completion date December 30, 2025
View Details
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