NCT06415461

A Study Assessing the Safety of Cord Blood Product in Sacroiliac Joint Syndrome (SIJ)

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: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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 Manufacturing 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.

Conditions

• Sacroiliac; Backache
• Pain, Back

Interventions

Type	Name	Description
BIOLOGICAL	PremierMaxCB®-Platinum (CFL001);	Stem Cell: Human cell, tissue, and cellular or tissue-based product (HCT/P) manufactured from umbilical cord blood

Timeline

• Start date: 2024-05-10
• Primary completion: 2027-01-15
• Completion: 2028-03-06
• First posted: 2024-05-16
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study