CI

At a glance

ClinicalIndex Comparison Record
Phase 1Active· 9 target
Drug / intervention
PremierMaxCB®-Platinum (CFL001);biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06415461
NCT06415461Phase 1ActiveOn TrackUpdated 5mo ago
CompareCT.gov

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

University of Florida·interventional·Posted May 16, 2024·Updated Jan 20, 2026

In Brief

A Phase 1 clinical trial evaluating PremierMaxCB®-Platinum (CFL001); for Sacroiliac; Backache and Pain, Back. Active but no longer recruiting, targeting 9 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSacroiliac; Backache, Pain, Back
CountriesUnited States
CollaboratorsCord for Life, Inc.

Timeline

Phase 1Active
2025202620272028
First PostedMay 16, 2024
Enrollment StartMay 10, 2024
Primary CompletionJan 15, 2027
Study CompletionMar 6, 2028
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 2.1 years agoPrimary completion in 6 months

Interventions

PremierMaxCB®-Platinum (CFL001);biological

Stem Cell: Human cell, tissue, and cellular or tissue-based product (HCT/P) manufactured from umbilical cord blood