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NCT06415461 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Pain, Back and Sacroiliac; Backache, sponsored by University of Florida.

Active
Registry status
Phase 1
Development phase
9
Enrollment target
1
Study location

NCT06415461: Active Phase 1 study of Pain, Back and Sacroiliac; Backache, sponsored by University of Florida.

NCT06415461 is a Phase 1 study of Pain, Back and Sacroiliac; Backache that is active but no longer recruiting, run by University of Florida. The registered enrollment target is 9 participants, below the 331-participant average among 7 other Pain, Back trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06415461, a Phase 1 study of Pain, Back and Sacroiliac; Backache, is active but no longer recruiting, sponsored by University of Florida.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
9 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

All Adverse events (types and frequencies) will be collected for all patients. Protocol defined study endpoints will also be collected on all patients. Study endpoints include: • Stopping criteria as defined in protocol

Interventions

  • BIOLOGICAL PremierMaxCB®-Platinum (CFL001);

Study Locations (1)

Florida

  • University of Florida Pain Clinic - Gainesville

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2024-05-10
Est. Completion 2028-03-06
Phase Phase 1
University of Florida

1,106 total trials

What the registry record for NCT06415461 still lists

NCT06415461 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 331-participant average among 7 other Pain, Back trials with a reported enrollment target (97% lower).

The record links to 2 conditions, with Pain, Back appearing as the primary indexed condition, and to 1 intervention - of which PremierMaxCB®-Platinum (CFL001); is the first listed.

NCT06415461 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT06415461 about?

NCT06415461 is a clinical study titled "A Study Assessing the Safety of Cord Blood Product in Sacroiliac Joint Syndrome (SIJ)". 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 esse...

What is the current status of trial NCT06415461?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2024-05-10. Estimated completion is 2028-03-06.

What conditions does trial NCT06415461 study?

This clinical trial studies the following conditions: Pain, Back, Sacroiliac; Backache.

What interventions are being tested in trial NCT06415461?

The interventions under investigation include: PremierMaxCB®-Platinum (CFL001); (BIOLOGICAL).

Who is sponsoring clinical trial NCT06415461?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06415461 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Pain, Back

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Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

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Source: ClinicalTrials.gov NCT06415461, the US trial registry maintained by the National Library of Medicine. NCT06415461 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.