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

NCT06415461 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-01-20

No results posted yet for this 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.

Conditions

  • Sacroiliac; Backache
  • Pain, Back

Interventions

BIOLOGICAL

PremierMaxCB®-Platinum (CFL001);

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

Sponsors & Collaborators

  • Cord for Life, Inc.

    collaborator UNKNOWN

  • University of Florida

    lead OTHER

Principal Investigators

  • Rene Przkora, MD, PHD · University of Florida

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-10
Primary Completion
2027-01-15
Completion
2028-03-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06415461 on ClinicalTrials.gov