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TTAX03 for the Treatment of Lumbosacral Facet Joint Pain

NCT06236308 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2025-03-07

No results posted yet for this study

Summary

This is a pilot study examining the safety and efficacy of a single intra-articular (IA) injection of TTAX03 per joint to relieve severe spinal facet joint (FJ) pain and improve function in subjects with facet joint pain (FJP) in the lumbosacral region. The design is randomized, double blinded, placebo controlled and dose-group sequential.

Conditions

  • Facet Joint Pain

Interventions

BIOLOGICAL

TTAX03 10mg

TTAX03 is a sterile, lyophilized and micronized particulate human AM and UC product manufactured using aseptic techniques followed by terminal sterilization by gamma-irradiation in compliance with Current Good Tissue Practices (CGTP) and Current Good Manufacturing Practices (CGMP) to preserve extracellular matrices and growth factors/cytokines therein without any living cells.

BIOLOGICAL

TTAX03 25mg

TTAX03 is a sterile, lyophilized and micronized particulate human AM and UC product manufactured using aseptic techniques followed by terminal sterilization by gamma-irradiation in compliance with Current Good Tissue Practices (CGTP) and Current Good Manufacturing Practices (CGMP) to preserve extracellular matrices and growth factors/cytokines therein without any living cells.

BIOLOGICAL

Placebo Comparator: Control Saline

2 mL Sterile, preservative free 0.9% NaCl

Sponsors & Collaborators

  • BioTissue Holdings, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-15
Primary Completion
2025-01-31
Completion
2025-03-04
FDA Drug
Yes

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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 NCT06236308 on ClinicalTrials.gov