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STA363 in the Treatment of Lumbar Disc Herniation

NCT06022263 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-12-10

No results posted yet for this study

Summary

The goal of this clinical trial is to establish safety and tolerability of STA363 injected into a herniated intervertebral disc in patients with sciatica due to disc herniation. The main questions the trial aims to answer are:

1. Is the treatment safe and tolerable?
2. Does the volume of the disc and the herniation decrease?
3. Is sciatica reduced? Participants will be given an injection into the herniated disc of either placebo or STA363 (one dose).

Researchers will compare safety, tolerability, effects on disc and herniation volume and on symptoms between the group of patients injected with placebo and the group injected with STA363.

Conditions

  • Lumbar Disc Herniation

Interventions

DRUG

Lactic Acid

180 mg of STA363 will be slowly injected into a symptom-generating herniated lumbar disc

DRUG

Placebo

1.5 mL of Omnipaque in water for injection will be slowly injected into a symptom-generating herniated lumbar disc

Sponsors & Collaborators

  • Cromsource

    collaborator INDUSTRY

  • Antaros Medical

    collaborator INDUSTRY

  • VIEDOC

    collaborator UNKNOWN

  • Stayble Therapeutics

    lead INDUSTRY

Principal Investigators

  • Jarkko Kalliomäki, MD, PhD · Stayble Therapeutics AB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-07-25
Primary Completion
2024-09-01
Completion
2024-09-01

Countries

  • Poland

Study Locations

More Related Trials

Entities

Drugs

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 NCT06022263 on ClinicalTrials.gov