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Lumbar Disc HerniationPhase 1NCT06022263

STA363 in the Treatment of Lumbar Disc Herniation

A Phase 1 study testing Lactic Acid in people with Lumbar Disc Herniation, run by Stayble Therapeutics at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Lumbar Disc Herniation
What is being tested?
Lactic Acid
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
1 sitePoland
Study dates
25 Jul 2023to 1 Sep 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Signed informed consent prior to any study-related procedures
  • Patient has a single subligamentous posteriolateral lumbar disc herniation (protrusion or extrusion) of any lumbar disc below L1/L2 diagnosed by clinical symptoms and/or physical findings and confirmed by MRI
  • Patient has symptoms and/or physical findings consistent with a unilateral radiculopathy affecting one nerve root (L2-L5)
  • Patient has leg pain of the dermatome consistent with the nerve root affected by the herniation
  • The herniated disc is 3 or lower on the Pfirrmann scale (grade 1-5)
  • Patient has experienced symptoms of a herniated disc for at least 6 weeks prior to randomisation without sufficient relief with pain medications and other conservative therapies
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  • Ability to understand the written and verbal information about the study
  • Male and female patients 18 years or older but 50 years or younger
  • Women of childbearing potential eligible if using effective contraceptives
  • Patient has a body mass index (BMI) of ≥18 to ≤35 kg/m2
  • Patients who meet all the following NRS selection criteria for radicular leg pain:
  • Presence of at least 5 pain NRS assessments (entries) for 7 consecutive days
  • NRS daily pain scores between 3-9
  • Not more than 2 NRS scores of "3"

Who cannot join

  • Treatment with any investigational product within 3 months prior to the screening visit
  • Patient has a sequestered lumbar disc herniation or transligamentous/ herniation confirmed by MRI
  • Patient has a bulging disc
  • Patient has experienced symptoms of lumbar disc herniation for more than 6 months
  • Patient has 2 or more symptomatic lumbar disc herniations (presence of non-symptomatic herniations in addition to the symptomatic herniation is allowed)
  • Patient has cauda equina syndrome
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  • Previous intradiscal therapeutic intervention of the index disc or has had any lumbar spine surgery
  • Presence of lumbar spine disease and/or clinically significant deformity other than a lumbar disc herniation which, in the opinion of the investigator, will affect evaluation of safety and/or efficacy
  • Untreated, ongoing active infection and/or discitis
  • Current infection or prior history of spinal infection (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection.
  • Evidence of prior lumbar vertebral body fracture or trauma.
  • Spondylolisthesis or retrolisthesis grade 2 and above or spondylolysis at the index or adjacent level(s).
  • Lumbar spondylitis or other undifferentiated spondyloarthropathy affecting the index disc.
  • Patients previously included in the study.
  • Patients suffering from psychosomatic pain in the opinion of the Investigator.
  • Patients requiring continuous treatment with warfarin or other anticoagulant therapy.
  • Known alcohol and/or drug abuse.
  • Pregnant or lactating females, or intention to become pregnant within the study period.
  • Known allergy or intolerance to the contrast agent Omnipaque®.
  • Known opioid allergy or intolerance.
  • Any other condition that, in the opinion of the Investigator, precludes the patient from taking part in this study.
  • Any specific contraindication for MRI such as claustrophobia, intracranial clips or pacemakers.

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Ortopedii i Rehabilitacji

    Lublin, Lublin Voivodeship, 20-002

Other trials in Poland

About this study

Official title: A Prospective, Randomised, Double-blinded, Placebo-controlled Study Investigating the Safety and Tolerability of STA363 in Patients With Radiculopathy Caused by Lumbar Disc Herniation

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.

Read the detailed description

The study will include 24 patients, recruited at 4 different sites, suffering from radiculopathy due to lumbar disc herniation (LDH). Patients will be screened for symptoms, disease history and magnetic resonance imaging (MRI) evidence of LDH. Baseline data (e.g. pain recording and MRI data) will be collected, and 1/3 of the patients will then be randomized to intradiscal injection with placebo (Omnipaque with water for injection, 1.5 mL) and 2/3 of the patients will be randomized to STA363 (lactic acid, 120 mg/mL with Omnipaque, 1.5 mL). The injections will be done using fluoroscopic guidance, and the patients will be treated with intravenous antibiotics and sedatives. The first follow-up will be done by phone 1 week after the treatment, while the other follow-ups will be physical visits at month 1, 3 and 6 at the site. In conjunction with the visits, the patient will record daily pain intensity (Numerical Rating Scale) for 7 days using an eDiary, and MRI will be performed. The primary completion time is 6 months with the primary objectives safety and tolerability. Important secondary objectives will be changes of disc volume and pain.

Being tested
Lactic Acid, Placebo
Keywords
Lumbar radiculopathy
Medical subject headings
Intervertebral Disc Displacement, Radiculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lactic AcidDrug

    Also called STA363

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

  • PlaceboDrug

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

Study groups in NCT06022263
Study groupRoleWhat they receive
PlaceboPlacebo comparator1.5 mL of Omnipaque mixed with water for injection
Receives: Drug: Placebo
STA363Experimental1.5 mL of STA363 (lactic acid, 120 mg/mL) mixed with Omnipaque
Receives: Drug: Lactic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability

    Safety and tolerability will be measured using the following outcomes:

    • Incidence and nature of adverse events (AEs)
    • Changes in
    • physical examination findings
    • blood pressure and heart rate
    • 12-lead electrocardiogram
    • Hematology and clinical chemistry
    • Pain intensity at the injection site during and 15 minutes after injection (numerical rating scale; NRS). NRS is reported on a 0-10 scale where 0 represents "No pain" and 10 "Worst imaginable pain"
    • Other aspects of intervertebral disc morphology (IVD) morphology from baseline (e.g., Modic changes)

    Measured: Baseline and 1 week and 1,3 and 6 months after intervention for all outcomes except changes in IVD morphology (time frame 1, 3 and 6 months after intervention)

Secondary outcomes (5)

  1. Disc volume

    Volume will be measured by MRI

    Measured: Baseline and 1,3 and 6 months after intervention

  2. Disc height

    Height will be measured by MRI

    Measured: Baseline and 1,3 and 6 months after intervention

  3. Radicular leg pain

    Leg pain will be reported by the patients using an NRS. (minimum value: 0; maximum value: 10) for 7 consecutive days. Lower scores means a better outcome.

    Measured: Baseline and 1 week and 1,3 and 6 months after intervention

  4. Patient Global Impression of Change (PGIC)

    PGIC will be reported by the patients using an electronic device

    Measured: Baseline and 1 week and 1,3 and 6 months after intervention

  5. Disc intensity

    The intensity of the disc will be measured using T2-weighted MRI

    Measured: Baseline and 1,3 and 6 months after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2023
  2. Study start25 Jul 2023
  3. Primary completion1 Sep 2024
  4. Study completion1 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06022263
Sponsor's protocol ID
STA-LDH01
Status last verified
Dec 2025
First submitted
21 Aug 2023
Last updated
10 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lactic Acid in people with Lumbar Disc Herniation, run by Stayble Therapeutics at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability (time frame: Baseline and 1 week and 1,3 and 6 months after intervention for all outcomes except changes in IVD morphology (time frame 1, 3 and 6 months after intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06022263.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.

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