Spinal fluid antibody shots tested for fresh spinal cord injuries
NCT ID NCT06817577
First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
Researchers are testing an experimental human monoclonal antibody called NG004 in people who have recently sustained an acute incomplete cervical spinal cord injury. Participants receive repeated injections of NG004 directly into the spinal fluid. The trial's main goal is to check safety, tolerability, and how the body processes the antibody across four dose levels, and to find the highest dose people can take without unacceptable side effects. About 20 adults injured 4 to 28 days earlier take part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental human monoclonal antibody called NG004, given as repeated injections into the spinal fluid
- What this could lead to
- If NG004 proves safe and tolerable, researchers could move it into larger trials to see whether it helps preserve or restore movement and feeling after a spinal cord injury.
- What could go wrong
- This is a first-in-human Phase 1 trial with about 20 participants, so its main job is checking safety, not proving benefit. The antibody may cause side effects, fail to reach the injury site effectively, or show no meaningful recovery signal, and results in this small, specific group may not apply to other spinal cord injuries.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Acute incomplete cervical SCI (Neurological level of injury C1 ≤ lesion ≤ C8) with confirmed classification of American Spinal Injury Association (ASIA) impairment scale (AIS) C-D at Screening * 4-28 days post-injury * No required mechanical ventilation or patients that not completely depend on mechanical ventilation * Hemodynamically and clinical stable patient according to the acute SCI condition at baseline Exclusion Criteria: * Trauma caused by ballistic or other injury that directly penetrates the spinal cord including gunshot and knife wounds * Multiple levels of clinically relevant spinal cord lesions * Major brachial or lumbar plexus damage/trauma * Significant head trauma or other injury that was, in the opinion of the investigator, sufficient to interfere with the assessment of the spinal cord function * Other significant pre-existing or current severe systemic disease such as lung, liver (exception: history of uncomplicated Hepatitis A), gastrointestinal, cardiac, immunodeficiency (including anamnestic known HIV) or kidney disease; or active malignancy * History of or an acute episode of Multiple Sclerosis or Guillain-Barre syndrome History of recent (6 months) meningitis or meningoencephalitis * History of refractory epilepsy * History of or current autoimmune disease * Patients with uncontrolled bleeding diathesis and/or who require concomitant therapeutic anticoagulation and not related to SCI * Presence of any unstable medical or psychiatric condition * Drug dependence any time during the 6 month's preceding trial entry * Pregnant or nursing women * History of a life-threatening allergic or immune mediated reaction * Patients with the presence of infection around the location where the spinal needle insertions are planned for applying the intrathecal injections * Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations * Patients who are unconscious
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Klinik für Paraplegiologie, Universitätsklinikum Heidelberg
RECRUITINGHeidelberg, Germany
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Klinik für Querschnittgelähmte, Klinikum Bayreuth
RECRUITINGBayreuth, Germany
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Swiss Paraplegic Centre
RECRUITINGNottwil, Switzerland
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Universitätsklinik Balgrist
RECRUITINGZurich, Switzerland
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Zentrum für Rückenmarksverletzte, Unfallklinik Murnau
RECRUITINGMurnau am Staffelsee, Germany
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Zentrum für Rückenmarkverletzte und Klinik für Orthopädie, BG Klinikum Bergmannstrost
RECRUITINGHalle, Germany
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