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Can a spinal injection restore movement after paralysis?

NCT ID NCT07722962

Cure Sponsor: Kringle Pharma, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether an experimental drug called KP-100IT, injected into the spinal fluid, can help people with severe acute spinal cord injuries regain function. Participants, aged 18 to 89 with a complete loss of motor and sensory function (AIS grade A), receive five weekly doses and are followed for 24 weeks. The study measures improvements in spinal injury classification, motor and sensory scores, and the ability to perform daily activities.

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 drug called KP-100IT injected into the spinal fluid
What this could lead to
If it works, this could point toward a treatment that helps people with severe spinal cord injuries recover significant movement and sensation.
What could go wrong
This is a small, early-phase trial with only 10 participants, so results may not apply widely. The drug is injected directly into the spine, which carries risks like infection or nerve damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 89 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients whose AIS grade is A at 72 hours (± 6 hours) after injury * age: 18 years to 89 years * MRI imaging and other tests confirm the continuity of the spinal cord Exclusion Criteria: * The injury site is C1-C2 or C2-C3 * The patient with a spinal crd compression rate of 70% or higher. * The patient in whom a spinal cord rupture is strongle suspected. * The patient cannot start rehabilitation necessary for recovery of function at an early stage. * External trauma or concurrent organ injury. * High dose steroid therapy administered for the treatment of spinal cord injury * History or concurrent presence of malignant tumor. * It is inappropriate for the subject to be included in the study, in the opinion of the investigator.

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Conditions

The condition(s) this trial relates to.

autosomal recessive nonsyndromic hearing loss 39 spinal cord injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute spinal cord injury (SCI)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Japan Organization for Occupational Health and Safety Comprehensive Spinal Cord Injuries Center

    Iizuka, Fukuoka, 820-8508, Japan

  • Japan Organization for Occupational Health and Safety Hokkaido Spinal Cord Injury Center

    Bibai, Hokkaido, 072-0015, Japan

  • National Hospital Organization Murayama Medical Center

    Musashimurayama, Tokyo, 208-0011, Japan

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