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Sugar-Based gel shows promise for stroke patients in early trial

NCT ID NCT06700824

Disease control Sponsor: Organ, Tissue, Regeneration, Repair and Replacement 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested a new gel called OTR4132 in 60 people who had a stroke and received a clot-removal procedure. The gel is designed to help repair damaged brain tissue. Researchers measured neurological function at 24 hours and disability at 3 months to see if the gel improves recovery compared to a placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
OTR4132 (a sugar-based gel that helps repair damaged tissue)
What this could lead to
If it works, this could point toward a new treatment to help people recover better after a stroke.
What could go wrong
This is a small, early-phase trial with only 60 people, so results may not apply to everyone. The treatment is still experimental and may not show clear benefit.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

60 people

The number who actually took part.

Started

Mar 2025

Finished

Mar 2026

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 85 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: 1. Age between 18 and 85 years 2. Acute ischemic stroke in anterior circulation territory, identified by magnetic resonance imaging (MRI). 3. Occlusion of anterior circulation i.e. carotid artery (ICA) or proximal middle cerebral artery (MCA) (M1 and/or M2 segment) 4. Endovascular thrombectomy (with or without previous intravenous thrombolysis) 5. Recanalization confirmed by angiography after endovascular treatment: TICI grade 2b - 3 6. NIHSS (National Institute of Health Stroke Scale/Score) ≥ 11 7. Pre-stroke modified Rankin Score (mRS): 0 or 1 8. Patient\* or legally authorized representative (family member or trusted person if patient unable to give consent) or independent physician (if patient unable to give consent and if an authorized representative cannot be reached) has signed informed consent. * Patients unable to give consent at baseline will go through a deferred consent procedure to continue the study Exclusion Criteria: 1. Previous symptomatic stroke with permanent sequelae 2. Pre-existing medical, neurological, or psychiatric disease that would confound the neurological evaluation 3. Contraindication to MRI 4. Stroke lesion not visible on MRI 5. History of allergy or anaphylactic reactions to any of the ingredients of OTR4132-MD or heparinoids 6. History of hypersensitivity or anaphylactic reactions to iodinated contrast media 7. Intracranial tumor at inclusion 8. Pregnant or breastfeeding women 9. Severe renal failure with glomerular filtration rate (GFR) \< 30 mL/min 10. Severe uncontrolled arterial hypertension e.g. systolic blood pressure \> 185 mmHg or diastolic blood pressure \> 110 mmHg, or intravenous medication necessary to reduce blood pressure 11. Life expectancy of less than 3 months or co-morbidities that could influence the study results or would complicate assessment of outcomes (e.g. dementia, psychiatric disease) or would make clinical follow-up difficult 12. Increased risk of hemorrhage (for instance medical history of significant bleeding disorders, major surgery or significant trauma in the past 3 months, any history of suspected intracranial hemorrhage, symptoms suggestive of subarachnoid hemorrhage, even if the MRI is normal, international normalized ratio (INR)\>1.3 or activated partial thromboplastin time (aPTT)\>ULN (upper limit of normal) 13. Suspected cerebral vasculitis based on medical history and imaging 14. Occlusions in multiple vascular territories 15. Evidence of any prior intracranial intervention (i.e. neurosurgery, endovascular intervention) 16. Worsening of medical or neurological conditions or per-procedures complications 17. Any other serious, advanced, or terminal illness (investigator judgment) 18. Current participation in another therapeutic investigation (drug or device) 19. The patient is not a member or beneficiary of the French social security system

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Conditions

The condition(s) this trial relates to.

cerebral infarction ischemic stroke stroke disorder

As listed by the trial registrant

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

Endovascular thrombectomy Ischemic cerebrovascular accident

Contacts and locations

Locations

  • CHU Henri-Mondor

    Créteil, 94000, France

  • Centre Hospitalier Régional Universitaire de Lille- Hôpital Roger Salengro

    Lille, 59000, France

  • Centre Hospitalier Régional Universitaire de Nancy

    Nancy, 54000, France

  • Centre Hospitalier Universi-taire de Bordeaux-Hôpital Pellegrin

    Bordeaux, 33076, France

  • Centre Hospitalier Universitaire Grenoble Alpes

    Grenoble, 38043, France

  • Centre Hospitalier Universitaire de Martinique

    Fort de France, 97261, France

  • Centre Hospitalier Universitaire de la Guadeloupe

    Pointe à Pitre, 97159, France

  • Centre hospitalier universi-taire de Brest (Cavale Blanche)

    Brest, 29609, France

  • GHU Paris Psychiatrie & Neurosciences

    Paris, France, France

  • Hôpital Foch

    Suresnes, 92150, France

  • Hôpital Fondation Adolphe de Rothschild Service de neuro-vasculaire

    Paris, 75019, France

  • Hôpital de Hautepierre

    Strasbourg, 67200, France

  • Hôpital de la Pitié Salpêtrière - AP-HP

    Paris, 75013, France

  • Hôpitaux Universitaires De Marseille Timone-AP-HM

    Marseille, 13385, France

  • UIC Imagerie et Neurovasculaire CHU de Nantes

    Nantes, 44093, France

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