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Your own cells could mend shattered bones in breakthrough trial

NCT ID NCT03024008

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a treatment called BonoFill-II for people with severe bone fractures that won't heal on their own. The treatment uses a patient's own cells to help grow new bone. The goal is to see if it is safe and can restore the bone and the ability to use the limb. About 40 adults with hard-to-heal fractures will take part.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 40 people

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

Started

Jul 2017

Expected to finish

Jun 2027

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 80 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: * Long and short bones extra articular comminuted fracture or * Long and short bones extra and intra articular defect/gap or non union, incapable of self-regeneration Exclusion Criteria: * Age is under 18 or above 80 * A simple fracture manageable by one definitive treatment * Pregnant or lactating women * Patients with active infection that is in question and needs osteogenic treatment. * More than 3 previous failed interventions at the surgical site * History of advanced congestive heart failure or active acute myocardial infarction (AMI), renal failure (estimated GFR of \<30 ml/min/1.73 m2 at screening), or hepatic disease (hepatic insufficiency classified as Child-Pugh B or C) * Diabetic subjects (HbA1c \> 8) * Subject treated currently with systemic steroids. * Subjects with known autoimmune diseases, such as Addison's disease, Celiac disease - sprue (gluten-sensitive enteropathy), Dermatomyositis, Graves disease, Hashimoto's thyroiditis, Multiple sclerosis, Myasthenia gravis, Pernicious anemia, Reactive arthritis, Rheumatoid arthritis, Sjogren syndrome, Systemic lupus erythematosus. * Subjects diagnosed with osteoporosis * Chronic severe PVD (Peripheral Vascular Disease) subjects * Post major vascular operation in the treated limb/s and above the surgical site (with or without Gore-Tex grafting) * Subjects that have a known scar healing problem (keloid formation). * Subjects treated with Bisphosphonate drugs * Oncology patient or subjects who received chemotherapy or radiotherapy treatment in the past 12 months * Immunocompromised condition from any reason, at screening * Subjects participating in another clinical trial 30 days prior to and during the study period. * Drug addicts and psychiatric patients patients incapable of giving consent. * Subjects with a known history of any significant medical disorder, which in the investigator's judgment contraindicates the subject's participation * Subjects with any known allergy for local/general anesthesia * Positive serology for either HIV, hepatitis B or hepatitis C * Abnormal clinically significant laboratory test and findings, as per the investigator's judgment

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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.

  1. The places running it

    6 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

  • Barzilai Medical Center

    RECRUITING

    Ashkelon, 7830604, Israel

  • Carmel Medical Center

    RECRUITING

    Haifa, Israel

  • Emek Medical Center

    RECRUITING

    Afula, 1834111, Israel

  • Hillel Yafe

    RECRUITING

    Hadera, Israel

  • Meir Medical Center

    RECRUITING

    Kfar Saba, Israel

  • Rambam Health Campus

    RECRUITING

    Haifa, Israel

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