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Stem cell patch mends broken bones that Won't heal

NCT ID NCT01842477

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a new way to help broken bones that are taking too long to heal. Doctors took a small sample of the patient's own bone marrow, grew the stem cells in a lab, and then placed them with a special bone-like material at the fracture site. The goal was to see if this approach is safe and can help the bone heal without needing a second surgery to take bone from another part of the body. The study involved 30 adults with leg or arm fractures that had not healed after at least 3 months.

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

30 people

The number who actually took part.

Start date

May 2013

Finished

Feb 2016

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 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: * Age 18 to 65, both sexes * Traumatic isolated closed or open Gustilo I and II humerus, tibial or femur diaphyseal or metaphyseal-diaphyseal fracture status delayed union or non-union * At least 3 months from acute fracture * Able to provide informed consent, and signed informed consent * Patients (by themselves) should have medical health care coverage to be included in a research study * Able to understand and accept the study constraints Exclusion Criteria: * Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control * Participation in another therapeutic trial in the previous 3 months * Delayed union or non-union related to iatrogeny * Segmental bone loss requiring specific therapy (bone transport, large structural allograft, megaprosthesis, etc) * Vascular or neural injury * Other fractures causing interference with weight bearing * Acute persistent chronic bacterial infections such as brucellosis, typhus, leprosy, relapsing fever, melioidosis and tularemia * Visceral injuries of diseases interfering with callus formation (cranioencephalic trauma, etc.) * History of bone harvesting on iliac crest contraindicating bone-marrow aspiration * Corticoid or immunosuppressive therapy more than one week in the three months prior to study inclusion * History of prior or concurrent diagnosis of HIV-, Syphilis, Hepatitis-B- or Hepatitis-C-infection (confirmed by serology or PCR) * History of neoplasia or current neoplasia in any organ * Subject legally protected, under legal guardianship, deprived of their liberty by judicial or administrative decision, subject of psychiatric care, or admission to a health facility. * Impossibility to meet at the appointments for the follow up * Insulin dependent diabetes * Obesity (BMI \> 30) * Autoimmune inflammatory disease * Current treatment by biphosphonate or stopped in the three months prior to study inclusion.

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Department of Orthopaedic Surgery, CHRU Tours

    Tours, 37044, France

  • Department of Orthopaedic Trauma, University of Ulm

    Ulm, 89081, Germany

  • Depatment of Orthopaedic Surgery, Hôpital Henri Mondor

    Créteil, 94000, France

  • Istituto Ortopedico Rizzoli, Bologna

    Bologna, 40136, Italy

  • Servicio de Cirugía Ortopédica y Traumatología "A", Hospital La Paz

    Madrid, 28046, Spain