Stem cell patch mends broken bones that Won't heal
NCT ID NCT01842477
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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30 people
The number who actually took part.
- Start date
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May 2013
- Finished
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Feb 2016
- Lead sponsor
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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
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18 to 65 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: * 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
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Department of Orthopaedic Surgery, CHRU Tours
Tours, 37044, France
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Department of Orthopaedic Trauma, University of Ulm
Ulm, 89081, Germany
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Depatment of Orthopaedic Surgery, Hôpital Henri Mondor
Créteil, 94000, France
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Istituto Ortopedico Rizzoli, Bologna
Bologna, 40136, Italy
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Servicio de Cirugía Ortopédica y Traumatología "A", Hospital La Paz
Madrid, 28046, Spain