Could your own bone marrow cells save your hip from collapse?
NCT ID NCT06123481
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times
Summary
This study tests whether adding a patient's own concentrated bone marrow cells to a standard hip surgery (core decompression) can prevent the hip ball from collapsing and delay or avoid the need for a hip replacement. It includes 192 adults with early-stage osteonecrosis (before collapse) and compares the combination treatment to surgery alone over two years. The goal is to preserve the natural hip joint and reduce pain.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 192 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 90 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria * Participants who have non-traumatic osteonecrosis of the femoral head * Only participants who have Stage 1 or 2 osteonecrosis as assessed by the 2019 ARCO Staging System * No evidence of subchondral fracture * All osteonecrotic lesion sizes * All major risk factors (e.g. corticosteroids, alcohol, organ recipient) except for those listed in the exclusion criteria * Participants diagnosed who have femoral head osteonecrosis for which no risk factor has yet to be identified * Participants will include all ethnicities and races * Be able and willing to participate in study and return for postoperative visits Exclusion Criteria * Participants who have: * Sickle Cell disease * Major trauma * Post-irradiation ON * Gaucher Disease * Juvenile form: Legg-Calve-Perthes Disease * Juvenile form: Spontaneous ON of the hip * Pregnant or breastfeeding * Vulnerable population; i.e., prisoners and institutionalized individuals * Participant is unable to undergo an MRI * Participants who have evidence of a subchondral fracture * Prior history of hip surgery, more extensive than hip arthroscopy
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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.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Cleveland Clinic
RECRUITINGCleveland, Ohio, 441195, United States
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Johns Hopkins University
RECRUITINGBaltimore, Maryland, 21224, United States
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55905, United States
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NYU Langone Health Orthopedic Hospital
RECRUITINGNew York, New York, 11016, United States
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Sinai Hospital of Baltimore
RECRUITINGBaltimore, Maryland, 21215, United States
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Stanford University
RECRUITINGStanford, California, 94063, United States
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University of Minnesota
RECRUITINGMinneapolis, Minnesota, 55455, United States
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University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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University of Southern California
RECRUITINGLos Angeles, California, 90033, United States
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University of Virginia
RECRUITINGCharlottesville, Virginia, 22903, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Ceramic hip resurfacing: a Metal-Free future for joint replacement?
- Can a new hip implant stand the test of time?
- Stem cells and oxygen therapy may save hips from collapse
- Hip replacement device study pulled before it started
- Blood test could catch hip disease before It's too late
- New drug RAB001 takes first step: safety check in healthy volunteers