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Knee pain showdown: bone marrow vs belly fat cells

NCT ID NCT06040957

Disease control Sponsor: Istituto Ortopedico Rizzoli Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a single injection of cells from your own bone marrow or belly fat can better ease knee osteoarthritis pain and stiffness. 204 adults aged 40-75 with knee OA will be randomly assigned to one of the two treatments. The goal is to see which cell source works best and whether either can slow the disease.

What this could mean

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

Active substance
Bone marrow aspirate concentrate or minimally manipulated adipose tissue (the patient's own cells)
What this could lead to
If it works, this could point toward a more effective, single-injection cell therapy to reduce pain and improve function in knee osteoarthritis.
What could go wrong
This is a mid-sized trial comparing two existing approaches, not a new breakthrough. Results may show no clear winner or only modest benefits, and individual responses vary.

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

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

About 204 people

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

Started

Jan 2024

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

40 to 75 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: Patients with symptomatic unilateral knee OA with: 1. Men or women aged 40 to 75 years; 2. Signs and symptoms of OA with a clinical history of gonalgia or swelling for at least 6 months; 3. Radiographic signs of OA (Kellgren-Lawrence grade 1-4); 4. No benefit after at least 4 months of conservative treatment; 5. Ability and consent of patients to actively participate in clinical and radiological (rx and MRI) follow-up; 6. Signing of informed consent. Exclusion Criteria: 1. Patients unable to express consent; 2. Patients aged \< to 40 and \> to 75 years; 3. Patients with axial deviations \> 5°; 4. Patients who have suffered trauma or undergone intra-articular infiltration of other substance in the previous 6 months; 5. Patients who have undergone knee surgery in the previous 12 months; 6. Patients with concomitant knee injuries causing joint pain or swelling (-focal full-thickness osteochondral defects, acute meniscal injuries); 7. Patients with malignant neoplasms; 8. Patients with uncompensated systemic diseases (rheumatic diseases, metabolic disorders such as diabetes and thyroid diseases); 9. Patients with infectious diseases; 10. Patients with histories of alcohol or drug abuse; 11. Patients who are pregnant; 12. Patients with allergies to anesthetics used in the procedure.

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Conditions

The condition(s) this trial relates to.

osteoarthritis, knee

As listed by the trial registrant

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

Knee osteoarthritis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. 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

  • Istituto Ortopedico Rizzoli

    RECRUITING

    Bologna, 40136, Italy

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