Can your own cells ease osteoarthritis pain?

NCT ID NCT05507099

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This trial tests whether a single injection of a patient's own fat-derived cells (lipoaspirate) or bone marrow cells can reduce pain and improve function in adults with knee or hip osteoarthritis. About 400 participants will be randomly assigned to one of the two treatments and followed for a year. The study compares how well each approach works for pain relief and joint stiffness.

What this could mean

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

Active substance
Autologous cell therapy: bone marrow aspirate or lipoaspirate concentrate
What this could lead to
If one of these cell therapies proves better, it could offer a more effective, minimally invasive option for easing osteoarthritis pain and improving joint function.
What could go wrong
This is a phase 2 trial, so results are preliminary. The therapies may not provide lasting relief, and there are risks like infection or pain at the injection site.

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

About 400 people

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

Started

Aug 2022

Expected to finish

Aug 2028

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

18 to 95 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: 1. Male or female, aged 18 to 95 years old 2. Residents of Canada 3. Written informed consent to participate in the study 4. Willingness and ability to comply with the study procedures and phone visit schedules and ability to follow verbal and written instruction 5. The NRS for at least 5 daily measures will be used to calculate the average score. An average NRS pain score 4-9 (moderate to severe pain). 6. Diagnosis of symptomatic knee or hip osteoarthritis for at least 12 weeks prior to screening based on an X-ray performed within 1 year prior to screening period. 7. Radiographic evidence of OA of the index knee or hip (Kellgren-Lawrence Grade I to IV) within 1 year prior to screening or during the screening period. 8. Failed conservative treatment for more than 12 weeks before the screening, meaning that pain persists for more than 12 weeks after the patient tried two or more of the following medication or interventions in that period. * oral analgesics, including over-the-counter medications and supplements, * physiotherapy * acupuncture * bracing * cortisone injections, * hyaluronic acid injections, * dextrose injections (prolotherapy) * platelet-rich plasma injections 9. Women of childbearing potential must use an effective method of contraception from 14 days prior to baseline visit to 360 days after intervention. Effective birth control considered for this trial are total abstinence; consistent use of birth control pills; injectable birth control methods; intrauterine device placement; and tubal ligation or male partner with vasectomy; diaphragm with contraceptive jelly or condom with contraceptive foam.This does not apply to male and postmenopausal women. 10. Body mass index (BMI) ≤ 50 kg/m2 Exclusion Criteria: 1. Women who are pregnant or planning to become pregnant during the trial period. 2. Women of childbearing potential (not surgically sterile or post-menopausal for at least one year) not using a highly effective method of contraception such as total abstinence; consistent use of birth control pills; injectable birth control methods; intrauterine device placement; and tubal ligation or male partner with vasectomy; diaphragm with contraceptive jelly or condom with contraceptive foam. 3. History of malignancy except for the diagnosis of basal cell carcinoma, within 5 years prior to pre-screening. 4. Presence of retained rods or screws or insertion or joint replacement in the joint to be injected 5. History of autoimmune diseases including lupus and rheumatoid arthritis 6. Prior arthroscopic or open surgery of the index joint within 6 months prior to screening 7. Planned arthroscopic or open surgery of the index joint during study period 8. Intra-articular injections in the index joint within 3 months prior to screening for corticosteroids or dextrose injections, and within 6 months prior to screening for hyaluronic acid or platelet-rich plasma (PRP) injections 9. Use of systemic immunosuppressives, immunomodulators or chemotherapeutic agents within 3 months prior to baseline visit 10. Know hypersensitivity to lidocaine, epinephrine or heparin 11. History of coagulopathy 12. Fever (forehead temperature above 38.0 centigrade) at baseline visit 13. Subjects with cutaneous infection at the lipoaspirate or bone marrow aspirate site and/or in the area of the injection at baseline visit 14. Subjects with hemoglobin less than 10 g/L 15. Subjects with platelet count less than 155x109/L 16. Subjects participating in a study of an experimental drug or medical device within 30 days of study entry 17. Any medical condition the qualified investigator believes makes the patient unsuitable for the study 18. Subjects using warfarin before the screening, with an INR above 3

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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 study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Karmy Clinic

    RECRUITING

    Brampton, Ontario, L6V 1B4, Canada

    Contact Email: •••••@•••••

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