Can your own cells ease osteoarthritis pain?
NCT ID NCT05507099
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
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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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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2022
- Expected to finish
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Aug 2028
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 95 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: 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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. 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
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Locations
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Karmy Clinic
RECRUITINGBrampton, Ontario, L6V 1B4, Canada
Contact Email: •••••@•••••
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