Phase 2 Osteoarthritis Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 95 years old, of any gender
• People who currently live in Canada
• People who are willing and able to give written consent to take part in the study
• People who are able and willing to follow the study procedures and attend scheduled phone check-ins
• People who have reported moderate to severe pain on average (a pain score of 4 to 9 out of 10 across at least 5 daily recordings)
• People who have been diagnosed with painful knee or hip osteoarthritis for at least 12 weeks before the screening visit, confirmed by an X-ray taken within the past year
• People whose X-ray shows osteoarthritis in the knee or hip being studied, graded on a standard scale (Kellgren-Lawrence Grade I to IV), within the past year or during the screening period
• People whose pain has continued despite trying two or more treatments for more than 12 weeks — these treatments may include pain-relief medications (including over-the-counter options and supplements), physiotherapy, acupuncture, bracing, cortisone injections, hyaluronic acid injections, dextrose injections (prolotherapy), or platelet-rich plasma injections
• Women who could become pregnant must use an effective form of contraception from 14 days before the first study visit until 360 days after the treatment — accepted methods include abstinence, birth control pills, injectable contraceptives, an intrauterine device (IUD), tubal ligation, a partner who has had a vasectomy, a diaphragm with contraceptive jelly, or a condom with contraceptive foam (this requirement does not apply to men or women who have gone through menopause)
• People with a body mass index (BMI) of 50 or below

Who may not be able to join:

• Women who are pregnant or planning to become pregnant during the study period
• Women who could become pregnant and are not using an effective form of contraception as listed above
• People who have been diagnosed with cancer in the past 5 years, except for a type of skin cancer called basal cell carcinoma
• People who have metal rods, screws, or a joint replacement already in the joint that would be treated
• People with a history of autoimmune conditions such as lupus or rheumatoid arthritis
• People who have had surgery (arthroscopic or open) on the joint being studied within the past 6 months
• People who have surgery planned on the joint being studied during the trial period
• People who have had certain injections into the joint being studied recently — specifically, corticosteroid or dextrose injections within the past 3 months, or hyaluronic acid or platelet-rich plasma (PRP) injections within the past 6 months
• People who have taken medications that suppress or modify the immune system, or chemotherapy drugs, within the past 3 months
• People with a known allergy or sensitivity to lidocaine, epinephrine, or heparin
• People with a history of blood clotting disorders
• People with a fever (forehead temperature above 38.0°C) at the baseline visit
• People with a skin infection at the site where fat or bone marrow would be collected, or at the injection site, at the baseline visit
• People with a haemoglobin level below 10 g/L (a measure of red blood cells in the blood) (confirm with trial site)
• People with a platelet count below 155×10⁹/L (platelets are cells that help blood clot) (confirm with trial site)
• People who are currently taking part in another study involving an experimental drug or medical device within the past 30 days
• People whose overall health condition leads the supervising investigator to consider them unsuitable for the study
• People taking the blood-thinning medication warfarin whose INR (a measure of how long blood takes to clot) is above 3

Important: Always verify eligibility with the trial site directly before applying.