Phase 3 Osteoarthritis Trial, Recruiting

Written by an AI model from 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 who are willing and able to give written consent and follow all the steps required by the study.
• People who are 18 years of age or older at the time of signing the consent form.
• People who have been diagnosed with knee osteoarthritis according to American College of Rheumatology criteria, confirmed by X-ray or imaging taken within the last three months.
• People whose knee osteoarthritis has been graded as Grade I to IV on the Kellgren-Lawrence scale (a standard X-ray grading system for joint damage).
• People who have knee pain during activity rated at 40 or above on a pain scale of 0–100 at the time of their screening appointment.
• People whose body weight falls within a healthy to moderate range, specifically a Body Mass Index (BMI) between 18.5 and 35.0 (confirm with trial site if unsure how this is calculated).

Who may not be able to join:

• People who are unwilling or unable to complete the assessments required by the study.
• People whose knee is structurally unstable due to a complete tear of one or more major ligaments in the knee (such as the ACL, PCL, MCL, or posterolateral corner).
• People whose knee has an inward or outward angular misalignment of more than 5 degrees, as measured by a specific standing X-ray.
• People who had a partial surgical removal of the knee cartilage pads (meniscectomy) less than 9 months ago.
• People with a history of a serious joint infection (septic arthritis) in the knee being studied.
• People with a history of, or suspected, joint disease caused by infection or inflammation (such as rheumatoid arthritis or similar conditions).
• People who have had a corticosteroid (steroid) injection into any joint, or taken systemic steroids, within the 3 months before screening.
• People whose immune system is suppressed due to illness or medication — including but not limited to high-dose steroids, certain immune-modifying drugs, or biological therapies (confirm with trial site for specific medications).
• People who have planned surgery on either leg within the next 12 months.
• People with a current or suspected active infection of any kind.
• People who have had a cancer diagnosis in the past 2.5 years, except for certain early-stage cancers that were fully removed with the intent to cure.
• People with a severe bleeding disorder.
• People who have taken part in another clinical trial or received a different experimental treatment within the 30 days before joining this study.
• People who are currently pregnant or breastfeeding.
• People who are unwilling, or are medically advised not, to pause blood-thinning (anticoagulant) medications before the procedure, as determined by their prescribing doctor.
• People with a known diagnosis of HIV-1, HIV-2, Hepatitis A, Hepatitis B, Hepatitis C, HTLV-I/II, Syphilis, or any other active or ongoing infectious disease.
• People who have had a blood clot in the lungs (pulmonary embolism), a deep vein blood clot, or another serious clotting condition within the past 4 months.
• People with known allergies or sensitivities to DMSO, human serum albumin, heparin, or PlasmaLyte (substances that may be used in the study treatment).
• People with any medical condition, past or present, that might affect the study results or prevent full participation for the entire duration of the study (confirm with trial site).
• People who face cognitive or language barriers that prevent them from giving informed consent or completing study questionnaires.
• People who have received any stem cell therapy within the previous 12 months.

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