Autologous BMA Vs Saline and LAM + LP-PRP Vs Saline Evaluations in Knee OA

Recruitment & Eligibility

Status: Not yet recruiting

Sex: All

Target Recruitment: 148

Inclusion Criteria

Inclusion Criteria: - Male or female at least 30 years of age at the time of screening - Willingness and ability to comply with study procedures and visit schedules and able to follow oral and written instructions - Signed consent for study participation - Baseline NPRS = 4 points - Unilateral, symptomatic, chronic knee pain - KL grade 2 or 3 knee OA based on standing knee X-ray assessment - Body mass index = 30 kg/m2 Exclusion Criteria: - Approved anti-inflammatory therapy injections (corticosteroid, Synvisc, PRP, nSTRIDE-Autologous Protein Solution) within the previous 6 months in the knee - Major axial deviation (varus >10°, valgus >10°) - Any concomitant knee lesion causing pain or effusion (i.e., ligamentous or meniscal injury, osteochondral lesion) - Presence of clinically observed active infection in the index knee - Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, or arthritis secondary to other inflammatory diseases; chondrocalcinosis, Paget's disease, or villonodular synovitis - Diagnosed with leukemia or other hematologic cancers, known presence of metastatic malignant cells, or ongoing or planned chemotherapeutic treatment - Presence of venous or lymphatic stasis in the index leg - A history of local anesthetic allergy - Medical conditions such as hemophilia or other blood clotting disorders - Arthroscopic knee surgery within the previous 6 months - Daily opioid use for the past 3 months, use of non-steroidal anti-inflammatory drugs within 1 week of the procedure, unable to hold anti-platelet medications - Use of systemic corticosteroids for treatment of a chronic medical condition within the past 3 months - Immunosuppression or acute infective processes Study Treatment Eligibility: - For Study 1: Inability to tolerate the bone marrow aspiration procedure resulting in insufficient collection of BMA (<10 mL) after two successive aspiration attempts - For Study 2: Inability to tolerate the lipoaspiration procedure resulting in insufficient collection of LA (<40 mL) after two successive aspiration attempts

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain Level Changes. Differences in response rates between groups (treatments vs placebos) at 6-months (end of study) compared to baseline. Response is based on an improvement of 2 units or more in the Numeric Pain Rating Scale (NPRS).

Secondary Outcome Measures

Name	Time	Method
Functional Changes. Differences in mean change of Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living (ADL) subscale scores between groups (treatments vs placebos) at 6-months (end of study) compared to baseline.;Additional Pain Level Changes. Mean NPRS subscale change score at 6 months relative to baseline in treatment groups compared to placebo groups.;Additional Pain Level Changes. Mean KOOS pain subscale change score at 6 months relative to baseline in treatment groups compared to placebo groups.;Health-Related Quality of Life Changes. Mean utility and EuroQol-Visual Analogue Scale (EQ-VAS) change scores at 6 months (end of study) relative to baseline in treatment groups compared to placebo groups.;Safety. Proportion of cumulative adverse events (AEs) at 6 months post-injection in treatment groups compared to placebo groups.;Treatment Satisfaction. Percent satisfaction at 6 months in treatment groups compared to placebo groups.