Phase 4 N=90 Randomized Treatment

Bone Marrow Aspirate Compared to Platelet Rich Plasma for Treating Knee Osteoarthritis

Knee Osteoarthritis

Bottom Line

View on ClinicalTrials.gov: NCT03289416 ↗

Enrolled (actual)

Serious AEs

2.2%

Results posted

Apr 2025

Primary outcome: Primary: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements — 32.1; 35.3; 19.5; 19.8 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Pure PRP II (Combination_product); PureBMC (Combination_product)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Andrews Research & Education Foundation
Primary completion: Feb 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements	32.1; 35.3; 19.5; 19.8; 18.2; 15.2	—
SECONDARY Subjective International Knee Documentation Committee Subjective Score (IKDC)	47.4; .909; 58.4; 58.5; 61.6; 63.6	—

Summary

This study is intended to compare whether bone marrow aspirate concentrate or platelet rich plasma injections is more effective in treating knee osteoarthritis.

Eligibility Criteria

Inclusion Criteria

Male or female age 18-80 years
Knee osteoarthritis
Subjects must present with pain or swelling to target knee for at least 4 months
Kellgren-Lawrence score between 1 and 3 upon x-ray evaluation
Must be willing and able to provide informed consent
Willing and able to return for scheduled follow-up visits

Exclusion Criteria

Major mechanical axis deviation of more than 50% into either compartment (varus or valgus )
Have had a corticosteroid injection within 3 months or a hyaluronic acid injection within 6 months
History of the following medical conditions:
diabetes
autoimmune disorders
disorders requiring immunosuppression
rheumatoid arthritis
hemophilic arthropathy
infectious arthritis
Charcot's knee
Paget's disease of the femur or tibia
Cancer
Ongoing infectious disease
Significant cardiovascular, renal or hepatic disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03289416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.