Case Study:
Safety and Early Efficacy of EXO-MOVE and EXM Perinatal-Derived ECM Therapy for Knee Osteoarthritis: A 3-Participant Series with 12-Week Follow-Up
Author: Dr. Kade Hadley, DPM, DO
Affiliations: In collaboration with Utah Valley University – College of Health Science
Background: Knee osteoarthritis (OA) is a progressive degenerative joint disease with limited regenerative treatment options. Perinatal-derived extracellular matrix (ECM) biologics offer potential to modulate joint inflammation and support native repair.
Objective: To evaluate the safety, tolerability, and early efficacy of a single ultrasound-guided intra-articular injection of EXO-MOVE combined with EXM in patients with symptomatic knee OA.
Methods: Three participants with Kellgren–Lawrence grade II–III knee OA received a single injection of EXO-MOVE (1 mL) and EXM (1 mL). Patients were followed for 8 weeks. Safety, pain (VAS 0–10), and patient-reported functional outcomes were assessed.
Results: All participants tolerated treatment without adverse events. Pain scores improved from baseline (7, 6, 8) to follow-up (2, 2, 1). Patients reported enhanced mobility, reduced stiffness, and high satisfaction ratings.
Conclusion: In this small series, EXO-MOVE + EXM demonstrated short-term safety and symptomatic benefit in knee OA. Larger controlled trials are warranted.
Keywords: Osteoarthritis, Knee, Extracellular Matrix, Perinatal Allograft, Regenerative Medicine
Introduction
Knee osteoarthritis (OA) is a progressive degenerative joint disease that significantly impairs mobility and quality of life. Current management strategies are primarily symptomatic and often fail to address the underlying biologic drivers of cartilage degeneration and joint inflammation. Regenerative biologics derived from perinatal tissue have emerged as a potential alternative, providing bioactive scaffolds and signaling molecules to support native repair processes.
EXO-MOVE is a perinatal-derived extracellular matrix (ECM) flowable allograft intended for regenerative use in musculoskeletal conditions. Its mechanisms of action include providing a biologic scaffold for cellular attachment and migration, promoting angiogenesis and tissue remodeling, and modulating inflammation. Similarly, EXM is a perinatal-derived flowable allograft containing extracellular matrix, viable cells, growth factors, and bioactive proteins. Unlike single-component biologics, EXM preserves the natural architecture and cellular environment of perinatal tissue, thereby supporting structural integrity while stimulating endogenous repair.
Given their complementary mechanisms, EXO-MOVE and EXM may represent a novel, minimally invasive intra-articular therapy for symptomatic knee OA.
Objective
To evaluate the safety, tolerability, and early efficacy of a single ultrasound-guided intra-articular injection of EXO-MOVE (1 mL) combined with EXM (1 mL) in three participants with symptomatic knee OA, with follow-up extending to 12 weeks.
Methods
Participant Selection
Inclusion criteria: Adults aged 40–65 with radiographically confirmed mild-to-moderate knee OA (Kellgren–Lawrence grade II–III) and persistent pain despite conservative therapy. Exclusion criteria: Active joint infection, prior knee arthroplasty, systemic corticosteroid use within 1 month, or pregnancy/breastfeeding.
Pre-Treatment Preparation
Written informed consent obtained. Injection site prepared with chlorhexidine. Optional local anesthetic administered. Ultrasound guidance used to confirm intra-articular placement.
Treatment Protocol
EXO-MOVE + EXM (2 mL) injected via single ultrasound-guided intra-articular injection under sterile technique.
Post-Procedure Care
Patients observed for 15 minutes for immediate adverse events. Written aftercare advised mild swelling/soreness (24–72 h), avoidance of NSAIDs/alcohol (72 h), and reduced knee loading (2–3 days).
Outcome Measures
Primary: Safety/tolerability and change in VAS pain. Secondary: Self-reported function and satisfaction at 12 weeks. Pre and Post MRI
Results
Participant: (Age 60, KL grade III, baseline VAS 7): At 12 weeks, no adverse events. VAS improved to1. Improved walking distance, reduced stiffness, first time in 10 years without daily pain. Rated 'more than satisfied.
Participant 2: (Age 40, KL grade II, baseline VAS 6): At 12 weeks, no adverse events. VAS improved to 2. Reported improved stair climbing and comfort in daily activities. Rated 'very satisfied.’
Participant 3: (Age 65, KL grade II, baseline VAS 8): At 12 weeks, no adverse events. VAS improved to 2. Reported functional improvement though some evening pain persisted. Rated 'very satisfied.’
Discussion
All three participants tolerated the injection without adverse events, supporting the short-term safety of intra-articular EXO-MOVE + EXM therapy. Clinically meaningful pain reduction and functional improvements were observed within 12 weeks. While preliminary, these outcomes suggest that perinatal-derived ECM therapies may provide durable symptomatic relief and improved joint function in patients with knee OA.
Limitation
This series is limited by small sample size (n=3), lack of a control group, and reliance on subjective outcome reporting. Larger, randomized controlled trials with longer follow-up are required to validate these early findings.
Conclusion
A single ultrasound-guided intra-articular injection of EXO-MOVE combined with EXM was safe, well-tolerated, and associated with meaningful pain reduction and functional improvement through 12 weeks in patients with mild-to-moderate knee OA. These results support further investigation of perinatal-derived ECM biologics as potential disease-modifying therapies in osteoarthritis.
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