2019 Trial: Adipose Therapy Significantly Reduces Pain and Shows New Cartilage Signal in Knee Osteoarthritis (OA)
Introduction
If knee osteoarthritis has been shrinking your world – shorter walks, fewer rounds of golf, restless nights – you’re not alone. Many Canadians want something between “more pills” and “eventual surgery.” A 2019 clinical trial followed patients for two years after a single injection of adipose (fat) tissue and found MRI signals consistent with improved cartilage composition alongside dramatic reductions in pain. This study examined micro-fragmented adipose tissue – a biologic approach that shares foundational similarities with Regenerative Matrix Therapy™, RMIC’s next-generation treatment. Our protocol was reviewed by Health Canada with no objection and is delivered in a physician-led setting focused on safety and outcomes.
Context / Problem
Osteoarthritis (OA) goes beyond just “wear and tear” – it’s a whole-joint disease affecting cartilage, bone, intra-articular tissue, and synovium. Standard X-rays miss early biochemical changes, which is why modern research often uses MRI methods that can detect “pre-morphologic” changes in cartilage. One such tool is dGEMRIC, an MRI technique that estimates glycosaminoglycan (GAG) content – a marker of cartilage health – giving researchers a quantitative way to track cartilage integrity over time.
Study Overview
Researchers in Croatia conducted a prospective, single-centre, open-label clinical trial in patients with moderate-to-severe knee OA (Kellgren–Lawrence grade III–IV). Seventeen patients (32 knees at 12 months) received one intra-articular injection of autologous micro-fragmented adipose tissue prepared with a standardized mechanical system; ten patients (18 knees) completed the 24-month follow-up. Assessments occurred at baseline and 3, 6, 12, and 24 months, using dGEMRIC to evaluate cartilage GAG content, plus visual analog scale (VAS) pain scores and orthopedic exam. The study was IRB-approved and registry-listed (ISRCTN13337022).
Primary endpoint: Change in dGEMRIC index (a proxy for cartilage GAG content) across seven predefined knee joint facets.
Secondary endpoints: Pain (VAS) and standard exam findings.
Key Findings
- Cartilage composition signal: Two years after injection, 64.2% of clinically relevant facet measurements (≥15% change) showed improvement in dGEMRIC index (12 of 19), while 36.8% declined (7 of 19). The average magnitude of increases was +32.3% ± 21.9%, exceeding the average magnitude of decreases −16.2% ± 1.5% (absolute-value comparison, P = 0.028).
- Pain improved dramatically: VAS (0-10 scale) pain scores showed an 88% improvement in pain at rest (4.45 → 0.55) and a 56% improvement in pain with activity (7.73 → 3.40).
- Compartment-specific patterns: Improvements were more common laterally (lateral tibial and femoral condyles), while medial compartment facets tended to decline in patients with varus alignment – consistent with higher load on the medial knee. Advanced, full-thickness cartilage loss (ICRS grade IV) did not show dGEMRIC improvements.
What This Means for You
For patients aiming to delay or avoid surgery, this trial showed meaningful symptom relief: on a 0–10 scale, resting pain fell from 4.45 to 0.55 (88% improvement) and pain with activity dropped from 7.73 to 3.40 (56% improvement) after 2 years after a single adipose injection.
Many joint regions also showed MRI-based signals consistent with healthier cartilage composition. Medial compartments under varus load improved less though – underscoring the importance of alignment and a tailored rehab plan alongside treatment.
Regenerative Matrix Therapy™ is RMIC’s next-generation, tissue-based biologic delivered through a standardized, physician-led protocol that Health Canada reviewed with no objection. The trial summarized here evaluated a related approach; its pain reductions and MRI signals align with the scientific foundations behind our protocol, but Regenerative Matrix Therapy™ was not studied here. RMIC does not claim cartilage regeneration or imaging changes with Regenerative Matrix Therapy™ – our clinical focus is helping you reduce pain, restore function, and get back to the activities you love.
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Research Highlights
Study Design: Prospective, single-centre, open-label trial; n = 17 patients (32 knees at 12 mo); 10 patients (18 knees) completed 24 mo. One intra-articular injection of autologous micro-fragmented adipose tissue (Lipogems®), 4–15 mL. Primary outcome: dGEMRIC index across seven facets; secondary: VAS pain. IRB approved; ISRCTN13337022.
P-Values / Effect Sizes:
• Clinically relevant change threshold: ≥15% (based on ~7% measurement variability).
• At 24 mo, 12/19 relevant facet measurements improved (64.2%), 7/19 decreased (36.8%); difference in frequency not significant (P = 0.251).
• Magnitude of change favored improvement: mean increase +32.3% ± 21.9% vs mean decrease −16.2% ± 1.5% (P = 0.028, absolute values).
• VAS (0–10): Resting 4.45 → 0.55 (−3.9; −88%; p<0.001). Activity 7.73 → 3.40 (−4.33; −56%; p<0.001).
Limitations: Open-label, non-randomized, no control arm; small 24-month cohort (n = 10; 18 knees) with drop-outs; dGEMRIC is a surrogate biomarker; single centre; mechanical alignment (varus) likely confounded medial compartment results; severe (ICRS IV) lesions showed no dGEMRIC improvement.
Citation:
Borić I, Hudetz D, Rod E, et al. A 24-Month Follow-Up Study of the Effect of Intra-Articular Injection of Autologous Microfragmented Fat Tissue on Proteoglycan Synthesis in Patients with Knee Osteoarthritis. Genes. 2019;10:1051. doi:10.3390/genes10121051.
Disclaimer
Regenerative Matrix Therapy™ shares foundational similarities with, but is not identical to, the treatment studied. RMIC does not claim that Regenerative Matrix Therapy™ regenerates cartilage or improves cartilage imaging biomarkers; any discussion of cartilage pertains to the cited study and is provided for education only. Individual results vary. Educational content only; not a substitute for professional medical advice.
Notes for Clinically-Minded Readers
- Why dGEMRIC? It’s sensitive to GAG content and can detect pre-morphologic changes sooner than standard imaging, making it useful for tracking cartilage biochemistry over time.
- Responder pattern: Lateral facets more often improved; medial facets under varus load often decreased – consistent with load-dependent biology; alignment remains a key modulator of response.
- Lesion severity ceiling: No dGEMRIC gains in ICRS IV lesions, underscoring the importance of timely intervention.
Why choose Regenerative Matrix Therapy™ with RMIC?
Regenerative Matrix Therapy™ applies a standardized, physician-led protocol designed to harness the restorative potential of your own adipose tissue within a care pathway built for safety, consistency, and outcomes. While not identical to the intervention above, it shares core scientific principles and is performed in clinics operating under rigorous clinical governance. Our treatment protocol was reviewed by Health Canada with no objection, and candidacy is evaluated through a thorough consultation to align expectations, biomechanics, and rehabilitation for the best possible result.