D. Saris (Rochester, US)
Mayo Clinic OrthopedicsPresenter Of 6 Presentations
1.3.3 - Surgeon vs Scientist Gap - The Surgeon Perspective
2.0.4 - Redefine the Goals of Cartilage Repair – What is Next?
18.3.6 - One-Stage Cartilage Recycling Facilitated by Adipose MSCs Safe and Clinically Effective (RECLAIM)
Abstract
Purpose
Working towards safe and reliable one stage cell-based cartilage repair requires FDA monitored IND validation of MSC facilitated cartilage repair. This study evaluates the reproducibility and novel allogeneic cell source and allows comparison to a European cohort.The purpose of this study was to assess the safety and initial clinical outcomes following REcycled CartiLage Auto/Allo IMplantation for the Treatment of Focal Knee Cartilage Defects (RECLAIM).
Methods and Materials
This was a single-arm interventional FDA IND study conducted on 25 patients with age ranging between 21 and 40 years old. Following the RECLAIM procedure, patients were queried for adverse events, clinical outcomes were evaluated using patient reported outcomes that included the KOOS (Knee injury and Osteoarthritis Outcome Score), visual analog scale for pain. Repeated measure analysis ANOVA was used to test statistical significance p<.5. Results for all treated patients with a minimum of 12 months follow up or earlier safety issue are reported.
Results
Among 13 participants who completed the 12-month follow-up there were no treatment related adverse event. Complications and adverse events were as predicted from previous studies. Participants experienced clinically relevant and statistically significant improvements in mean VAS pain and all KOOS subscales scores at 3, 6 and 12 months. (Figure1).
Conclusion
RECLAIM is a feasible one-stage cartilage regeneration option, demonstrating good safety profile and encouraging clinical outcomes in this phase 1 trial. Also, improvements in pain, function, and quality of life were achieved in this small cohort of patients with symptomatic cartilage defects of the knee. Overall, these results provide external validation and confirm comparability, safety and initial effectiveness of IMPACT and RECLAIM procedure.
22.1.2 - Clinical Therapy: Current Progress
23.1.7 - Do We Really Need PRP? Con
24.2.7 - Minced Cartilage Procedure for One-Stage Arthroscopic Repair of Chondral Defects in the Hip Joint
Abstract
Purpose
To (1) validate a harvesting technique using arthroscopic shaver to collect articular cartilage from the femoral head and to (2) compare the chondron yield and chondron viability to a manual mincing method and a device assisted mincing procedure.
Methods and Materials
Femoral heads were collected from patients with avascular necrosis of the femoral head who underwent total hip arthroplasty (THA) and processed in the laboratory. A 4.0 mm arthroscopic shaver with an attached chondral fragment capture device (GraftNet) was used to harvest the chondral surface from the area of the non-weight bearing regions of the femoral head. The cells were filtered and chondrocytes were isolated by enzymatic digestion. Cells were counted and stained with a live-dead stain and Safranin-O.
Results
16 cartilage samples were processed in total. 12 samples underwent manual processing (surgical removal of cartilage from bone by scalpel, manual mincing with scalpel or mincing device) and 4 samples were retrieved with a 4.0 mm arthroscopic shaver. The different methods produced cartilage particulate of significantly different sizes. Manual mincing with a scalpel or mincing device resulted in larger particles than shaver harvest. Cell yield and viability were comparable between the groups.
Figure 1. Chondron cluster with typical nuclei and extracellular matrix in an arthroscopic shaver sample
Figure 2. 4 chondrons in an arthroscopic shaver sample
Conclusion
The proposed harvesting method produces a high cell yield and good cell viability with a limited amount of debris. Future studies are needed to focus on short- and long-term outcomes of clinical application, as well as safety and efficacy, and to compare the results with other cartilage restoration and harvesting procedures of the hip.
Moderator Of 1 Session
Meeting Participant Of
- E. Kon (Milano, IT)
- D. Grande (Manhasset, US)
- C. Lattermann (Boston, US)
- J. Malda (Utrecht, NL)
- S. Marlovits (Vienna, AT)
- T. Minas (West Palm Beach, US)
- S. Görtz (Newton, US)
- A. Krych (Rochester, US)
- W. Kafienah (Bristol, GB)
- G. Filardo (Bologna, IT)
- I. Dallo (Sevilla, ES)
- R. Frank (Denver/Aurora, US)
- F. Sciarretta (Rome, IT)
- S. Chubinskaya (Chicago, US)
- D. Saris (Rochester, US)
- E. Papacostas (Doha, QA)
- M. McNicholas (Liverpool, GB)
- D. Saris (Rochester, US)
- T. Minas (West Palm Beach, US)
- E. Kon (Milano, IT)
- C. Lattermann (Boston, US)
- A. Gobbi (Milano, IT)
- D. Grande (Manhasset, US)
- S. Marlovits (Vienna, AT)
- M. Brittberg (Kungsbacka, SE)
- W. Bugbee (La Jolla, US)
- J. Lane (La Jolla, US)
- C. Erggelet (Zürich, CH)
- A. Krych (Rochester, US)
- F. Sciarretta (Rome, IT)
- S. Sherman (Redwood City, US)
- M. McNicholas (Liverpool, GB)
- S. Nehrer (Krems, AT)