E. Kon (Milano, IT)

Humanitas University

Presenter Of 7 Presentations

Extended Abstract (for invited Faculty only) Others

6.1.1 - Consortium-Based Grants

Presentation Number
6.1.1
Presentation Topic
Others
Lecture Time
07:30 - 07:50
Session Type
Instructional Course / Workshop
Corresponding Author
Podium Presentation Platelet Rich Plasma and Growth factors

12.4.4 - Duration effects of a single intra-articular injection of Autologous Protein Solution (APS) in patients with knee osteoarthritis (OA)

Presentation Number
12.4.4
Presentation Topic
Platelet Rich Plasma and Growth factors
Lecture Time
17:27 - 17:36
Session Name
Session Type
Free Paper Session
Corresponding Author
Disclosure
L.E, Arthrex, Biomet, Smith & Nephew, research support; Arthrex, consultant; iBalance, shareholder G.F, Cartiheal, Finceramica, GreenBone, presenter; IGEA, BIOMET, Kensey Nash, Finceramica, Fidia, Cartiheal, EON, research support E.K, Biomet, Fidia, Fince

Abstract

Purpose

Autologous anti-inflammatories (AAI) are a class of blood-derived products with high concentrations of anti-inflammatory cytokines that are currently being investigated for the treatment of mild to moderate knee osteoarthritis (OA) to determine if they can ameliorate symptoms longer or better than traditional intra-articular injections such as hyaluronic acid (HA) and steroids. The purpose of this evaluation is to determine the duration of effect from a single injection of APS before patients elect a new treatment course.

Methods and Materials

Forty-six patients underwent a 2:1 randomization process to either one single injection of APS (n=31) or saline (n=15) (NCT02138890). APS was prepared with the nSTRIDE APS Kit (Zimmer Biomet). The 12 month double-blind outcomes of the double-blind portion of the trial were previously published. The APS cohort was asked to participate in unblinded long-term follow-up. Efficacy endpoints of pain and function over time (WOMAC LK 3.1, KOOS, and VAS) were measured as a change from baseline to each time point. Quality of life (SF-36), OMERACT-OARSI responder criteria, rescue medication usage, as well as yearly x-rays and 24 month MRI imaging were completed.

Results

Survivorship of the APS cohort that agreed to long-term follow-up was 71% at 3 years. At 36 months, the mean WOMAC Pain improvement was 70%(Figure 2)(7.8 ± 4.0) in the APS cohort, which was a significant improvement compared to the baseline score(p<0.0001). APS cohort patients also showed a statistically significant improvement in their KOOS pain score (114%,33.3 ± 22.0; p<0.0001) and VAS pain score (42.7%, 2.0 ± 3.3; p=0.0012).

Conclusion

Intra-articular injections of APS for mild to moderate knee OA was safe and a portion of patients continue to have pain relief 3 years after a single injection. Clinical investigation (NCT03182374) to determine the long-term efficacy compared to a single injection hyaluronic acid is currently ongoing.

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Extended Abstract (for invited Faculty only)

15.3.3 - Randomized Trials Vs. Cohort Studies

Presentation Number
15.3.3
Lecture Time
10:25 - 10:45
Session Name
Session Type
Special Session
Corresponding Author
Podium Presentation Biomaterials and Scaffolds

16.2.2 - A wood-derived biomimetic scaffold for segmental bone reconstruction: Pre-clinical safety and performance assessment in a sheep model

Abstract

Purpose

To assess safety and performance of a bone substitute (GreenboneTM) obtained by biomorphic transformation of natural wood into 3D biomimetic substituted calcium phosphate (hydroxyapatite and b-tricalciumphosphate) scaffold for segmental bone reconstruction in sheep model

Methods and Materials

The study evaluated bone implant in 24 sheep randomized to three groups, Greenbone scaffold I, Greenbone scaffold II, and allograft, followed up to 6 months. Bony defects were created in the metatarsus and the scaffold was inserted. Safety assessment considered any AE, macroscopic presentation and treatment-related abnormalities (popliteal lymph nodes histopathology). Performance (cumulative score for callus formation, new bone and implant resorption) was assessed by X-ray or CT and by ex vivo analyses after implant retrieval including microCT, macroscopic, and histological and histomorphometric assessments. Further bone biopsies were conducted for assessing mechanical, osteogenic, osteoclastic and angiogenic characteristics of newly formed bone

Results

Observations confirmed osteoinductive properties for Greenbone scaffolds. Medullary bone formation was observed for the Greenbone groups only, already at month 3. Both interfaces of the scaffolds were covered by newly formed bone, without interposition of fibrous connective tissue in the most internal part of the scaffolds, with the new osteonic systems and newly formed blood vessels; many osteocytes and osteoblasts lining the edges of the calcified structures and outbreaks of osteoclastic resorption on the scaffolds. Presence of bone callous containing micro vessels and osteoblasts was seen in most of the samples. Cortical volume and thickness were similar among groups. Both GB I (p=0.0092) and GBII (p=0.014) scaffolds presented higher OS/BS values vs AG-allograft, with highest OSTh and Ob/BS for GBI-doped with ions compared to GBII HA only non doped and AG. Implant resorption started after the first month.

Conclusion

The present study has confirmed Greenbone's characteristics in terms of biocompatibility, mechanical properties and bioresorbability to provide a safe and highly performing bone substitute for segmental bone reconstruction

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Extended Abstract (for invited Faculty only) Clinical Outcome

17.4.3 - Clinical Outcomes: Treating Focal Lesions, Osteochondral Defects & Osteoarthritis Using Agili-C™

Presentation Number
17.4.3
Presentation Topic
Clinical Outcome
Lecture Time
13:40 - 14:00
Session Type
Industry Satellite Symposium
Corresponding Author
Extended Abstract (for invited Faculty only) Cartilage /Cell Transplantation

22.0.6 - Cells not Required

Presentation Number
22.0.6
Presentation Topic
Cartilage /Cell Transplantation
Lecture Time
09:25 - 09:30
Session Type
Plenary Session
Corresponding Author
Podium Presentation Stem Cells

23.3.5 - Characterization of Bone Marrow Aspirate obtained by Marrow Cellution device: the smartest way to collect Bone Marrow

Presentation Number
23.3.5
Presentation Topic
Stem Cells
Lecture Time
11:06 - 11:15
Session Type
Free Paper Session
Corresponding Author
Disclosure
No Significant Commercial Relationship

Abstract

Purpose

Bone marrow aspirate (BMA) is a promising treatment for knee OA. BMA contains a small percentage of stem cells, and this number is affected by quality of tissue harvesting, depending on the use of multiple aspiration sites with the collection of small volumes. Marrow-Cellution allows collecting high quality BMA using one access site, reducing harvesting time and procedure-related risks. The purpose of this study is to evaluate the mesenchymal (MSC) and hemopoietic (HSC) stem cells content in Marrow-Cellution-obtained BMA and its efficacy in an in vitro model of cartilage inflammation. These results will be compared with clinical outcomes of donor patients, undergoing intra-articular BMA injection.

Methods and Materials

BMA was obtained from iliac crest and tibia of 9 patients using Marrow-Cellution. Cell count, viability and percentage of stem cells was determined. A model of cartilage inflammation was established using IL-1β to stimulate human chondrocytes. Proliferation and immunophenotype of BMA cultured cells were assessed.

Results

The expected concentration of nucleated cells in native bone marrow is 1.5-3.0x107 cells/ml. BMA from iliac crest revealed a total count of 1.3x107 cells/ml, while 4x106 cells/ml were found in the matched BMA from tibia. The percentage of HSCs and MSCs in BMA from iliac crest resulted 1.2% and 0.009%, respectively, similar to native bone marrow (1.5% HSCs, 0.01% MSCs). Tibia samples showed 0.06% HSCs and 0.002% MSCs. BMA cells proliferate in culture and possess the MSCs immunophenotype. BMA reduced the expression of catabolic markers in IL-1β-treated chondrocytes.

Conclusion

Marrow-Cellution allows collecting high quality BMA from iliac crest, showing similar cell count and percentage of stem cells as native bone marrow. The model of cartilage inflammation provided insights in BMA mechanism of action. The comparison of these results with the clinical outcomes will provide evidences about the BMA quality standards required to obtain significant results in the orthopedic practice.

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Meeting Participant of

Lord Byron - ICRS Meeting Room (20) ICRS Committee Meeting

ICRS Diamond Partners

Session Type
ICRS Committee Meeting
Date
07.10.2019
Time
11:00 - 12:00
Location
Lord Byron - ICRS Meeting Room (20)
Lord Byron - ICRS Meeting Room (20) ICRS Committee Meeting

Executive Board (Actual Board)

Session Type
ICRS Committee Meeting
Date
05.10.2019
Time
08:45 - 10:00
Location
Lord Byron - ICRS Meeting Room (20)