Autologous Matrix-Induced Chondrogenesis (AMIC) and AMIC Enhanced by Autologous Concentrated Bone Marrow Aspirate (BMAC) Allow for Stable Clinical and Functional Improvements at up to 9 Years Follow-Up: Results from a Randomized Controlled Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Patients
2.2. Surgical Technique
2.3. Flow Cytometry of Bone Marrow Concentrate-Derived Mesenchymal Stem Cells
2.4. Clinical Evaluation
2.5. Magnetic Resonance Imaging (MRI) Protocol
2.6. Rehabilitation Protocol
2.7. Statistical Analysis
3. Results
3.1. Patients
3.2. Bone Marrow Cells Analysis
3.3. Demographic Data at Baseline
3.4. Functional and Clinical Outcomes
3.5. Radiological Observations
4. Discussion
5. Conclusions
Author Contributions
Funding
Conflicts of Interest
References
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Marker | Percentage of Positive Cells |
---|---|
CD34 | 0.8% ± 1.1% |
CD45 | 1.7% ± 1.8% |
CD105 | 98.9% ± 3.2% |
CD73 | 99.5% ± 2.7% |
CD166 | 98.3% ± 2.9% |
CD90 | 99.3% ± 3.1% |
AMIC | AMIC+ | p | |
---|---|---|---|
Age (years) | 30.0 ± 10.2 | 30.0 ± 11.3 | ns |
Sex | 7M/5F | 8M/4F | ns |
Weight (kg) | 69.1 ± 11.5 | 68.8 ± 12.9 | ns |
Lesion size (cm2) | 3.8 ± 1.0 | 3.4 ± 0.8 | ns |
VAS pre-op | 5.6 ± 2.2 | 6.3 ± 2.6 | ns |
Lysholm pre-op | 72.2 ± 14.2 | 64.5 ± 16 | ns |
Tegner pre-injury | 6.2 ± 1.7 (range 3–9) | 6.0 ± 1.8 (range 3–9) | ns |
IKDC | A + B: 84%; C + D: 16% | A + B: 67%; C + D: 23% | ns |
Localization | 7 MFC, 3 LFC, 2 PFJ | 6 MFC, 2 LFC, 4 PFJ | |
Traumatic lesions | 2 | 2 | |
Previous surgery | 6 (DA, TTM, PM, ACLR, PM + DB) | 3 (DA, DB, DA + LB) | |
Combined procedures | 3 (TTM, DB grade II lesion, ACLT) | 1 (TTM) |
LYSHOLM SCORE | VAS | TEGNER | |||||||
---|---|---|---|---|---|---|---|---|---|
AMIC | AMIC+ | n | AMIC | AMIC+ | n | AMIC | AMIC+ | n | |
Pre-op | 72.3 ± 13.3 (44–89) | 65.2 ± 16.0 (33–80) | AMIC 12; AMIC+ 12 | 5.8 ± 2.2 (2–8) | 6.6 ± 2.7 (1–10) | AMIC 12; AMIC+ 12 | 4.7 ± 2.8 (2–9) | 4.3 ± 2.5 (1–9) | AMIC 11; AMIC+ 12 |
6 months | 84.2 ± 10.6 (64–100) | 90.4 ± 6.6 (80–100) | AMIC 12; AMIC+ 11 | 3.3 ± 1.8 (0–7) | 1.9 ± 1.4 (0–8) | AMIC 12; AMIC+ 11 | 4.5 ± 2.0 (3–9) | 3.6 ± 0.9 (2–5) | AMIC 11; AMIC+ 11 |
12 months | 84.0 ± 10.6 (65–100) | 93.9 ± 6.2 (78–100) | AMIC 11; AMIC+ 11 | 3.0 ± 1.8 (0–6) | 1.1 ± 1.3 (0–3.5) | AMIC 11; AMIC+ 11 | 5.6 ± 1.9 (2–9) | 5.0 ± 1.8 (3–9) | AMIC 11; AMIC+ 11 |
24 months | 93.1 ± 4.3 (90–100) | 96.1 ± 3.8 (88–100) | AMIC 10; AMIC+ 10 | 0.8 ± 0.9 (0–2) | 0.6 ± 0.8 (0–2) | AMIC 10; AMIC+ 10 | 6.3 ± 2.2 (3–10) | 5.4 ± 2.0 (2–9) | AMIC 10; AMIC+ 10 |
60 months | 88.3 ± 9.6 (70–100) | 91.4 ± 7.2 (76–100) | AMIC 10; AMIC+ 10 | 0.9 ± 1.4 (0–4) | 1.2 ± 1.3 (0–4) | AMIC 10; AMIC+ 10 | 5.6 ± 1.4 (3–7) | 5.0 ± 2.2 (2–9) | AMIC 10; AMIC+ 10 |
100 months | 85.6 ± 9.4 (73–100) | 89.1 ± 6.0 (80–100) | AMIC 7; AMIC+ 9 | 2.7 ± 2.8 (0–8) | 0.9 ± 1.1 (0–3) | AMIC 7; AMIC+ 9 | 4.9 ± 2.5 (1–8) | 4.7 ± 1.3 (3–7) | AMIC 7; AMIC+ 9 |
Pre-injury | - | - | - | - | - | - | 6.2 ± 1.7 (3–9) | 6.0 ± 1.8 (3–9) | AMIC 9; AMIC+ 12 |
AMIC | AMIC+ | ||||||
---|---|---|---|---|---|---|---|
6 Months | 12 Months | 24 Months | 6 Months | 12 Months | 24 Months | ||
n = 9 | n = 5 | n = 2 | n = 11 | n = 11 | n = 9 | ||
Defect filling | None | 0 | 0 | 0 | 1 | 0 | 0 |
<1/3 | 4 | 1 | 0 | 5 | 2 | 1 | |
1/3–2/3 | 5 | 3 | 1 | 5 | 3 | 2 | |
>2/3 | 0 | 1 | 1 | 0 | 4 | 6 | |
Surface | Largely uneven | 6 | 2 | 1 | 2 | 1 | 0 |
Partially uneven | 2 | 3 | 1 | 9 | 7 | 4 | |
Smooth | 1 | 0 | 0 | 0 | 3 | 5 | |
Signal intensity of defect cover | Hyper | 0 | 1 | 1 | 0 | 0 | 0 |
Iso | 1 | 1 | 0 | 5 | 8 | 9 | |
Hypo | 6 | 3 | 1 | 6 | 3 | 0 | |
Integration | Marginal gap up 50% | 3 | 3 | 0 | 0 | 0 | 0 |
Marginal gap | 3 | 0 | 1 | 2 | 7 | 5 | |
Complete | 3 | 2 | 0 | 6 | 4 | 4 | |
Not evaluable | 0 | 0 | 1 | 3 | 0 | 0 | |
Bone marrow lesion | >2 cm | 1 | 0 | 0 | 1 | 1 | 1 |
1–2 cm | 1 | 0 | 0 | 3 | 1 | 0 | |
<1 cm | 6 | 4 | 2 | 5 | 9 | 7 | |
None | 0 | 0 | 0 | 0 | 0 | 1 | |
Not evaluable | 1 | 1 | 0 | 0 | 0 | 0 |
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de Girolamo, L.; Schönhuber, H.; Viganò, M.; Bait, C.; Quaglia, A.; Thiebat, G.; Volpi, P. Autologous Matrix-Induced Chondrogenesis (AMIC) and AMIC Enhanced by Autologous Concentrated Bone Marrow Aspirate (BMAC) Allow for Stable Clinical and Functional Improvements at up to 9 Years Follow-Up: Results from a Randomized Controlled Study. J. Clin. Med. 2019, 8, 392. https://doi.org/10.3390/jcm8030392
de Girolamo L, Schönhuber H, Viganò M, Bait C, Quaglia A, Thiebat G, Volpi P. Autologous Matrix-Induced Chondrogenesis (AMIC) and AMIC Enhanced by Autologous Concentrated Bone Marrow Aspirate (BMAC) Allow for Stable Clinical and Functional Improvements at up to 9 Years Follow-Up: Results from a Randomized Controlled Study. Journal of Clinical Medicine. 2019; 8(3):392. https://doi.org/10.3390/jcm8030392
Chicago/Turabian Stylede Girolamo, Laura, Herbert Schönhuber, Marco Viganò, Corrado Bait, Alessandro Quaglia, Gabriele Thiebat, and Piero Volpi. 2019. "Autologous Matrix-Induced Chondrogenesis (AMIC) and AMIC Enhanced by Autologous Concentrated Bone Marrow Aspirate (BMAC) Allow for Stable Clinical and Functional Improvements at up to 9 Years Follow-Up: Results from a Randomized Controlled Study" Journal of Clinical Medicine 8, no. 3: 392. https://doi.org/10.3390/jcm8030392