ILB® Attenuates Clinical Symptoms and Serum Biomarkers of Oxidative/Nitrosative Stress and Mitochondrial Dysfunction in Patients with Amyotrophic Lateral Sclerosis
Abstract
:1. Introduction
2. Materials and Methods
2.1. Trial Oversight
2.2. Patients and Controls
2.3. Clinical Assessment of Patients with ALS Using the ALSFRS-R
2.4. Investigational Medicinal Product (IMP), Dosing and Administration
2.5. Serum Sampling
2.6. List of ALS Patient Samples, Sample Processing and Analyses
2.7. Statistics
3. Results
3.1. Raw Data
3.2. ILB® Improves Patients’ Clinical Conditions and Decreases Neuronal Damage and Energy Metabolism Impairment
3.3. ILB® Decreases ALS-Related Oxidative/Nitrosative Stress
3.4. ILB® Ameliorates ALS-Induced Changes of Serum Amino Acids
3.5. ILB® Improves the Pattern of Circulating Fat-Soluble Antioxidants
4. Discussion
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Sample Number | Subject Number and Sampling Time |
---|---|
1 | Subject 101, Day 0 |
2 | Subject 101, Day 36 |
3 | Subject 102, Day 0 |
4 | Subject 10, Day 36 |
5 | Subject 103, Day 0 |
6 | Subject 103, Day 36 |
7 | Subject 104, Day 0 |
8 | Subject 104, Day 36 |
9 | Subject 105, Day 0 |
10 | Subject 105, Day 36 |
11 | Subject 106, Day 0 |
12 | Subject 106, Day 36 |
13 | Subject 107, Day 0 |
14 | Subject 107, Day 36 |
15 | Subject 108, Day 0 |
16 | Subject 108, Day 36 |
17 | Subject 109, Day 0 |
18 | Subject 109, Day 36 |
19 | Subject 110, Day 0 |
20 | Subject 110, Day 36 |
21 | Subject 111, Day 0 |
22 | Subject 111, Day 36 |
23 | Subject 112, Day 0 |
24 | Subject 112, Day 36 |
25 | Subject 113, Day 0 |
26 | Subject 113, Day 36 |
Day | ALSFRS-R ± SD |
---|---|
0 (Pre-treatment) | 36.1 ± 6.7 |
29 (Final treatment) | 39.2 ± 6.3 * |
36 (Post-treatment) | 40.9 ± 6.9 ** |
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Lazzarino, G.; Mangione, R.; Belli, A.; Di Pietro, V.; Nagy, Z.; Barnes, N.M.; Bruce, L.; Ropero, B.M.; Persson, L.I.; Manca, B.; et al. ILB® Attenuates Clinical Symptoms and Serum Biomarkers of Oxidative/Nitrosative Stress and Mitochondrial Dysfunction in Patients with Amyotrophic Lateral Sclerosis. J. Pers. Med. 2021, 11, 794. https://doi.org/10.3390/jpm11080794
Lazzarino G, Mangione R, Belli A, Di Pietro V, Nagy Z, Barnes NM, Bruce L, Ropero BM, Persson LI, Manca B, et al. ILB® Attenuates Clinical Symptoms and Serum Biomarkers of Oxidative/Nitrosative Stress and Mitochondrial Dysfunction in Patients with Amyotrophic Lateral Sclerosis. Journal of Personalized Medicine. 2021; 11(8):794. https://doi.org/10.3390/jpm11080794
Chicago/Turabian StyleLazzarino, Giacomo, Renata Mangione, Antonio Belli, Valentina Di Pietro, Zsuzsanna Nagy, Nicholas M. Barnes, Lars Bruce, Bernardo M. Ropero, Lennart I. Persson, Benedetta Manca, and et al. 2021. "ILB® Attenuates Clinical Symptoms and Serum Biomarkers of Oxidative/Nitrosative Stress and Mitochondrial Dysfunction in Patients with Amyotrophic Lateral Sclerosis" Journal of Personalized Medicine 11, no. 8: 794. https://doi.org/10.3390/jpm11080794