Long-Term Results of a Phase I/II Clinical Trial of Autologous Mesenchymal Stem Cell Therapy for Femoral Head Osteonecrosis
Abstract
:1. Introduction
2. Materials and Methods
2.1. Clinical Trial Characteristics
2.2. Inclusion/Exclusion Criteria
2.3. Study Procedures
2.4. Statistical Analysis
3. Results
3.1. Patient’s Characteristics
3.2. Analysis of Adverse Events and Feasibility of the Procedure
3.3. VAS and Harris Questionnaire’s’ Results
3.4. Radiological Findings
3.5. Clinical Parameters
3.6. Need for Surgery
3.7. Long-Term Follow-up
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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SCORE | Baseline | 1-Month | 3-Months | 6-Months | 12-Months | |
---|---|---|---|---|---|---|
VAS (numerical) | 8.13 ± 1.49 | 5.75 ± 1.16 | 6.37 ± 2.37 | 5.87 ± 2.83 | 5.06 ± 3.34 | |
p (intra-group) respect to baseline | 0.018 * | 0.029 * | 0.053 | 0.051 | ||
HARRIS (pain) | 16.25 ± 11.87 | 22.50 ± 8.86 | 25.50 ± 14.80 | 21.25 ± 14.57 | 24.62 ± 15.37 | |
p (intra-group) respect to baseline | 0.049 * | 0.036 * | 0.033 * | 0.017 * | ||
HARRIS (function) | 17.62 ± 9.00 | 18.75 ± 11.27 | 21.00 ± 8.83 | 22.25 ± 6.31 | 22.25 ± 10.19 | |
p (intra-group) respect to baseline | 0.786 | 0.322 | 0.066 | 0.158 | ||
HARRIS (activity) | 8.25 ± 2.31 | 8.75 ± 2.18 | 8.25 ± 3.05 | 8.50 ± 2.97 | 9.12 ± 4.01 | |
p (intra-group) respect to baseline | 0.598 | 0.999 | 0.756 | 0.500 | ||
HARRIS (lack of deformity) | 4.00 ± 0.00 | 4.00 ± 0.00 | 4.00 ± 0.00 | 4.00 ± 0.00 | 4.00 ± 0.00 | |
p (intra-group) respect to baseline | 0.999 | 0.999 | 0.999 | 0.999 | ||
HARRIS (mobility) | 5.62 ± 0.74 | 5.87 ± 0.35 | 5.62 ± 0.74 | 6.00 ± 0.00 | 6.00 ± 0.00 | |
p (intra-group) respect to baseline | 0.451 | 0.999 | 0.197 | 0.197 | ||
HARRIS (total) | 52.00 ± 18.02 | 60.00 ± 18.74 | 64.37 ± 23.00 | 62.00 ± 21.84 | 67.00 ± 27.54 | |
p (intra-group) respect to baseline | 0.188 | 0.062 | 0.023 * | 0.014 * | ||
SF36/Physical Function | 38.75 ± 22.95 | 36.25 ± 19.04 | 43.75 ± 27.61 | 52.50 ± 33.59 | ||
p (intra-group) respect to baseline | 0.743 | 0.516 | 0.097 | |||
SF36/Physical Problems | 0.00 ± 0.00 | 6.25 ± 11.57 | 18.75 ± 34.71 | 43.75 ± 49.55 | ||
p (intra-group) respect to baseline | 0.170 | 0.170 | 0.041 * | |||
SF36/Mental Health | 50.00 ± 29.62 | 58.00 ± 30.68 | 61.50 ± 21.26 | 69.00 ± 30.37 | ||
p (intra-group) respect to baseline | 0.054 | 0.091 | 0.013 * | |||
SF36/Emotional Problems | 62.5 ± 51.75 | 57.14 ± 53.45 | 71.43 ± 48.80 | 60.00 ± 54.77 | ||
p (intra-group) respect to baseline | 0.129 | 0.356 | 0.147 | |||
SF36/Vitality, Energy or Fatigue | 35.62 ± 28.71 | 481.2 ± 24.33 | 50.00 ± 23.29 | 57.50 ± 31.51 | ||
p (intra-group) respect to baseline | 0.011 * | 0.020 * | 0.007 * | |||
SF36/General Perception Health | 38.75 ± 13.02 | 42.5 ± 13.09 | 42.5 ± 11.64 | 57.5 ± 31.50 | ||
p (intra-group) respect to baseline | 0.413 | 0.320 | 0.584 | |||
SF36/Physical Health Global | 103.75 ± 55.28 | 82.50 ± 45.96 | 110.00 ± 58.95 | 225.00 ± 161.17 | ||
p (intra-group) respect to baseline | 0.421 | 0.893 | 0.153 | |||
SF36/Mental Health Global | 181.29 ± 135.22 | 261.00 ± 143.88 | 254.75 ± 155.01 | 286.00 ± 170.99 | ||
p (intra-group) respect to baseline | 0.546 | 0.724 | 0.408 | |||
SF36/Total | 414.00 ± 161.95 | 371.75 ± 89.38 | 279.00 ± 183.50 | 399.50 ± 346.59 | ||
p (intra-group) respect to baseline | 0.188 | 0.062 | 0.014 * | |||
Hip Flexion | 116.88 ± 11.93 | 122.50 ± 13.09 | 116.88 ± 29.63 | 127.50 ± 13.89 | 124.38 ± 16.35 | |
p (intra-group) respect to baseline | 0.026 * | 0.999 | 0.031 * | 0.111 | ||
Hip Abduction | 26.25 ± 5.18 | 28.75 ± 5.84 | 28.75 ± 5.84 | 33.13 ± 5.30 | 35.00 ± 4.63 | |
p (intra-group) respect to baseline | 0.033 * | 0.451 | 0.004 * | 0.002 * | ||
Hip Adduction | 28.13 ± 4.58 | 28.13 ± 5.94 | 29.38 ± 4.17 | 33.13 ± 6.51 | 33.75 ± 5.82 | |
p (intra-group) respect to baseline | 0.999 | 0.598 | 0.068 | 0.038* | ||
Hip External Rotation | 25.00 ± 8.0.2 | 27.25 ± 6.02 | 26.88 ± 6.51 | 32.50 ± 4.63 | 34.38 ± 4.17 | |
p (intra-group) respect to baseline | 0.125 | 0.528 | 0.026 * | 0.018 * | ||
Hip Internal Rotation | 25.00 ± 8.45 | 26.25 ± 6.41 | 26.25 ± 7.44 | 27.50 ± 8.02 | 33.13 ± 6.51 | |
p (intra-group) respect to baseline | 0.351 | 0.775 | 0.470 | 0.061 | ||
Total Degrees of Mobility | 221.25 ± 25.04 | 232.88 ± 24.91 | 226.88 ± 41.14 | 253.75 ± 32.38 | 261.88 ± 32.83 | |
p (intra-group) respect to baseline | 0.032 * | 0.766 | 0.011 * | 0.004 * | ||
Radiography | Improvement | 12.5% | 12.5% | |||
Stabilization | 100% | 100% | 62.5% | 62.5% | ||
Worsening | 25% | 25% | ||||
p (intra-group) respect to the first month | 0.999 | 0.317 | 0.317 | |||
Magnetic Resonance Imaging (ARCO) | IA | 25% | 25% | 25% | ||
IIA | 25% | 25% | 25% | |||
IIB | 50% | 37.5% | 37.5% | |||
IIIA | 12.5% | 12.5% | ||||
p (intra-group) respect to baseline | 0.467 | 0.467 | ||||
Clinic | Best | 87.5% | 100% | 62.5% | 50% | |
Same | 12.5% | 25% | 37.5% | |||
Worst | 12.5% | 12.5% | ||||
p (intra-group) respect to the first month | 0.317 | 0.157 | 0.083 |
ID | Date | Side | Time to THR (Days) | Side to THR |
---|---|---|---|---|
1 | 10 August 2012 | Right | 558 | Right |
2 | 20 February 2013 | Right | ||
3 | 10 April 2013 | Right | 576 | Right |
790 | Left | |||
4 | 9 May 2013 | Left | 1857 | Left |
5 | 12 August 2013 | Left | ||
6 | 23 September 2013 | Left | 574 | Left |
1346 | Right | |||
7 | 2 June 2014 | Left | 574 | Right |
8 | 8 October 2014 | Left |
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Blanco, J.F.; Garcia-Garcia, F.J.; Villarón, E.M.; da Casa, C.; Fidalgo, H.; López-Parra, M.; Santos, J.A.; Sánchez-Guijo, F. Long-Term Results of a Phase I/II Clinical Trial of Autologous Mesenchymal Stem Cell Therapy for Femoral Head Osteonecrosis. J. Clin. Med. 2023, 12, 2117. https://doi.org/10.3390/jcm12062117
Blanco JF, Garcia-Garcia FJ, Villarón EM, da Casa C, Fidalgo H, López-Parra M, Santos JA, Sánchez-Guijo F. Long-Term Results of a Phase I/II Clinical Trial of Autologous Mesenchymal Stem Cell Therapy for Femoral Head Osteonecrosis. Journal of Clinical Medicine. 2023; 12(6):2117. https://doi.org/10.3390/jcm12062117
Chicago/Turabian StyleBlanco, Juan F., Francisco J. Garcia-Garcia, Eva M. Villarón, Carmen da Casa, Helena Fidalgo, Miriam López-Parra, José A. Santos, and Fermín Sánchez-Guijo. 2023. "Long-Term Results of a Phase I/II Clinical Trial of Autologous Mesenchymal Stem Cell Therapy for Femoral Head Osteonecrosis" Journal of Clinical Medicine 12, no. 6: 2117. https://doi.org/10.3390/jcm12062117
APA StyleBlanco, J. F., Garcia-Garcia, F. J., Villarón, E. M., da Casa, C., Fidalgo, H., López-Parra, M., Santos, J. A., & Sánchez-Guijo, F. (2023). Long-Term Results of a Phase I/II Clinical Trial of Autologous Mesenchymal Stem Cell Therapy for Femoral Head Osteonecrosis. Journal of Clinical Medicine, 12(6), 2117. https://doi.org/10.3390/jcm12062117