Efficacy and Safety of Icariin Capsules in Intervening Post-operative Bone Grafting for Hip Osteonecrosis in ARCO Stage II
Original Article | Vol 5 | Issue 2 | July-December 2025 | page: 13-19 | Yuanzhuo Xu, Yu Zhou, Wei Sun, Fuqiang Gao
DOI: https://doi.org/10.13107/jrs.2025.v05.i02.173
Open Access License: CC BY-NC 4.0
Copyright Statement: Copyright © 2025; The Author(s).
Submitted Date: 19 Oct 2025, Review Date: 18 Nov 2025, Accepted Date: Nov 2025 & Published: 30 Dec 2025
Author: Yuanzhuo Xu [1], Yu Zhou1 [1,2,3], Wei Sun [4], Fuqiang Gao [1,2,3]
[1] Department of Orthopedic Surgery, China-Japan Friendship Hospital (Institute of Clinical Medical Sciences), Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China,
[2] Department of Orthopaedic Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA,
[3] Center for Hip Preservation, Osteonecrosis and Developmental Dysplasia of the Hip, China-Japan Friendship Hospital, Beijing, China,
[4] Department of Orthopedic Surgery, Capital Medical University, China-Japan Friendship School of Clinical Medicine, Beijing, China.
Address of Correspondence
Dr. Wei Sun,
Department of Orthopaedic Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA.
E-mail: wei.sun@pennmedicine.upenn.edu
Abstract
Introduction: Both hip-preserving surgery and pharmacological therapy can effectively improve symptoms in patients with early-stage osteonecrosis of the femoral head (ONFH) and are expected to delay the need for total hip arthroplasty. However, the clinical efficacy of combining hip-preserving surgery with drug therapy has not yet been widely substantiated. Therefore, we conducted a randomized clinical trial to compare the clinical outcomes of impacted bone graft (IBG) combined with Icariin (ICA) versus IBG alone.
Purposes: The aim of this study was to clinically observe and evaluate the interventional therapeutic effect of ICA in patients with corticosteroid-induced ONFH following hip-preserving surgery, by comparing the femoral head collapse rate with a placebo control group, thereby providing a reliable basis for expanding the clinical application indications of ICA.
Materials and Methods: This was a prospective randomized clinical trial. Patients with early-stage steroid-induced ONFH (ARCO stage II) who underwent hip-preserving surgery were eligible. Between September 2021 and August 2022, we randomized 46 patients to receive either IBG plus ICA or IBG alone. At the 1-year follow-up, 87% of patients (20 out of 23) in both the IBG+ICA and IBG groups were available for assessment. The observed indicators included patient-reported outcome measures ([PROMs], including Harris Hip Score [HHS], the 36-item short form health survey [SF-36], and Visual Analog Scale [VAS]) and the progression of femoral head collapse on imaging, assessed preoperatively and within 1 year postoperatively. No significant differences were noted in baseline characteristics such as age, gender, affected side, and PROMs between the two groups.
Results: We found no statistically significant difference in the improvement of the HHS (4.7 ± 3.6 vs. 4.0 ± 3.5, respectively; mean difference 0.7 [95% confidence interval [CI] −1.5–3.0]; P = 0.505) or the VAS score (0.28 ± 0.29 vs. 0.14 ± 0.25, respectively; mean difference 0.14 [95% CI −0.03–0.32]; P = 0.099) between the IBG + ICA group and the IBG group at 3 months postoperatively. However, significant differences began to emerge by 6 months postoperatively (HHS at 6 months: 8.4 ± 3.0 vs. 5.4 ± 2.8, respectively; mean difference 3.0 [95% CI 1.1–4.8]; P = 0.003; HHS at 12 months: 10.8 ± 3.3 vs. 7.7 ± 3.4, respectively; mean difference 3.1 [95% CI 1.0–5.3]; P = 0.005; VAS at 6 months: 0.48 ± 0.27 vs. 0.30 ± 0.17, respectively; mean difference 0.18 [95% CI 0.03–0.32]; P = 0.021; VAS at 12 months: 0.84 ± 0.26 vs. 0.50 ± 0.25, respectively; mean difference 0.34 [95% CI 0.18–0.51]; P < 0.001). Furthermore, the IBG+ICA group demonstrated a significantly greater improvement in the SF-36 score at 12 months postoperatively compared to the IBG group (7.9 ± 3.1 vs. 3.5 ± 3.2, respectively; mean difference 4.4 [95% CI 2.4–6.4]; P < 0.001). No significant difference in the progression of femoral head collapse was observed between the two groups. Furthermore, no drug-related adverse reactions were reported.
Conclusion: Based on the 1-year follow-up of the two groups of patients and the analysis results, IBG + ICA did not bring more significant clinical symptom improvement to the patients compared to IBG at 3 months postoperatively. However, from 6 months postoperatively, the former showed better clinical efficacy. There was no significant difference in the impact on the progression of femoral head collapse between the two intervention methods within the 1-year follow-up period postoperatively. The safety of ICA during the perioperative period has been confirmed. For patients with severe pain or poor quality of life due to early ONFH, IBG+ICA treatment may be a good choice to improve the patient’s pain and quality of life.
Keywords: Icariin, Impacted bone graft, Hip osteonecrosis, Outcomes, Statistical Package for the Social Sciences
References:
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| How to Cite this article: Xu Y, Sun W, Zhou Y, Gao F. Efficacy and safety of Icariin capsules in intervening post-operative bone grafting for hip osteonecrosis in ARCO stage II. Journal of Regenerative Science. July-Decemnber 2025;5(2):13-19. |
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All Roads Lead to Rome
Editorial | Vol 5 | Issue 2 | July-December 2025 | page: 01 | Daniel Moya
DOI: https://doi.org/10.13107/jrs.2025.v05.i02.169
Open Access License: CC BY-NC 4.0
Copyright Statement: Copyright © 2025; The Author(s).
Submitted Date: 29 Jul 2025, Review Date: 25 Aug 2025, Accepted Date: 15 Nov 2025 & Published: 30 Dec 2025
Author: Daniel Moya [1]
[1] Department of Orthopaedics, Hospital Británico de Buenos Aires, Argentina
Address of Correspondence
Dr. Daniel Moya,
Department of Orthopaedics, Hospital Británico de Buenos Aires, Argentina.
E-mail: drdanielmoya@yahoo.com.ar
Editorial
The popular proverbial saying that all roads lead to Rome has a basis in reality. In 20 BC, Emperor Augustus built in the Roman forum a bronze monument covered in Bronze called “Milliarium Aureum,” which marked kilometer zero of the Roman roads. [1] The reference point was considered the origin of some 400 roads that extended for approximately 80,000 km, integrating the extent of the Roman Empire.
The first mention of this phrase is in the Middle Ages, in a text from 1175 that literally reads “Mille viae ducunt hominem per saecula Romam,” which translates to “A thousand roads lead a man to Rome forever.”[2] This road network had administrative, military, and commercial implications, but it also allowed a flow of people from different backgrounds that made the “Eternal City” the capital of the world for many centuries.
Unlike other great imperial capitals, Rome has managed to withstand the ups and downs of history and remain one of the international points of reference from a cultural, political, and economic point of view.
Therefore, it is no coincidence that Rome has been chosen as the venue for the next meeting of the International Federation of Shockwave Therapy.
On May 29th and 30th, 2026, with the organization of the International Federation of Shock Wave Therapy, the Societá Italiana di Terapia con Onde D’Urto and the Accademia di Medicina e Chirurgia Bioregenerativa, an international meeting on shockwave therapy and regenerative medicine will be held at the Ospedale Santo Spirito Monumental Complex. Located steps from the Vatican, the convention center stands in the oldest hospital in Europe, founded in Rome in the 8th century for Saxon pilgrims and rebuilt by Pope Innocent III in the 13th century [3].
The congress will have a very high academic level with the participation of world leaders from all corners of the planet.
Considering the scientific, tourist, and cultural attractions of the proposal, it is clear that by 2026, all roads of shock waves and regenerative medicine lead to Rome.
Information: comunicazione@glowagency.it
References:
1. Mari, Ζ. s.v. “Miliarium Aureum”. Lexicon Topographicum Urbis Romae, vol III. Rome; 1996. pp: 250-51.
2. Martínez MA. All roads lead to Rome (Omnes viae Romam ducunt). Antiquitatem: History of Greece and Rome. November 30, 2015. Available from: https://www.antiquitatem.com/en/all-roads-lead-to-rome/ Last accessed: 20 July 2025
3. The Santo Spirito in Saxia Museum Hub. [updated 2025 Oct 10]
Available from: https://www.santospiritoinsassia.com/en/
Last accessed: 20 July 2025
| How to Cite this article: Moya D. All roads lead to Rome. Journal of Regenerative Science. July-December 2025; 5(2): 01. |
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Exploratory Analysis of Pain and Function Improvement after Radial Pressure Wave Therapy in Plantar Fasciitis
Original Article | Vol 5 | Issue 1 | January-June 2025 | page: 08-13 | Armando Tonatiuh Ávila García, Ana Lilia Villagrana Rodríguez, Cinthia Citlalli Domínguez Navarrete, Karen Chacón Morales, Marco Antonio González López
DOI: https://doi.org/10.13107/jrs.2025.v05.i01.159
Open Access License: CC BY-NC 4.0
Copyright Statement: Copyright © 2025; The Author(s).
Submitted Date: 07 Mar 2025, Review Date: 30 Apr 2025, Accepted Date: 10 May 2025 & Published: 30 Jun 2025
Author: Armando Tonatiuh Ávila García [1], Ana Lilia Villagrana Rodríguez [1], Cinthia Citlalli Domínguez Navarrete [1], Karen Chacón Morales [1], Marco Antonio González López [1]
[1] Department of Physical Medicine and Rehabilitation, Hospital Civil de Guadalajara Fray Antonio Alcalde, Jalisco, México, 44280
Address of Correspondence
Dr. Armando Tonatiuh Ávila García,
Department of Physical Medicine and Rehabilitation, Hospital Civil de Guadalajara Fray Antonio Alcalde, Coronel Calderón 777, Guadalajara, Jalisco, México, 44280
E-mail: atavila@hcg.gob.mx
Abstract
Background: Plantar fasciitis (PF) is a common cause of heel pain, impairing functionality and quality of life. Radial pressure wave therapy (RPWT) is a well-known non-invasive option to treat PF, but evidence on factors influencing outcomes is limited.
Objectives: The objectives of the study are to explore associations between baseline patient characteristics and clinical outcomes and to evaluate the impact of RPWT on pain and functionality in PF patients.
Materials and Methods: This exploratory, pilot study included 19 PF patients treated with three RPWT sessions. Pain intensity (numerical pain rating scale [NPRS]) and functionality (World Health Organization Disability Assessment Schedule 2.0 [WHODAS 2.0]) were assessed pre- and post-treatment. Retrospective data on age, body mass index (BMI), and PF chronicity were analyzed. Statistical tests included Wilcoxon signed rank for outcome comparisons and Spearman’s correlation for associations.
Results: NPRS scores decreased significantly from 6.89 ± 1.88 to 4.42 ± 2.36 (P = 0.001), while WHODAS 2.0 scores improved from 47.60 ± 21.85 to 21.34 ± 20.30 (P = 0.001). Baseline NPRS scores showed a moderate, positive correlation with post-treatment NPRS scores (ρ = 0.561, P = 0.01). No significant correlations were found between post-treatment outcomes and BMI, age, or PF chronicity.
Conclusion: RPWT significantly reduced pain and improved functionality in PF patients, with baseline pain levels emerging as a factor associated with outcomes. These preliminary findings support RPWT as a promising treatment and highlight the need for larger, controlled studies to validate and expand these results.
Keywords: Pain intensity, Plantar fasciitis, Radial pressure wave therapy, Rehabilitation outcomes, Therapeutic effectiveness, Treatment predictors
References:
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20. Lai TW, Ma HL, Lee MS, Chen PM, Ku MC. Ultrasonography and clinical outcome comparison of extracorporeal shock wave therapy and corticosteroid injections for chronic plantar fasciitis: A randomized controlled trial. J Musculoskelet Neuronal Interact 2018;18:47-54.
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| How to Cite this article: Ávila García AT, Rodríguez ALV, Navarrete CCD, Morales KC, López MAG | Exploratory analysis of pain and function improvement after radial pressure wave therapy in plantar fasciitis. | Journal of Regenerative Science | Jan-Jun 2025; 5(1): 08-13. |
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Autologous versus Non-autologous Exosomes: Immunological, Safety, and Regulatory Considerations in Regenerative Medicine
Original Article | Vol 5 | Issue 1 | January-June 2025 | page: 31-33 | Ivanny Marchant, Belén Rodríguez, Valentina Pozo, Leopoldo Parada, Carla Salvo, Pablo Olivero
DOI: https://doi.org/10.13107/jrs.2025.v05.i01.167
Open Access License: CC BY-NC 4.0
Copyright Statement: Copyright © 2025; The Author(s).
Submitted Date: 16 Mar 2025, Review Date: 20 May 2025, Accepted Date: May 2025 & Published: 30 Jun 2025
Author: Ivanny Marchant [1], Belén Rodríguez [1], Valentina Pozo [1], Leopoldo Parada [2], Carla Salvo [3], Pablo Olivero [1]
[1] Unidad de Estudios Clínicos, Escuela de Medicina, Universidad de Valparaíso, Chile,
[2] Centro de Medicina Regenerativa CITOMED, Viña del Mar, Chile,
[3] Centro de Sangre y Tejidos de Valparaíso, Chile.
Address of Correspondence
Dr. Pablo Olivero,
Unidad de Estudios Clínicos, Escuela de Medicina, Universidad de Valparaíso, Chile.
E-mail: pablo.olivero@uv.cl
Abstract
Small extracellular vesicles (sEVs), commonly referred to as exosomes, have emerged as novel therapeutic tools in regenerative and esthetic medicine. A critical decision in their clinical application is the choice between autologous and non-autologous products, as this distinction directly impacts safety, immunocompatibility, efficacy, and regulatory compliance. This review analyzes the immunological profile and biological risks associated with exosomes’ clinical use according to their cellular origin, addressing persistence, pathogen transmission, delivery routes, and regulatory classification. Furthermore, we highlight the strategic role of blood centers and biobanks in producing high-safety allogeneic sEVs, especially those derived from human platelets and mesenchymal stromal cells expanded in xenofree conditions. While autologous exosomes offer maximal immunological safety, standardized allogeneic strategies free from animal-derived components represent a scalable and regulatory-compatible alternative for modern regenerative therapies.
Keywords: Exosomes, Regenerative Medicine, Autologous Exosomes, Non-autologous Exosomes
References:
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8. Andriolo G, Provasi E, Cicero VL, Brambilla A, Soncin S, Torre T, et al. Exosomes from human cardiac progenitor cells for therapeutic applications: Development of a GMP-grade manufacturing method. Front Physiol 2018;9:1169.
9. Codispoti B, Marrelli M, Paduano F, Tatullo M. NANOmetric Bio-banked MSC-derived exosome (NANOBIOME) as a novel approach to regenerative medicine. J Clin Med 2018;7:357.
10. Muthu S, Bapat A, Jain R, Jeyaraman N, Jeyaraman M. Exosomal therapy-a new frontier in regenerative medicine. Stem Cell Investig 2021;8:7.
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12. D’Souza R, Her Y, Hussain N, Karri J, Schatman ME, Calodney AK, et al. Evidence-based clinical practice guidelines on regenerative medicine treatment for chronic pain: A consensus report from a multispecialty working group. J Pain Res 2024;17:2951-3001.
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| How to Cite this article: Marchant I, Rodríguez B, Pozo V, Parada L, Salvo C, Olivero P | Autologous versus Non-autologous Exosomes: Immunological, Safety, and Regulatory Considerations in Regenerative Medicine | Journal of Regenerative Science | Jan-Jun 2025; 5(1): 31-33.
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Assessment of the Efficacy of Extracorporeal Shock Wave Therapy in Adhesive Capsulitis: Outcomes Analysis and Predictors of Recurrence
Original Article | Vol 5 | Issue 1 | January-June 2025 | page: 23-30 | Paul Teran, Anabel Lozada, Francisco Endara, Luis Guzman
DOI: https://doi.org/10.13107/jrs.2025.v05.i01.165
Open Access License: CC BY-NC 4.0
Copyright Statement: Copyright © 2025; The Author(s).
Submitted Date: 26 April 2025, Review Date: 15 May 2025, Accepted Date: May 2025 & Published: 30 Jun 2025
Author: Paul Teran [1, 2], Anabel Lozada [1], Francisco Endara [1], Luis Guzman [3]
[1] Orthopedic Surgeon, Orthopedic Specialties Center (CEO), Quito-Ecuador,
[2] Department of Traumatology and Orthopedics, Metropolitan Hospital, Quito – Ecuador,
[3] Physician, Orthopedic Specialties Center (CEO), Quito-Ecuador.
Address of Correspondence
Dr. Paul Germán Terán Vela,
Orthopaedic Surgeon, Orthopedic Specialties Center (CEO), Quito-Ecuador.
E-mail: paulteranmd@gmail.com
Abstract
Background: Adhesive capsulitis of the shoulder is a condition characterized by pain and progressive restriction of the range of motion. Its management remains a clinical challenge due to variability in therapeutic response. Extracorporeal shock wave therapy (ESWT) has emerged as a non-invasive alternative with potential antifibrotic and analgesic effects. However, evidence regarding its efficacy and the factors associated with recurrence is limited.
Objectives: To assess the effectiveness of ESWT in functional improvement and pain reduction in patients with adhesive capsulitis and to analyze clinical factors associated with recurrence.
Study Design: A retrospective observational study conducted in a cohort of patients with adhesive capsulitis treated with ESWT. The study adhered to strengthening the reporting of observational studies in epidemiology guidelines for observational research.
Materials and Methods: Nineteen patients with a clinical and image-based diagnosis of adhesive capsulitis in the inflammatory or adhesive stage, treated with ESWT at a specialized center, were included. Patients with prior shoulder surgery, inflammatory arthritis, joint infection, or full-thickness rotator cuff tear were excluded. Demographic, clinical, and therapeutic variables were analyzed.
Measured Outcomes:
• Functionality: Disabilities of the arm, shoulder, and hand (DASH) score, pre- and post-treatment
• Pain: Visual analog scale (VAS)
• Recurrence: Reappearance of symptoms requiring additional intervention within a 1-year period.
Multivariable logistic regression with Lasso regularization was used to identify predictors of recurrence.
Outcomes: Following ESWT treatment, there was a significant reduction in DASH scores (62.4 ± 11.2 pre-treatment vs. 35.6 ± 9.8 post-treatment, P < 0.001) and in VAS scores (mean reduction of 3.8 points, P < 0.001). The 1-year recurrence rate was 26.3%. The following clinical factors were associated with an increased risk of recurrence:
• Advanced age (Odds ratio [OR] = 1.08, confidence interval [IC] 95%: 1.01–1.15, P = 0.02)
• Longer duration from symptom onset to the initiation of ESWT (OR = 1.23, IC 95%: 1.06–1.41, P = 0.004)
• Treatment cost as a mild protective factor (OR = 0.92, IC 95%: 0.85–0.99, P = 0.048).
No significant association was found between the number of ESWT sessions and functional improvement (r = 0.12, P = 0.34).
Conclusion: ESWT has demonstrated significant efficacy in improving functional outcomes and reducing pain in patients with adhesive capsulitis. Nevertheless, advanced age and delayed initiation of therapy have been identified as factors associated with an increased risk of recurrence. Early intervention is therefore recommended to optimize therapeutic outcomes. Further prospective studies with larger sample sizes and appropriate control groups are warranted to validate these findings.
Keywords: Adhesive capsulitis, Frozen shoulder, Extracorporeal shock waves, Extracorporeal shock wave therapy, Capsular fibrosis, Rehabilitation, Recurrence factors
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| How to Cite this article: Terán P, Lozada A, Endara F, Guzmán L | Assessment of the efficacy of extracorporeal shock wave therapy in adhesive capsulitis: Outcomes analysis and predictors of recurrence. | Journal of Regenerative Science | Jan-Jun 2025; 5(1): 23-30.
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Proposal of a standardized positioning for rotator cuff treatment with shock waves and radial pressure waves: An anatomo-imaging correlation
Original Article | Vol 5 | Issue 1 | January-June 2025 | page: 19-22 | María Laura Tutté, Marcela Cedrés, Gabriela Stadler, Daniel Moya
DOI: https://doi.org/10.13107/jrs.2025.v05.i01.163
Open Access License: CC BY-NC 4.0
Copyright Statement: Copyright © 2025; The Author(s).
Submitted Date: 2025, Review Date: 2025, Accepted Date: 2025 & Published: 30 Jun 2025
Author: María Laura Tutté [1], Marcela Cedrés [2], Gabriela Stadler [1], Daniel Moya [3]
[1] Department of Rehabilitation and Physical Medicine, State Insurance Bank Hospital Montevideo, Uruguay,
[2] Department of Imagenology, State Insurance Bank Hospital, Montevideo, Uruguay,
[3] Department of Orthopaedic Surgery, Buenos Aires British Hospital, Argentina.
Address of Correspondence
Dr. María Laura Tutté,
Department of Rehabilitation and Physical Medicine, State Insurance Bank Hospital Montevideo, Uruguay.
E-mail: dra.tutte@gmail.com
Abstract
One of the keys to successful treatment with radial pressure waves and focused shock waves is being able to deliver the energy to the right area. The shoulder region is characterized by a complex architecture with overlapping structures, which can make it difficult to locate the area to be treated.
The aim of this study is to describe the best upper limb positions and standardized approaches to treat rotator cuff pathology, based on the correlation of radiological and ultrasound images obtained during a joint examination by an imaging expert and a shock wave specialist.
Keywords: Extracorporeal shock wave therapy, Radial pressure waves, Arm positioning, Shoulder ultrasound
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| How to Cite this article: Tutté ML, Cedrés M, Stadler G, Moya D | Proposal of a standardized positioning for rotator cuff treatment with shock waves and radial pressure waves: An anatomoimaging correlation. | Journal of Regenerative Science | Jan-Jun 2025; 5(1): 19-22.
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