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An exploratory clinical trial for concentrated autologous bone marrow aspirate transplantation in the treatment of osteonecrosis of the femoral head

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European Journal of Orthopaedic Surgery & Traumatology Aims and scope Submit manuscript

Abstract

Purpose

This study evaluated the efficacy and safety of a novel treatment for osteonecrosis, in which concentrated autologous bone marrow aspirate transplantation (CABMAT) is followed by low-intensity pulsed ultrasound (LIPUS) stimulation for 3 months. The study was designed as a prospective, uncontrolled, open-label phase II clinical study.

Methods

This study included 16 cases of osteonecrosis of the femoral head (ONFH), including 26 hips. Patients were transplanted with concentrated bone marrow and periodically evaluated for infection and neoplasm development. Moreover, clinical and radiological examinations were conducted to confirm the treatment efficacy.

Results

No infections were observed during the course of this study nor tumours developed at the treatment site 24 months after transplantation. At a mean 48 (30–56) months post-transplantation, the onset or progression of collapse was noted in four hips, of which one hip underwent total hip arthroplasty.

Conclusion

Treatment with CABMAT combined with 3-month LIPUS stimulation was safe, and further randomised clinical studies are needed to determine the efficacy and feasibility of this treatment.

Trial registration

UMIN Clinical Trials Registry (UMIN000020940, 9/2/2016).

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Acknowledgements

The authors thank Hiroshi Akaogi (Department of Orthopaedic Surgery, Faculty of Medicine, University of Tsukuba) for  technical assistance regarding the design of figure and Chizuko Fujisawa (Laboratory of Regenerative Medicine and Stem Cell Biology, Graduate School of Comprehensive Human Sciences, University of Tsukuba) for technical assistance regarding the characterization of cells.

Funding

No funding was received to assist with the preparation of this manuscript.

Author information

Authors and Affiliations

  1. Department of Health, Faculty of Health Sciences, Tsukuba University of Technology, Tsukuba, Japan

    Hisashi Sugaya

  2. Department of Orthopaedic Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan

    Hisashi Sugaya, Tomokazu Yoshioka, Yohei Tomaru, Hiroshi Kumagai, Masashi Yamazaki & Hajime Mishima

  3. Division of Regenerative Medicine for Musculoskeletal System, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan

    Tomokazu Yoshioka

Authors
  1. Hisashi Sugaya
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  2. Tomokazu Yoshioka
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  4. Hiroshi Kumagai
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  5. Masashi Yamazaki
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  6. Hajime Mishima
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Contributions

All authors contributed to the study conception and design. Data collection and analysis, surgeries, and evaluation of femoral head collapse were performed by Hisashi Sugaya and Tomokazu Yoshioka. Data analysis and evaluation of femoral head collapse were also performed by Yohei Tomaru and Hiroshi Kumagai. Procedures and post-operative evaluations were performed by Hajime Mishima. Supervision of the research project was performed by Masashi Yamazaki and Hajime Mishima. The first draft of the manuscript was written by Hisashi Sugaya, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript. Hisashi Sugaya and Tomokazu Yoshioka contributed equally to this work.

Corresponding author

Correspondence to Hisashi Sugaya.

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Conflict of interest

The authors have no conflicts of interest to declare that are relevant to the content of this article.

Availability of data and material

The data that support the findings of this study are available from the corresponding author, Hisashi Sugaya, upon reasonable request.

Ethics approval

Approval was obtained from the ethics committee of the University of Tsukuba Hospital. The procedures performed in this study adhered to the tenets of the Declaration of Helsinki.

Consent to participate

Informed consent was obtained from all individual participants included in the study.

Consent for publication

Patients signed informed consent regarding publishing their data.

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Sugaya, H., Yoshioka, T., Tomaru, Y. et al. An exploratory clinical trial for concentrated autologous bone marrow aspirate transplantation in the treatment of osteonecrosis of the femoral head. Eur J Orthop Surg Traumatol 33, 441–447 (2023). https://doi.org/10.1007/s00590-022-03201-6

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  • DOI: https://doi.org/10.1007/s00590-022-03201-6

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