Functional Outcome Analysis of Autologous Stromal Vascular Fraction (SVF) (Sahaj Therapy®) Using Direct Sonication in Osteonecrosis of the Femoral Head (ONFH): A 6-Year Follow-Up Study

Vinay Tantuway; Madhan Jeyaraman; Arulkumar Nallakumarasamy; Mittal B Prikh; Aashish K Sharma; Raj Sharma

doi:10.1007/s43465-023-01041-y

Functional Outcome Analysis of Autologous Stromal Vascular Fraction (SVF) (Sahaj Therapy^®) Using Direct Sonication in Osteonecrosis of the Femoral Head (ONFH): A 6-Year Follow-Up Study

Indian J Orthop. 2023 Nov 21;58(1):68-78. doi: 10.1007/s43465-023-01041-y. eCollection 2024 Jan.

Authors

Vinay Tantuway^{1

2}, Madhan Jeyaraman^{2

3

4

5}, Arulkumar Nallakumarasamy³, Mittal B Prikh⁶, Aashish K Sharma⁷, Raj Sharma²

Affiliations

¹ Department of Orthopaedics and Traumatology, Index Medical College Hospital and Research Centre, Indore, Madhya Pradesh India.
² Sahaj Regenerative Cell Therapeutics, Indore, Madhya Pradesh India.
³ Department of Orthopaedics, ACS Medical College and Hospital, Dr MGR Educational and Research Institute, Chennai, Tamil Nadu India.
⁴ Department of Biotechnology, School of Engineering and Technology, Sharda University, Greater Noida, Uttar Pradesh India.
⁵ South Texas Orthopaedic Research Institute (STORI Inc.), Laredo, TX USA.
⁶ Department of Orthopaedics, Navjivan Hospital, Ahmedabad, Gujarat India.
⁷ Department of Orthopaedics and Joint Replacement, CK Birla Hospitals, Jaipur, Rajasthan India.

PMID: 38161400
PMCID: PMC10754810 (available on 2024-11-21)
DOI: 10.1007/s43465-023-01041-y

Abstract

Introduction: We investigated the safety, efficacy, functional, and clinical outcomes of intra-osseous implantation of mechanically isolated, autologous stromal vascular fraction (SVF), an Australian patented direct ultrasonication technology (Sahaj Therapy^®) in osteonecrosis of the femoral head (ONFH).

Materials and methods: A total of 32 cases of ONFH were enrolled in the study after confirming with an MRI of the affected hip. All cases were treated with an intra-osseous autologous SVF implantation [4-5 cc with the cellular dosage of 8.0 × 10⁷ cells with a viability of > 85% SVF cells] on the same surgical sitting. All the cases were followed up clinically, functionally, and radiologically at regular intervals. A comparison of mean HOOS scores at different follow-ups was done using Paired 't'-test. A P value of < 0.05 was considered significant.

Results: In our study, male preponderance was seen (53.1%). According to the modified Ficat and Arlet classification, the most common grade of ONFH was grade 2 [right: 25 hips and left: 25 hips]. There was a statistically significant improvement in the mean HOOS score of the right hip (n = 10) and left hip (n = 9) from preoperative time till 72 months (P < 0.05). The follow-up MRI of the affected hips shows improved osteogenesis without any further worsening of the contour of the femoral head. No adverse effects were seen in any of the study participants.

Conclusion: For individuals with ONFH, treated with intra-osseous autologous SVF implantation in the same surgical procedure is an innovative and promising treatment modality. Even after 6 years of follow-up, the study participants with ONFH have shown good clinical and functional outcomes with autologous SVF.

Keywords: Adipose tissue; Femoral head; Osteonecrosis; Stromal vascular fraction.

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