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.
Tantuway V., Jeyaraman M., Nallakumarasamy A., Prikh MB., Sharma AK., Sharma R.
Prospective Study with a reported sample of 10 on Hip, published in Indian J Orthop (2023) — summary generated from the PubMed abstract.
Early human evidence such as case series or small samples is exploring possible benefits.
- Level A · Stronger Clinical Evidence
- Level B · Emerging clinical evidence with positive signals
- Level C · Early human research exploring benefits
- Level D · Scientific groundwork from lab and animal studies
- Emerging · Emerging topic under active research
This page is generated from the PubMed record. The Thai description is an automated summary of bibliographic fields and the abstract, not a full translation, and is not medical advice.
- Study type
- Prospective Study
- Journal
- Indian J Orthop (2023)
- Country
- Switzerland
- Reported sample size
- 10
- Source database
- PubMed
- PMID
- 38161400
- PMCID
- PMC10754810
- DOI
- 10.1007/s43465-023-01041-y
- Citations
- 5
Abstract (original English)
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). 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 × 10 7 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. 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. For individuals
What this study does not prove
- • This study does not prove SVF is an approved treatment or a replacement for standard care.
Evidence level
Early human evidence such as case series or small samples is exploring possible benefits.
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