Combination ex vivo regional gene therapy with sonic hedgehog and bone morphogenetic protein-2 does not enhance bone healing in critical size defects.
Mayfield CK., Wier J., Ball JR., Gallo MC., Hernandez F., Shelby T.
Randomized Controlled Trial, published in Connect Tissue Res (2026) — summary generated from the PubMed abstract.
Several human studies show positive signals, while research methods and sample sizes continue to develop.
- 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
- Randomized Controlled Trial
- Journal
- Connect Tissue Res (2026)
- Country
- England
- Reported sample size
- —
- Source database
- PubMed
- PMID
- 42438194
- DOI
- 10.1080/03008207.2026.2697221
Abstract (original English)
Purpose Large bone defects pose significant challenges for orthopedic surgeons. Regional gene therapy using adipose-derived stem cells (ADSCs) transduced with a lentiviral vector to express bone morphogenetic protein 2 (LV-BMP-2) has shown promise in preclinical models. Recent studies suggest sonic hedgehog (SHH)-mediated signaling may act synergistically with BMP-2 to enhance osteogenesis. This study evaluated whether combination gene therapy with rat ADSCs transduced with LV-BMP-2 and LV-SHH could heal rat critical size femoral defects. Materials/methods Seventy-one rats were randomly assigned to seven groups including four experimental groups, one positive control, and two negative controls. A two-step transcription amplification (TSTA) lentiviral vector was used to transduce BMP-2 and/or SHH into ADSCs. A 6 mm critical-sized femoral defect was created in Lewis rats and experimental groups received transduced cells. Biomechanical, imaging, and histomorphometric analysis was conducted to evaluate bone healing outcomes. Results No significant difference in mean stiffness, total energy to failure, or maximum torque was observed between rats receiving 3 M LV-BMP-2 versus those receiving combination therapy of 3 M or 5 M LV-BMP-2 + LV-SHH therapy, however all had superior healing compared to negative controls. Similar results were observed for imaging and histomorphometric outcom
What this study does not prove
- • This study does not prove SVF is an approved treatment or a replacement for standard care.
Evidence level
Several human studies show positive signals, while research methods and sample sizes continue to develop.
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