TABLE 2.
Preclinical studies using Dextran and/or Pullulan scaffold in ectopic sites.
| Author (Year) | Animal model (sex; species); n, number of animals used | Implantation site, dimension of the implanted material | Conditions (N, number of total implanted materials per condition) | Observation time [in day (D), week (W) or month (M)] | Experimental analysis | Results |
|---|---|---|---|---|---|---|
| Maire et al. (2005b) | Rat (male, Sprague Dawley), n = 21 | Muscle implantation (back) | 1: BMP (N = 20) | 7 W | 2D X-ray (qualitative analysis) | Dextran (DS 18%) + BMP showed large radiopaque areas compared to other groups (no statistical significance due to heterogeneity within the same group) |
| 2: Dextran (DS 0%) + BMP (N = 14) | ||||||
| Collagen sponge Diameter: 7 mm Height: 7 mm | 3: Dextran (DS 2%) + BMP (N = 14) | Stevenel blue and Van Gieson Picrofuschin staining (Bone formation); Von Kossa staining (qualitative analysis) | For Dextran (DS 18%) + BMP group, bone formation occurred through endochondral ossification or by intramembranous ossification | |||
| 4: Dextran (DS 18%) + BMP (N = 14) | ||||||
| Degat et al. (2007) | Rat (male, Sprague Dawley), n = 24 | Subcutaneous (back) | 1: BMP-2 (N = 6) | 4 W | Calcium mass (µg/implant) | Dextran (10 µg) + BMP-2 ** > BMP-2 |
| 2: Dextran (1 µg) + BMP-2 (N = 6) | ||||||
| Collagen sponge | 3: Dextran (10 µg) + BMP-2 (N = 6) | BMP-2 * > Dextran (100 µg) + BMP-2 | ||||
| Diameter: 3 mm Height: 2 mm | 4: Dextran (100 µg) + BMP-2 (N = 6) | |||||
| Chen et al. (2019) | Mouse (male, C57BL/6), n = 3 | Muscle implantation (leg) | 1: BMP-2 (N=NS) | 2 W | Wet and ash weights of ectopic bone (g) | No significant difference observed between Dextran + BMP-2 and BMP-2 alone groups |
| Gelatin sponge size | 2: Chitosan + BMP-2 (N=NS) | |||||
| Length: 0.5 cm | 3: Dextran + BMP-2 (N=NS) | |||||
| Width: 0.5 cm | 4: PSS + BMP-2 (N=NS) | 4 W | Masson’s Trichrome staining (qualitative analysis) | Dextran + BMP-2 less bone formation compared to other groups | ||
| Height: 0.3 cm | ||||||
| Yu et al. (2020) | Mouse (male, C56BL/6), n = 40 | Muscle implantation (leg) | 1: BMP-2 (10 µg) (N = 16) | 2 W | Micro-CT (BVF in %) | No significant difference between groups |
| 2: BMP-2 (15 µg) (N = 16) | ||||||
| Gelatin sponge size: NS | 3: Heparin + BMP-2 (N = 16) | |||||
| 4: Chitosan + BMP-2 (N = 16) | 4 W | Masson’s Trichrome staining; TRAP+ staining (qualitative analysis) | At 4W: for Dextran + BMP-2 group, traces of trabecular bone and bone resorption occurred | |||
| 5: Dextran + BMP-2 (N = 16) | ||||||
| Hayashi et al. (2009) | Mouse (male, ICR), n = NS | Muscle implantation (leg) | 1: Pullulan (N = 3–4) | 3 W | Micro-CT (BV in mm3) | No significant difference between Pullulan and Pullulan + BMP-2 group |
| Diameter: 2.5 mm | 2: Pullulan + BMP-2 (2 µg) (N = 3–4) | |||||
| Height: NS | ||||||
| Fricain et al. (2013) | Mouse (NS, Balb/c), n = NS | Subcutaneous (back) | 1: Pullulan/Dextran (N = 6) | 15 D | Micro-CT (MC in mg; MD in mg/cm3) | Pullulan/Dextran + HA ** > Pullulan/Dextran |
| Diameter: 4 mm | 2: Pullulan/Dextran + HA (N = 6) | 30 D | ||||
| Height: 4 mm | 60 D | Enzyme Immunoassay for BMP-2 (pg/mg protein) | Pullulan/Dextran + HA * > Pullulan/Dextran | |||
| Goat (NS) n = 7 | Muscle implantation (back) | 1: Pullulan/Dextran (N = 12) | 1 M | Micro-CT (qualitative analysis) | Osteoid tissue formation for Pullulan/Dextran + HA group | |
| Diameter: 10 mm | 2: Pullulan/Dextran + HA (N = 12) | 6 M | Von Kossa staining; Masson’s Trichrome staining (qualitative analysis) | Osteoid tissue formation for Pullulan/Dextran + HA group | ||
| Depth: 10 mm |
BMP, bone morphogenetic protein; BV, bone volume; BVF, bone volume fraction; D.S., degree of substitution; HA, hydroxyapatite; MC, mineral content; MD, mineral density; NS, not specified; PSS, poly (sodium-p-styrenesulfonate); * p < 0.05; ** p < 0.01.