Use of VEGF for wound healing
A technique for wound healing and wound healing, applied in the field of use of vascular endothelial growth factor for wound healing, which can solve the problems of disappointing efficacy and cost
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[0023] VEGF variants are prepared optionally by site-directed mutagenesis of nucleotides in DNA encoding native VEGF or by phage display techniques, whereby DNA encoding the variant is generated and then expressed in recombinant cell culture.
[0024] Although the sites for introducing amino acid sequence variations are predetermined, the mutations themselves need not be predetermined. For example, to optimize the consequences of a mutation at a given site, random mutagenesis can be performed at a codon or region of interest and the expressed VEGF variants screened for the best combination of desired activities. Techniques for substitutional mutagenesis at predetermined sites in DNA of known sequence are well known, such as, for example, site-specific mutagenesis. Production of VEGF variants described herein can be accomplished by phage display techniques, such as those described in PCT publication WO 00 / 63380.
[0025] After such a clone is selected, the mutated protein regi...
Embodiment 1
[0179] Example 1: Surface VEGF in Wound Healing VGF2763g Clinical Trial
[0180] A double-blind (eg, pharmacist-informed, physician-informed, and patient-informed) clinical trial was conducted to determine whether topical application of VEGF improves wound healing in human subjects with diabetic ulcers. Table 4 is a graph of the baseline disease characteristics of patients in a study administering rhVEGF (referred to herein as "Telbermin") to treat diabetic wounds. The study design is shown in Figure 1.
[0181] Table 4 Baseline condition
[0182] Placebo (N=26)
Telbermin (N=29)
Average age, years (range)
59.3(38-81)
59.5(42-74)
Mean glucose, mg / dL (range) *
225.8(77-465)
179.1(29-593)
Average HbA1C, %(range)
8.4(5.5-13.6)
8.3(5.6-13.6)
Ulcers debrided at screening, N (%)
yes
no
21(80.8)
5(19.2)
27(93.1)
2(6.9)
Average ulcer area, cm 2 (scope)...
Embodiment 2
[0208] Example 2: Surface VEGF in wound healing
[0209] Estimated ulcer area (eg, ≥1.0 cm) after sharp debridement at the start of treatment 2 And ≤6.5cm 2 Subjects, such as patients with type 1 or type 2 diabetes, are treated with topical recombinant VEGF (e.g., gel formulation) daily for 12 weeks (up to 84 doses in total) or until the wound is completely closed (e.g., no drainage or skin closure required for wrapping), whichever comes first. Subjects may be observed for 12 weeks or more after the treatment period. Subjects received 24 μg / cm each in a once-daily treatment 2 , 72μg / cm 2 or 216μg / cm 2 VEGF. Estimated ulcer surface area (cm 2 ), eg length (L (cm)) is measured from the longest edge to edge of the ulcer and width (W (cm)) is measured from the longest edge to edge of the axis perpendicular to the length. Then estimate the surface area as LxW. Effects of treatment can be assessed by measurement of the circumference of the ulcerated area via tracings, plani...
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