Local application of recombinant human fibroblast growth factor-2 on bone repair: A dose-escalation prospective trial on patients with osteotomy

Based on preclinical evidence in animal models, the present study examined the clinical efficacy and safety of recombinant human fibroblast growth factor‐2 (rhFGF‐2) to accelerate bone repair in a dose‐escalation prospective trial. One of three dosages (200, 400 or 800 µg) of rhFGF‐2 in a biodegrada...

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Published in:Journal of orthopaedic research 2007-04, Vol.25 (4), p.480-487
Main Authors: Kawaguchi, Hiroshi, Jingushi, Seiya, Izumi, Toshihiro, Fukunaga, Masao, Matsushita, Takashi, Nakamura, Takashi, Mizuno, Kosaku, Nakamura, Toshitaka, Nakamura, Kozo
Format: Article
Language:English
Subjects:
Adult
Aged
bone
Bone Regeneration - drug effects
Bone Regeneration - physiology
Dose-Response Relationship, Drug
Female
fibroblast growth factor
Fibroblast Growth Factor 2 - adverse effects
Fibroblast Growth Factor 2 - therapeutic use
fracture
human
Humans
Hydrogel, Polyethylene Glycol Dimethacrylate
Male
Middle Aged
Osteoarthritis, Knee - surgery
Osteogenesis - drug effects
Osteogenesis - physiology
Osteotomy - methods
Prospective Studies
Radiography
Recombinant Proteins - adverse effects
Recombinant Proteins - therapeutic use
Tibia - diagnostic imaging
Tibia - physiology
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Summary:Based on preclinical evidence in animal models, the present study examined the clinical efficacy and safety of recombinant human fibroblast growth factor‐2 (rhFGF‐2) to accelerate bone repair in a dose‐escalation prospective trial. One of three dosages (200, 400 or 800 µg) of rhFGF‐2 in a biodegradable gelatin hydrogel was injected during surgery into the osteotomy site of 59 knee osteoarthritis patients undergoing high tibial osteotomy, and 57 of them were monitored for 16 weeks. The rhFGF‐2 dose dependently increased the percentage of patients with radiographic bone union, and decreased the average time needed for such union. The percentages of patients with an absence of pain and full‐weight bearing were also greater in the higher dosage groups than in the low dosage group, especially in the clinically critical periods 6, 8, and 10 weeks. Neither blood chemistries nor clinical adverse events were associated with the rhFGF‐2 dosages. We therefore conclude that the rhFGF‐2 in gelatin hydrogel dose dependently accelerated radiographic bone union of a surgical osteotomy with a safety profile at least at the dosages used, suggesting the clinical efficacy of this agent for bone repair. © 2007 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 25:480–487, 2007
ISSN:0736-0266
1554-527X
DOI:10.1002/jor.20315