Objective: We examined the safety and efficacy of controlled-release basic fibroblast growth factor (b-FGF) for peripheral artery disease (PAD), compared with autologous bone marrow mononuclear cell implantation (BMCI).
Background: We recently developed a b-FGF-incorporated biodegradable hydrogel that enables slow-releasing drug delivery system.
Methods: PAD patients were divided into a b-FGF group (n = 10) and BMCI group (n = 15). Injection of gelatin hydrogel containing 600 mu g b-FGF or BMCI (0.4-5.1 x 10(10) cell) was performed. Visual analog pain scale (VAS), (99m)technetium-tetrofosmin (Tc-TF) scintigraphy, transcutaneous oxygen tension (TcPO(2)), and ankle-brachial index (ABI) were evaluated before and 4 weeks after each treatment, and 2-year prognosis was determined.
Results: VAS (b-FGF 67 +/- 15 to 4 +/- 5, p < 0.01, BMCI 67 +/- 42 to 5 +/- 9mm, p < 0.01) and TcPO(2) (b-FGF 16 +/- 14 to 47 +/- 17, p < 0.01, BMCI 13 +/- 13 to 37 -21mmHg, p < 0.01) were significantly improved in both groups. Tc-TF and ABI were not changed. Prognosis was similar between the groups (b-FGF 91%, BMCI 80%, NS).
Conclusion: Controlled-release b-FGF is as safe as BMCI, and its efficacy appears to be comparable. Thus, this therapy may be an alternative to BMCI.