Controlled-release basic fibroblast growth factor for peripheral artery disease: comparison with autologous bone...

Area of Science:

• Regenerative Medicine
• Vascular Biology
• Biomaterials Science

Background:

• Developed a biodegradable hydrogel for controlled, slow-release drug delivery.
• Incorporated basic fibroblast growth factor (b-FGF) into the hydrogel system.

Purpose of the Study:

• To evaluate the safety and efficacy of controlled-release b-FGF in patients with peripheral artery disease (PAD).
• To compare b-FGF therapy with autologous bone marrow mononuclear cell implantation (BMCI) for PAD treatment.

Main Methods:

• Patients with PAD were randomized into two groups: b-FGF (n=10) and BMCI (n=15).
• Treatments involved injection of b-FGF-loaded hydrogel or BMCI.
• Evaluated outcomes included Visual Analog Pain Scale (VAS), Tc-TF scintigraphy, TcPO(2), ABI, and 2-year prognosis.

Main Results:

• Both b-FGF and BMCI significantly improved VAS scores and TcPO(2) levels (p<0.01).
• No significant changes were observed in Tc-TF scintigraphy or ABI between groups.
• Two-year prognosis was similar, with 91% for b-FGF and 80% for BMCI.

Conclusions:

• Controlled-release b-FGF demonstrated comparable safety and efficacy to BMCI for PAD.
• b-FGF therapy presents a viable alternative treatment option for peripheral artery disease.