Critical Limb Ischemia Clinical Trial
Official title:
Recombinant SeV-hFGF2 / dF Injection (BF30) Single-dose Therapy in Patients With Peripheral Arterial Occlusive Disease, a Dose Escalation, Safety, Tolerability Phase I Clinical Trial
Lower extremity arteriosclerosis obliterans is due to the formation of atherosclerotic plaque
in the lower extremities, resulting in the stenosis and occlusion of the artery, leading to
chronic ischemia of the limbs. Although bypass surgery and angioplasty ( or interventional
therapy ) are effective methods for vascular treatment in patients with PAD to revascularize,
a significant proportion of patients with the arterial disease are not eligible for direct
arterial surgery. Meanwhile, there are many patients who suffer from diffuse arterial disease
or severe peripheral disease not suitable for interventional therapy. Stimulation of
arteriogenesis( blood bypassing the occluded arteries through a large number of collateral
vessels ) and angiogenesis ( generating new small blood vessels ) have become the focus of
research.
Our recombinant SeV-hFGF2/dF injection (R&D code BF30 ) uses the human basic fibroblast
growth factor ( FGF2 ) gene to express the target protein FGF2 locally by intramuscular
injection. The preparation can efficiently express FGF2 in infected cells and secrete it to
the periphery and be fixed in the intercellular substance. Since FGF2 is in the upstream
regulatory pathway of VEGF, HGF and other factors, it can regulate the coordinated expression
of these cytokines related to the growth and function of new blood vessels, and finally,
produce mature blood vessels.
To evaluate the safety ( tolerance), pharmacokinetics (PK), biological activity, and
immunogenicity of BF30 in patients with lower extremity arterial occlusive disease, and to
explore clinical benefits.
MAIN OBJECTIVE: To evaluate the safety ( tolerability ) of single-dose BF30 in patients with
lower extremity arterial occlusive disease, and to provide evidence for the dose of
subsequent clinical trials.
Secondary objective: To explore the pharmacokinetics (PK), biological activity, the
immunogenicity of BF30, and to initially explore clinical benefits.
n/a
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