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Improvement in Chronic Ischemic Neuropathy After Intramuscular phVEGF165 Gene Transfer in Patients With Critical Limb Ischemia
Drasko Simovic, MD;
Jeffrey M. Isner, MD;
Allan H. Ropper, MD;
Ann Pieczek, RN;
David H. Weinberg, MD
Arch Neurol. 2001;58:761-768.
Objective To investigate the effects of vascular endothelial growth factor gene
therapy on ischemic neuropathy in patients with critical limb ischemia.
Design An open-label, dose-escalating trial. Patients with angiographically
proven critical leg ischemia received injections of phVEGF165 human
plasmid in the muscles of the ischemic limb. Testing before treatment and
at 3 and 6 months included (1) symptom severity score, (2) clinical examination
score, and (3) electrophysiologic studies. Clinical and electrophysiologic
examiners were masked to each other's findings.
Setting A tertiary care referral hospital and a major teaching affiliate of
Tufts University School of Medicine, Boston, Mass.
Results Of 29 consecutive patients enrolled, 17 (19 limbs) completed the 6 months
of study. Six patients had diabetes. Compared with baseline studies, treated
patients had significant clinical improvements in the symptom score (P<.01), sensory examination score (P<.01), total examination score (P = .01),
peroneal motor amplitude (P = .03), and quantitative
vibration threshold (P = .04). Improvement in the
vascular ankle-brachial index in treated legs (P<.01)
corresponded to improvement in neuropathy in the same limb. Neurologic improvement
was seen in 4 of 6 patients with diabetes who completed the study. No clinical,
electrophysiologic, or vascular improvements were observed in untreated legs.
Conclusions Ischemic neuropathy might be a reversible condition, and therapeutic
angiogenesis might be an effective treatment. The presence of diabetes does
not preclude a response to this therapy.
From the Division of Neurology (Drs Simovic, Ropper, and Weinberg)
and the Department of Medicine (Cardiology) (Dr Isner and Ms Pieczek), St
Elizabeth's Medical Center, Tufts University School of Medicine, Boston, Mass.
Corresponding author and reprints: David H. Weinberg, MD, St Elizabeth's
Medical Center, 736 Cambridge St, Boston, MA 02135.
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