Peripheral Nerve Injury Clinical Trial
Official title:
Enhancement of Functional Recovery After Peripheral Nerve Injury With Tacrolimus
Tacrolimus (FK506) is an immunosuppressive medication that promotes organ allograft survival.
It has also been shown to enhance nerve regeneration and muscle reinnervation in animals but
these properties have not previously been studied in patients. Moreover, currently there is
no method in clinical use to speed the rate of recovery after nerve injury. The objective of
this study is to explore the ability of tacrolimus to benefit the treatment of patients with
peripheral nerve injury. To minimize the morbidity of tacrolimus therapy, its phase-specific
effects on nerve regeneration and muscle reinnervation will be defined in the murine model to
permit further limitation of the duration of therapy. The investigators hypothesize that
treatment with tacrolimus after autogenous peripheral nerve reconstruction will accelerate
nerve regeneration, reduce the period of denervation and improve muscle reinnervation and
recovery in patients with peripheral nerve injury.
There are 2 specific aims:
1. Determine the safety and efficacy of tacrolimus following reconstructive nerve surgery
in a double-blind placebo-controlled randomized pilot clinical trial of patients with
severe nerve injuries of the extremities;
2. Correlate the quality of life outcome with assessment of functional recovery after
surgical reconstruction of patients with severe peripheral nerve injuries of the
extremities.
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