Gene therapy for diabetic neuropathy using an HGF isoform
The present invention relates to a pharmaceutical composition for the prevention or treatment of diabetic neuropathy, wherein the pharmaceutical composition comprises, as active ingredients, different types of isoforms of HGF or a polynucleotide encoding the isoforms. The present invention is the first invention demonstrating that diabetic neuropathy can be prevented and treated using different types of isoforms of HGF. According to the present invention, it is possible to very effectively treat diabetic neuropathy.
1. A method for treating pain in a human subject having diabetic peripheral neuropathy, the method comprising:
intramuscularly administering to a calf of the human subject in need thereof a pCK-HGF-X7 DNA construct at a dose of 8 mg per affected limb, equally divided into a plurality of injections and plurality of visits to reduce pain in said human subject,
wherein each of the plurality of injections in any single visit is performed at a separate injection site,
wherein the pCK-HGF-X7 DNA construct comprises
the nucleotide sequence as set forth in SEQ ID NO: 13, and
wherein each of the plurality of injections is performed with 0.25 mg of the pCK-HGF-X7 DNA construct in a volume of 0.5 ml.
2. The method of claim 1 , wherein the DNA construct is administered at a dose of 16 mg equally divided into 64 injections,
wherein 16 injections are administered to separate injection sites on a first calf on a first visit,
wherein 16 injections are administered to separate injection sites on a second calf on the first visit,
wherein 16 injections are administered to separate injection sites on the first calf on a second visit, and
wherein 16 injections are administered to separate injection sites on the second calf on the second visit.
3. The method of claim 2 , further comprising repeating the step of intramuscularly administering a 16 mg dose in a subsequent plurality of visits.