Diabetic peripheral neuropathy (DPN) is common pain syndrome and a particularly debilitating complication of diabetes. There are no approved drugs or strategies known to halt or reverse the progression of DPN. Hepatocyte growth factor (HGF) has been shown to be a potent growth factor, stimulating the growth of endothelial cells and movement of vascular smooth muscle cells. The objective of this study is to evaluate the safety and efficacy of IM administration of HGF in subjects with painful DPN in lower extremities.
Am I eligible?
1. Age ≥ 18 years to ≤ 75 years;
2. Documented history of Type I or II diabetes with current treatment control and currently on oral medication and / or insulin;
3. No significant changes anticipated in diabetes medication regimen;
4. No new symptoms associated with diabetes within the last 3 months prior to study entry;
5. Diagnosis of painful diabetic peripheral neuropathy in both lower extremities;
6. Lower extremity pain for at least 6 months
1. Peripheral neuropathy caused by condition other than diabetes;
2. Other pain more severe than neuropathic pain that would prevent assessment of DPN;
3. Progressive or degenerative neurological disorder;
5. Inflammatory disorder of the blood vessels
6. Active infection;
7. Chronic inflammatory disease (e.g., Crohn's disease, rheumatoid arthritis);
8. Positive HIV or HTLV
9. Active Hepatitis B or C
10. Subjects with known immunosuppression or currently receiving immunosuppressive drugs, chemotherapy or radiation therapy;
11. Stroke or myocardial infarction within last 3 months;
12. Ophthalmologic conditions pertinent to proliferative retinopathy or conditions that preclude standard ophthalmologic examination;
13. Uncontrolled hypertension
14. Subjects with a recent history (< 5 years) of or new screening finding of malignant neoplasm
15. Use of PROHIBITED medications.
16. Major psychiatric disorder within last 6 months that would interfere
What is involved?
All subjects will receive sixteen (16) 0.5 mL injections of VM202 or placebo evenly distributed over each calf at each visit.
Screening visits plus 10 additional clinic visits over a year period. Injections on 4 of those visits.