Safety and Efficacy Study of Gene Therapy Drug (Neovasculgen) to Treat Secondary Raynaud's Phenom… (NCT02356809) | Clinical Trial Compass
UnknownPhase 1/2
Safety and Efficacy Study of Gene Therapy Drug (Neovasculgen) to Treat Secondary Raynaud's Phenomenon
Russia30 participantsStarted 2015-03
Plain-language summary
The purpose of this study is to determine whether pl-vegf165 (Neovasculgen) is effective in the treatment of digital ulcers related to secondary Raynaud's phenomenon associated with systemic scleroderma
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* obtained voluntary informed consent for participation in the clinical study
* presence of systemic scleroderma features satisfied to criteria of American College of Rheumatology classification
* presence at least one active digital ulcer at baseline
Exclusion Criteria:
* presence of another systemic connective tissue disease;
* absence at least one active digital ulcer at baseline;
* smoking within 3 months or smoking cessation using nicotine products;
* subjects currently taking sildenafil, tadalafil or vardenafil;
* history of sympathectomy over previous 12 months
* not able or unwilling to give voluntary informed consent for the study or follow requirements of the clinical study;
* decompensated chronic visceral diseases;
* clinically significant laboratory abnormalities;
* HIV, HBV and HCV antibodies in serum;
* alcohol or drug addiction;
* participation in other clinical studies (or administration of study products) within 3 months prior the study;
* conditions limiting study compliance (dementia, psycho-neurological diseases, drug addiction, alcoholism, etc.);
* malignancies including post-surgical period with chemo- and (or) radiation therapy);
* vascular malformations;
* pregnancy or breastfeeding.