Safety and Efficacy Study of Gene Therapy Drug (Neovasculgen) to Treat Secondary Raynaud's Phenomenon

• Status: Unknown status
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Human Stem Cell Institute, Russia
• Collaborator: Russian Academy of Medical Sciences

Criteria

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.