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

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

March 31, 2015

Study Completion Date

August 31, 2015

Conditions
Secondary Raynaud's Phenomenon
Interventions
DRUG

Neovasculgen

Neovasculgen is an original gene construction that contains supercoiled plasmid DNA (1.2 mg) that encodes pCMV-vegf165 as the active substance. The drug will be supplied to the study centre as a sterile lyophilisate that will be then dissolved in 2 ml of water for injections immediately prior to administration. The drug will be administered intramuscularly (interosseous muscles of hand) at 4-5 injection sites in the dorsal surface of the hand.

Trial Locations (1)

Unknown

Human Stem Cell Institute, Moscow

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Russian Academy of Medical Sciences

OTHER

lead

Artgen Biotech

OTHER

NCT02356809 - Safety and Efficacy Study of Gene Therapy Drug (Neovasculgen) to Treat Secondary Raynaud's Phenomenon | Biotech Hunter | Biotech Hunter