Date: 2013-04-04
Type of information: Recruitment of the first patient
phase: 2
Announcement: recruitment of the first patients
Company: Shire (UK)
Product: SRM003 - Vascugel
Action
mechanism: SRM003 is composed of allogenic human aortic endothelial cells cultured in a gelatin matrix, Gelfoam®. SRM003 is placed on the outside of the blood vessel at the arteriovenous (AV) access site during the surgical intervention for the treatment of vascular injury associated with the intervention.
Disease: Arteriovenous Fistula (AVF) maturation and AV Graft (AVG) patency to facilitate hemodialysis in patients with End Stage Renal Disease (ESRD)
Therapeutic area: Renal diseases - Kidney diseases
Country: USA
Trial
details: The first study, AVF01-SRM003, will evaluate the efficacy and safety of SRM003 in improving the rate of AVF maturation and use in subjects with ESRD undergoing surgery for the creation of an AVF in the upper extremity to facilitate hemodialysis access.
The second study, AVG01-SRM003, will evaluate the efficacy and safety of SRM003 in extending the duration of primary patency after placement of an AVG in the upper extremity in subjects with ESRD.
These are multi-center, single-blind, randomized, controlled studies, and they will enroll approximately 200 adult subjects each in 50 U.S. sites. In both studies, each treatment group will include approximately 100 subjects who will receive either SRM003 (two or three SRM003 sponges placed at time of AVF or AVG surgery, respectively) or standard practice at participating sites.
Latest
news: * On April 4, 2013, Shire has announced enrollment of the first patients in two Phase 2 studies designed to evaluate the efficacy and safety of SRM003 (VASCUGEL) in improving Arteriovenous Fistula (AVF) maturation and AV Graft (AVG) patency to facilitate hemodialysis in patients with End Stage Renal Disease (ESRD).
It is hypothesized that when placed outside the blood vessel, the seeded SRM003 gelatin matrix containing endothelial cells can provide a continuous supply of multiple growth regulatory compounds to the underlying cells within the blood vessel while being protected from the effects of blood flow in the vessel(s) or complications resulting from being in direct contact with the point of injury. Shire obtained the rights to Vascugel (developed under Shire as SRM003) when it acquired substantially all the assets of Pervasis Therapeutics in April 2012. This acquisition also provided Shire with a new cell-based technology platform.
SRM003 has received Orphan Product and Fast Track designation from the FDA and Orphan Product designation from the EMA.
