CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
PVS-10200biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01099215
NCT01099215Phase 2Completed

An Open-Label Dose Escalation Safety Study of PVS-10200 for the Treatment of Restenosis in Patients Undergoing Minimally Invasive Peripheral Revascularization (TRIUMPH)

Shire·interventional·Posted Apr 6, 2010·Updated Jun 28, 2021

In Brief

A Phase 2 clinical trial evaluating PVS-10200 for Peripheral Artery Disease. Completed, enrolled 21 participants across 3 sites.

Detailed Summary

The purpose of this study is to evaluate the safety of two doses of PVS-10200, an allogeneic cellular therapy, delivered as a single injection following percutaneous transluminal ("balloon") angioplasty and stent placement for the treatment of peripheral artery disease (PAD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 6, 2010
Enrollment StartApr 30, 2010
Primary CompletionJun 30, 2012
Study CompletionOct 31, 2012
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 16.2 years ago

Interventions

PVS-10200biological

PVS-10200 is composed of allogeneic human aortic endothelial cells cultured in a gelatin matrix.