CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 82 enrolled
Drug / intervention
ALD-301 +1 morebiological
Likely dose
ALD-301 1mlfrom 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/NCT01774097
NCT01774097Phase 2Completed
CompareCT.gov

Clinical and MR Imaging Assessments in Patients With Intermittent Claudication Following Injection of Bone Marrow Derived ALDH Bright Cells

The University of Texas Health Science Center, Houston·interventional·Posted Jan 23, 2013·Updated Apr 21, 2017

In Brief

A Phase 2 clinical trial evaluating ALD-301 and Placebo (vehicle) for Peripheral Artery Disease and Intermittent Claudication. Completed, enrolled 82 participants across 9 sites.

Detailed Summary

The purpose of this study is to find out if aldehyde dehydrogenase bright (ALDHbr) cells taken from a patient's bone marrow can be placed safely, via intramuscular injections, into their affected calf and lower thigh muscles and improve blood flow and/or peak walking time in patients experiencing pain associated with blocked blood vessels in the leg.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Artery Disease, Intermittent Claudication
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), Aldagen, Center for Cell and Gene Therapy, Baylor College of Medicine

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 23, 2013
Enrollment StartJun 1, 2013
Primary CompletionAug 1, 2016
Study CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 13.4 years ago

Interventions

ALD-301biological

Ten 1ml injections of ALD-301 in the index calf and posterior, lower thigh

Placebo (vehicle)biological

Ten 1ml injections of placebo in the index calf and posterior, lower thigh