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Patients With Intermittent Claudication Injected With ALDH Bright Cells

NCT01774097 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2017-04-21

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

ALD-301

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

BIOLOGICAL

Placebo (vehicle)

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

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Aldagen

    collaborator INDUSTRY

  • Center for Cell and Gene Therapy, Baylor College of Medicine

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Robert Simari, MD · Cardiovascular Cell Therapy Research Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-08-31
Completion
2017-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01774097 on ClinicalTrials.gov