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ALD-301 for Critical Limb Ischemia, Randomized Trial

NCT00392509 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2009-05-14

No results posted yet for this study

Summary

This study will treat patients with such severe lower leg ischemia or vascular compromise that they have pain at rest. The goal is to compare treatment of the patient's painful disorder by injecting cells into the calf of the leg and testing for circulatory improvement. A treatment will given at random to two groups and will be injection into the calf muscle with ALD-301 (specially processed stem and progenitor cells) from the patient's own bone marrow, or with cells processed by more routine that minimally purifies the cells. The study goal is to see if the ALD-301 cells are more effective in generating new small blood vessels to improve the circulation to the affected leg.

Conditions

  • Critical Limb Ischemia
  • Peripheral Arterial Disease
  • Peripheral Vascular Disease

Interventions

PROCEDURE

ALDH-br bone marrow cells vs. mononuclear bone marrow cells

Surgery

Sponsors & Collaborators

  • Aldagen

    lead INDUSTRY

Principal Investigators

  • Emerson C Perin, M.D., Ph.D. · Stem Cell Center, Texas Heart Institute, St Luke's Episcopal Hospital, 6770 Bertner , Suite 1020 Texas Medical Center,Houston, Texas 77030

  • Robert Mitchell, MD · Duke University

  • Michael Murphy, MD · University of Indiana at Indianapolis

  • Nicolas Chronos, MD · Saint Joseph's Research Institute

  • Farrell Mendelsohn, MD · Cardiology PC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

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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 NCT00392509 on ClinicalTrials.gov