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NCT00392509 · ClinicalTrials.gov registry record · Phase 1
ALD-301 for Critical Limb Ischemia, Randomized Trial
A Phase 1 study of Peripheral Arterial Disease and Peripheral Vascular Disease, sponsored by Aldagen.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 5
- Study locations
NCT00392509 is a Phase 1 study of Peripheral Arterial Disease and Peripheral Vascular Disease that has completed, run by Aldagen. The registered enrollment target is 20 participants, below the 4,206-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (100% lower). The trial reports 5 study locations across 5 states.
The verdict
NCT00392509, a Phase 1 study of Peripheral Arterial Disease and Peripheral Vascular Disease, has completed, sponsored by Aldagen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 5
- Study locations
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 Studied
Interventions
- PROCEDURE ALDH-br bone marrow cells vs. mononuclear bone marrow cells
Study Locations (5)
Alabama
- Cardiology PC - Birmingham
Georgia
- Saint Joseph's Research Institute - Atlanta
Indiana
- University of Indiana at Indianapolis - Indianapolis
North Carolina
- Duke University Medical Center - Durham
Texas
- Texas Heart Institute, Stem Cell Center, 6770 Bertner, St Luke's Episcopal Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2006-10 |
| Est. Completion | 2008-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00392509
The ClinicalTrials.gov registry entry for NCT00392509 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,206-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (100% lower). The listed sponsor is Aldagen, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 1 intervention - of which ALDH-br bone marrow cells vs. mononuclear bone marrow cells is the first listed.
NCT00392509 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Alabama, Georgia, Indiana.
Frequently Asked Questions
What is clinical trial NCT00392509 about?
NCT00392509 is a clinical study titled "ALD-301 for Critical Limb Ischemia, Randomized Trial". 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 ran...
What is the current status of trial NCT00392509?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2006-10. Estimated completion is 2008-12.
What conditions does trial NCT00392509 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease, Peripheral Vascular Disease, Critical Limb Ischemia.
What interventions are being tested in trial NCT00392509?
The interventions under investigation include: ALDH-br bone marrow cells vs. mononuclear bone marrow cells (PROCEDURE).
Who is sponsoring clinical trial NCT00392509?
This trial is sponsored by Aldagen, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00392509 being conducted?
This trial has 5 study locations across Alabama, Georgia, Indiana, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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