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ALD-301 for Critical Limb Ischemia, Randomized Trial
NCT00392509 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aldagen, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00392509 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Alabama, Georgia, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00392509?
The interventions under investigation include: ALDH-br bone marrow cells vs. mononuclear bone marrow cells (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00392509?
This trial is sponsored by Aldagen, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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