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NCT01774097 · ClinicalTrials.gov registry record · Phase 2
Patients With Intermittent Claudication Injected With ALDH Bright Cells
A Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 2
- Development phase
- 82
- Enrollment target
NCT01774097: Completed Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.
NCT01774097 is a Phase 2 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 82 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01774097, a Phase 2 study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 82 participants
- Enrollment target
Study 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.
Primary Outcome
The placebo adjusted average change over time in the maximum time (in minutes) walked by a patient on a treadmill under standardized conditions. The patient continues the test until walking can no longer be tolerated because of claudication symptoms.
Interventions
- BIOLOGICAL ALD-301
- BIOLOGICAL Placebo (vehicle)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2013-06 |
| Est. Completion | 2017-03 |
| Phase | Phase 2 |
What the finished NCT01774097 record still lists
NCT01774097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 2 interventions - of which ALD-301 is the first listed.
NCT01774097 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01774097 about?
NCT01774097 is a clinical study titled "Patients With Intermittent Claudication Injected With ALDH Bright Cells". 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 pa...
What is the current status of trial NCT01774097?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2013-06. Estimated completion is 2017-03.
What interventions are being tested in trial NCT01774097?
The interventions under investigation include: ALD-301 (BIOLOGICAL), Placebo (vehicle) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01774097?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01774097's enrollment target sits among peer trials
82 830th of 2000 higher than 1,167 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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