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NCT01556022 · ClinicalTrials.gov registry record · Phase 2
Safety and Feasibility Trial of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia
A Phase 2 study, sponsored by Cytori Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
NCT01556022: Completed Phase 2 study, sponsored by Cytori Therapeutics.
NCT01556022 is a Phase 2 study that has completed, run by Cytori Therapeutics. The registered enrollment target is 28 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01556022, a Phase 2 study, has completed, sponsored by Cytori Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
Study Summary
This is a prospective, randomized, placebo-controlled, double blind safety and feasibility clinical trial.
Primary Outcome
Safety endpoints include: 1. Treatment emergent SAEs 2. Arrhythmia assessment via Holter monitoring 3. MACE defined as cardiac death and hospitalization for heart failure Feasibility endpoints include: 1. Change in mVO2 at 6 months 2. Change in LVESV/LVEDV at 6 months 3. Change in ejection fraction at 6 months 4. Change in perfusion defect at 6 months 5. Resource utilization 6. Change in heart failure symptoms, angina, and quality of life through 12 months
Interventions
- DEVICE ADRCs processed by the Celution System
- DEVICE Placebo Comparator: Lactated Ringer's and Subject's Blood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2012-06 |
| Est. Completion | 2016-10 |
| Phase | Phase 2 |
What the finished NCT01556022 record still lists
NCT01556022 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which ADRCs processed by the Celution System is the first listed.
NCT01556022 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01556022 about?
NCT01556022 is a clinical study titled "Safety and Feasibility Trial of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia". This is a prospective, randomized, placebo-controlled, double blind safety and feasibility clinical trial.
What is the current status of trial NCT01556022?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2012-06. Estimated completion is 2016-10.
What interventions are being tested in trial NCT01556022?
The interventions under investigation include: ADRCs processed by the Celution System (DEVICE), Placebo Comparator: Lactated Ringer's and Subject's Blood (DEVICE).
Who is sponsoring clinical trial NCT01556022?
This trial is sponsored by Cytori Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01556022's enrollment target sits among peer trials
28 1677th of 2000 higher than 304 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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