A Phase 2 interventional study of ADRCs processed by the Celution System and Placebo Comparator: Lactated Ringer's and Subject's Blood in Myocardial Ischemia, sponsored by Cytori Therapeutics. Completed at 8 sites in United States. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-10-28.
Sponsored by Cytori Therapeutics · Phase 2, Interventional, and Treatment
Among 218 studies in Myocardial Ischemia with a site in United States — 23 open to participants now, 26 under way, none of them phase 3. Myocardial Ischemia · United States.
Among the 218 studies in Myocardial Ischemia with a site in United States, this one is the 112th largest by enrollment of the 150 interventional ones that give a count, is one of 10 that started in 2012, is one of 27 in phase 2, and was the 107th registered.
1,123 studies on the registry are indexed under Myocardial Ischemia; 177 are open to participants now.
Browse Myocardial Ischemia studies →23 of the 218 studies in Myocardial Ischemia with a site in United States are open now. Recruiting first, the newest first:
Bettina Mittendorfer · Sites in United States
Medtronic Cardiac Ablation Solutions · Sites in United States
Teleflex · Sites in United States, Latvia
The Cleveland Clinic · Sites in United States
Mayo Clinic · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 135 Myocardial Ischemia studies recruiting now, 92 (68%) set no upper age limit and 6 (4%) stop at 75 or younger; 14 take children under 18; 20 take healthy volunteers.
This study: 20 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
218 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 16 · Phase 2 31 · Phase 3 21 · Phase 4 19
First in 1990; this study’s year is marked. 10 started in 2012.
This study's enrollment of 28 is below the median of 116 across 622 interventional studies indexed under Myocardial Ischemia.
Median enrollment 87 across the 150 interventional studies, 205 across the 67 observational. Of the 172 that completed or were terminated, 77 (45%) have results posted.
This tab as a report to print or save as PDF → With an account.
82 of 218 have an industry lead sponsor. The 10 most frequent:
Cytori Therapeutics is the lead sponsor of 19 studies on the registry; 2 are open to participants now.
Cytori Therapeutics has 3 studies filed under Myocardial Ischemia — fewer than ten, so there is no comparison to draw.
6 of the studies in Myocardial Ischemia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06703489Medtronic Cardiac Ablation SolutionsSafety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS) | 2026-11 |
| NCT06271577AliveCorSmartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II | 2026-12 |
| NCT02855554Medical University of South CarolinaQuantitative Cardiac Parametric Mapping | 2026-12 |
| NCT05788666NYU Langone HealthUse of GeriKit to Better Phenotype Older Adults With Ischemic Heart Disease | 2027-03-01 |
| NCT06047028University of Texas Southwestern Medical CenterPrognostic Value of Hyperpolarized 13C MRI for Clinical Myocardial Viability | 2027-06-30 |
Among the 218 studies in Myocardial Ischemia with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a prospective, randomized, placebo-controlled, double blind safety and feasibility clinical trial.
To assess the safety and feasibility of Adipose-Derived Regenerative Cells (ADRCs) delivered via an intramyocardial route in the treatment of chronic ischemic heart disease in patients who are not eligible for percutaneous or surgical revascularization.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
400,000 adipose-derived regenerative cells (ADRCs) per kilogram (kg) of body weight not to exceed 40,000,000 cells.
Device: ADRCs processed by the Celution System
Sterile Lactated Ringers Solution (3mL) mixed with ≤ 0.10 ml of the study Subject's own freshly drawn blood.
Device: Placebo Comparator: Lactated Ringer's and Subject's Blood
Subjects will undergo liposuction under anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs. When randomized to ADRCs, intramyocardial injections of ADRCs will be administered via the MYOSTAR injection catheter.
Also known as: ADRCs, Intramyocardial injections
Subjects will undergo liposuction under anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs. When randomized to Placebo, intramyocardial injections of Placebo will be administered via the MYOSTAR injection catheter.
Also known as: Placebo
Treatment emergent serious adverse events (SAEs), major adverse cardiac events (MACE), arrhythmia assessment, change in cardiac function and symptoms, and resource utilization
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
Time frame: 6 and 12 Months
The record gives a start of Jun 2012, a primary completion of Aug 2015 and a completion of Oct 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Cytori Therapeutics