An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI)
Public ClinicalTrials.gov record NCT01483898. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy, Safety, And Tolerability Of Ixmyelocel-T In Subjects With Critical Limb Ischemia And No Options For Revascularization
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is designed to evaluate the efficacy and safety of ixmyelocel-T, a patient-specific expanded multicellular therapy, for the treatment of patients with critical limb ischemia (CLI). The study is a randomized, vehicle controlled (placebo)study in CLI patients who have no option for revascularization procedures. All patients randomized will undergo a small volume bone marrow aspiration in a 15-minute outpatient or in-office procedure. All patients will receive injections of either ixmyelocel-T or vehicle-control into their pre-identified index leg. Patients will be followed for 18 months.
Study identification
- NCT ID
- NCT01483898
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 41 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 35 Years to 90 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2012 (Type not available)
- Primary completion
- Mar 25, 2014 (Actual)
- Completion
- Mar 25, 2014 (Actual)
- Last update posted
- May 27, 2021
2012 – 2014
United States locations
- U.S. sites
- 86
- U.S. states
- 32
- U.S. cities
- 66
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cardiology PC | Birmingham | Alabama | 35211 | — |
| Cardio-Thoracic Surgeons, P.C. | Birmingham | Alabama | 35243 | — |
| University Of Alabama At Birmingham | Birmingham | Alabama | 35294 | — |
| Arizona Heart Institute | Phoenix | Arizona | 85006 | — |
| Carl T. Hayden VA Medical Center | Phoenix | Arizona | 85012 | — |
| University of Arizona | Tucson | Arizona | 85724 | — |
| Arkansas Primary Care Clinic, P.A. | Little Rock | Arkansas | 72204 | — |
| Central Arkansas Veteran's Healthcare System | Little Rock | Arkansas | 72205 | — |
| John Muir Medical Center - Concord Campus | Concord | California | 94520 | — |
| VA Loma Linda Healthcare | Loma Linda | California | 92357 | — |
| UCLA Gonda Venous Center & Ambulatory Procedure Unit | Los Angeles | California | 90095 | — |
| Sutter Medical Group - Cardiology | Sacramento | California | 95819 | — |
| University of California San Diego Medical Center | San Diego | California | 92103 | — |
| Kaiser Permanente Medical Center | San Diego | California | 92120 | — |
| University of California San Francisco - Division of Vascular and Endovascular Surgery | San Francisco | California | 94143-0222 | — |
| University of Colorado Denver - Anschutz Medical Campus | Aurora | Colorado | 80045 | — |
| Yale School of Medicine | New Haven | Connecticut | 06520 | — |
| Bethesda Memorial Hospital - Clinical Research Center | Boynton Beach | Florida | 33435 | — |
| Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | — |
| Florida Research Network, LLC | Gainesville | Florida | 32605 | — |
| Malcom Randall Veterans Affairs Medical Center | Gainesville | Florida | 32608 | — |
| First Coast Cardiovascular Institute, P.A. | Jacksonville | Florida | 32216 | — |
| University of Miami Hospital | Miami | Florida | 33136 | — |
| Orlando Health | Orlando | Florida | 32806 | — |
| Baptist Hospital | Pensacola | Florida | 32501 | — |
| Cardiology Consultants | Pensacola | Florida | 32501 | — |
| Grove Place Surgery Center | Vero Beach | Florida | 32960 | — |
| Vascular Surgical Associates, P.C. | Marietta | Georgia | 30060 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Illinois at Chicago - Clinical Sciences North | Chicago | Illinois | 60612 | — |
| Memorial Medical Center | Springfield | Illinois | 62702 | — |
| Indiana/Ohio Heart | Fort Wayne | Indiana | 46804 | — |
| St. Vincent Medical Group, Inc. | Indianapolis | Indiana | 46290 | — |
| Heartland Vascular Medicine and Surgery | Windsor Heights | Iowa | 50324 | — |
| Ochsner Clinic foundation | New Orleans | Louisiana | 70121 | — |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| Union Memorial Hospital | Baltimore | Maryland | 21218 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| UMASS Memorial Health Care | Worcester | Massachusetts | 01655 | — |
| VA Ann Arbor Healthcare System | Ann Arbor | Michigan | 48105 | — |
| Cardiology and Vascular Associates, P.C. | Berkley | Michigan | 48072 | — |
| Oakwood Hospital and Medical Center | Dearborn | Michigan | 48124 | — |
| John D. Dingell VA Medical Center | Detroit | Michigan | 48201 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Michigan Vascular Research Center | Flint | Michigan | 48507 | — |
| Integrated Vascular Vein Center of Michigan | Grand Blanc | Michigan | 48439 | — |
| Michigan CardioVascular Institutue at Covenant Medical Center | Saginaw | Michigan | 48602 | — |
| Saint Joseph Mercy Hospital | Ypsilanti | Michigan | 48197 | — |
| Abbott Northwestern Hospital / Minneapolis Heart Institute-Vascular Clinic | Minneapolis | Minnesota | 55407 | — |
| Minneapolis VA Health Care System | Minneapolis | Minnesota | 55417 | — |
| University of Minnesota Medical School | Minneapolis | Minnesota | 55455 | — |
| Hattiesburg Clinic, P.A. | Hattiesburg | Mississippi | 39401 | — |
| Saint Luke's Hospital | Kansas City | Missouri | 64111 | — |
| Omaha VAMC | Omaha | Nebraska | 68105 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Vascular Access Center of West Orange | West Orange | New Jersey | 07052 | — |
| University of Buffalo Surgeons Inc. | Buffalo | New York | 14203 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | — |
| University of North Carolina Hospital | Chapel Hill | North Carolina | 27599 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| Jobst Vascular Institute | Toledo | Ohio | 43606 | — |
| University of Toledo Medical Center | Toledo | Ohio | 43614 | — |
| University of Oklahoma Health Science Center | Oklahoma City | Oklahoma | 73104 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| Veterans' Administration Medical Center | Pittsburgh | Pennsylvania | 15232 | — |
| VA Pittsburgh Healthcare System | Pittsburgh | Pennsylvania | 15240 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | — |
| DFW Vascular Group, LLP | Dallas | Texas | 75208 | — |
| Texas Heart Institute at St. Luke's Episcopal Hospital | Houston | Texas | 77030 | — |
| The Methodist Hospital | Houston | Texas | 77030 | — |
| Audie L Murphy VA Hospital - Pathology Laboratory | San Antonio | Texas | 78229 | — |
| University of Utah | Salt Lake City | Utah | 84132 | — |
| Swedish Medical Center | Seattle | Washington | 98122 | — |
| University of Washington | Seattle | Washington | 98195 | — |
| Cascade Vascular Associates, P.S. | Tacoma | Washington | 98405 | — |
| Charleston Area Medical Center - Memorial Hospital | Charleston | West Virginia | 25304 | — |
| University of Wisconsin | Madison | Wisconsin | 53792 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53203 | — |
| Columbia Saint Mary's | Milwaukee | Wisconsin | 53211 | — |
| Wheaton Franciscan Medical Group, Inc. | Milwaukee | Wisconsin | 53217 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01483898, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 27, 2021 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01483898 live on ClinicalTrials.gov.