Bone Marrow Aspirate Concentrate (BMAC) for Treatment of Critical Limb Ischemia (CLI)
Public ClinicalTrials.gov record NCT01245335. 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
Pivotal Study of the Safety and Effectiveness of Autologous Bone Marrow Aspirate Concentrate (BMAC) for the Treatment of Critical Limb Ischemia Due to Peripheral Arterial Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Critical Limb Ischemia prevents the legs and feet from receiving oxygen and nutrients needed for proper function. This severe lack of blood flow can lead to painful legs while walking or at rest and can result in foot sores, ulcers, gangrene, and even amputation. The purpose of this study is to determine if injections of concentrated bone marrow into damaged tissues will result in improved blood flow. If successful, this treatment could improve blood flow to the lower limb, reduce pain, and reduce the frequency of limb amputations.
Study identification
- NCT ID
- NCT01245335
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 97 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- May 2011 (Type not available)
- Primary completion
- Aug 2015 (Actual)
- Completion
- Nov 2015 (Actual)
- Last update posted
- Dec 15, 2015
2011 – 2015
United States locations
- U.S. sites
- 34
- U.S. states
- 23
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294-0012 | — |
| Medical Center of South Arkansas | El Dorado | Arkansas | 71730 | — |
| USC Keck School of Medicine | Los Angeles | California | 90033 | — |
| Florida Hospital - Vascular Institute of Central Florida | Orlando | Florida | 32804 | — |
| Coastal Vascular & Interventional | Pensacola | Florida | 32503 | — |
| USF / Tampa General | Tampa | Florida | 33606 | — |
| University of Illinois-Chicago | Chicago | Illinois | 60612 | — |
| Cadence Health, Central DuPage Hospital | Winfield | Illinois | 60190 | — |
| Ochsner Clinic | New Orleans | Louisiana | 70121 | — |
| Maine Medical Ctr | Portland | Maine | 04102 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Beth Israel Deaconess | Boston | Massachusetts | 02215 | — |
| Kansas City Vascular | Kansas City | Missouri | 64116 | — |
| Mercy Hospital | St Louis | Missouri | 63141 | — |
| Dartmouth Hitchcock Medical Ctr | Lebanon | New Hampshire | 03756 | — |
| Cooper University Hospital | Camden | New Jersey | 08103 | — |
| Holy Name Medical Center | Teaneck | New Jersey | 07666 | — |
| North Shore-Long Island Jewish | Lake Success | New York | 11042 | — |
| St. Luke's Roosevelt | New York | New York | 10025 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| Regional Infectious Disease and Infusion Ctr | Lima | Ohio | 45801 | — |
| University of Oklahoma | Tulsa | Oklahoma | 74135 | — |
| Oregon Health Science University | Portland | Oregon | 97239 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Roper St Francis Medical Center | Charleston | South Carolina | 29401 | — |
| Greenville Health System | Greenville | South Carolina | 29615 | — |
| University of Tennessee | Knoxville | Tennessee | 37920 | — |
| Baylor Medical Ctr | Dallas | Texas | 75226 | — |
| University of Texas - Houston Medical School | Houston | Texas | 77030 | — |
| Peace Health Southwest Medical Center | Vancouver | Washington | 98682 | — |
| Charleston Area Medical Center Institute | Charleston | West Virginia | 25304 | — |
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 NCT01245335, 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 Dec 15, 2015 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01245335 live on ClinicalTrials.gov.