Safety and Efficacy of Allogeneic Cells for the Treatment of Intermittent Claudication(IC)
Public ClinicalTrials.gov record NCT01679990. 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 Phase II, Randomized, Double-Blind, Multicenter, Multinational, Placebo-Controlled, Parallel- Groups Study to Evaluate the Safety and Efficacy of Intramuscular Injections of Allogeneic PLX-PAD Cells for the Treatment of Subjects With Intermittent Claudication (IC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of the study is to establish the safety profile of Intramuscular PLX-PAD injections and to evaluate the clinical efficacy of it in IC subjects comprising of 4 treatment groups: 1. Double treatment of PLX-PAD low dose 2. Double treatment of PLX-PAD high dose 3. Double treatment of Placebo 4. Single treatment of PLX-PAD high dose and additional treatment of Placebo. Subjects will receive the assigned treatment twice to the affected leg, within 12-weeks interval between each treatment. The study will be comprised of 5 stages: Screening period of up to 4 weeks,first treatment of PLX-PAD or placebo followed by additional injection after 12 weeks and with follow-up of 12 months post second injection
Study identification
- NCT ID
- NCT01679990
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 180 participants
Conditions and interventions
Interventions
- PLX-PAD Low dose Biological
- PLX-PAD high doses Biological
- Double Placebo Biological
- high dose +Placebo Biological
Biological
Eligibility (public fields only)
- Age range
- 45 Years to 85 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
- Nov 4, 2012
- Primary completion
- Mar 28, 2018
- Completion
- Feb 8, 2019
- Last update posted
- Feb 11, 2019
2012 – 2019
United States locations
- U.S. sites
- 15
- U.S. states
- 13
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cardiology, P. C. and Center for Therapeutic Angiogenesis | Birmingham | Alabama | 35211 | — |
| Tampa Bay Medical Research | Clearwater | Florida | 33761 | — |
| Florida Researc Network, LLC | Gainesville | Florida | 32605 | — |
| DMI Research | Pinellas Park | Florida | 33782 | — |
| Dr. Nadarajah Janaki | Evans | Georgia | — | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Kentucky Research Foundation | Lexington | Kentucky | 40506-0057 | — |
| Cardiovascular Division, MMC, University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Cardiovascular Institute, Mount Sinai School of Medicine | New York | New York | 10029 | — |
| Duke University | Durham | North Carolina | — | — |
| Dr. Mohler Emile | Philadelphia | Pennsylvania | — | — |
| Omega Medical Center | Warwick | Rhode Island | 02886 | — |
| Turkey Creek Medical Center | Knoxville | Tennessee | 10820 | — |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 19 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01679990, 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 Feb 11, 2019 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01679990 live on ClinicalTrials.gov.