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NCT01859117 · ClinicalTrials.gov registry record · Phase 1
Study of Human Placenta-derived Cells (PDA002) to Evaluate the Safety and Effectiveness in Subjects With PAD and DFU
A Phase 1 study of Peripheral Arterial Disease and Diabetic Foot, sponsored by Celularity Incorporated.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 11
- Study locations
NCT01859117 is a Phase 1 study of Peripheral Arterial Disease and Diabetic Foot that has completed, run by Celularity Incorporated. The registered enrollment target is 15 participants, below the 4,206-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (100% lower). The trial reports 11 study locations across 8 states.
The verdict
NCT01859117, a Phase 1 study of Peripheral Arterial Disease and Diabetic Foot, has completed, sponsored by Celularity Incorporated.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 11
- Study locations
Study Summary
This clinical study is being conducted to assess the safety and determine the maximum tolerated dose (MTD) of PDA-002 \[human placenta-derived cells\] administered into the lower leg muscles of subjects with peripheral arterial disease and diabetic foot ulcers. It will look to see if PDA-002 helps reduce some of the symptoms of PAD and/or improves ulcer healing. This study will also help to find the best dose of PDA-002 to use in future studies.
Conditions Studied
Interventions
- BIOLOGICAL 3 x 10^6 cells
- BIOLOGICAL 10 x 10^6 cells
- BIOLOGICAL 30 x 10^6 cells
- BIOLOGICAL 100 x 10^6 cells
Study Locations (11)
California
- UCLA - Los Angeles
- Stanford University School of Medicine - Stanford
Illinois
- Dr. Wiliam M. Scholl College of Podiatric Medicine - North Chicago
- Southern Illinois University School of Medicine - Springfield
Texas
- Complete Family Foot Care - McAllen Office - McAllen
- Endeavor Clinical Trials PA - San Antonio
Arizona
- Carl T. Hayden Veterans Affairs Medical Center - Phoenix
North Carolina
- University of North Carolina School of Medicine - Chapel Hill
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Virginia
- University of Virginia - Charlottesville
Wisconsin
- University of Wisconsin - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2013-05 |
| Est. Completion | 2016-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01859117
The ClinicalTrials.gov registry entry for NCT01859117 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,206-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (100% lower). The listed sponsor is Celularity Incorporated, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 4 interventions - of which 3 x 10^6 cells is the first listed.
NCT01859117 reports 11 study locations spanning 8 distinct geographic areas - top geographies include California, Illinois, Texas.
Frequently Asked Questions
What is clinical trial NCT01859117 about?
NCT01859117 is a clinical study titled "Study of Human Placenta-derived Cells (PDA002) to Evaluate the Safety and Effectiveness in Subjects With PAD and DFU". This clinical study is being conducted to assess the safety and determine the maximum tolerated dose (MTD) of PDA-002 \[human placenta-derived cells\] administered into the lower leg muscles of subjects with peripheral arterial disease and diabetic foot ulcers. It will look to see if PDA-002 helps r...
What is the current status of trial NCT01859117?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2013-05. Estimated completion is 2016-10.
What conditions does trial NCT01859117 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease, Diabetic Foot.
What interventions are being tested in trial NCT01859117?
The interventions under investigation include: 3 x 10^6 cells (BIOLOGICAL), 10 x 10^6 cells (BIOLOGICAL), 30 x 10^6 cells (BIOLOGICAL), 100 x 10^6 cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT01859117?
This trial is sponsored by Celularity Incorporated, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01859117 being conducted?
This trial has 11 study locations across Arizona, California, Illinois, North Carolina, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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