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Study of Human Placenta-derived Cells (PDA002) to Evaluate the Safety and Effectiveness in Subjects With PAD and DFU
NCT01859117 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celularity Incorporated, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01859117 reports 11 study locations spanning 8 distinct geographic areas — top geographies include California, Illinois, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01859117?
This trial is sponsored by Celularity Incorporated, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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