Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of Peripheral Arterial Disease and Diabetic Foot, sponsored by Celularity Incorporated.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of participants with dose-limiting toxicities following intramuscular administration of PDA-002. Dose-limiting toxicity was used to evaluate maximum tolerated dose.
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 |
What the finished NCT01859117 record still lists
NCT01859117 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 4,206-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (100% lower).
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 lists 11 locations in 8 states (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.
Learn More About Clinical Trials
Similar trials for Peripheral Arterial Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01859117's enrollment target sits among peer trials
15 71st of 79 higher than 7 of 79 other Peripheral Arterial Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Arterial Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Effects of Carnosine In Patients With Peripheral Arterial Disease Patients
RECRUITING · Phase 1
-
Carnosine for Peripheral Arterial Disease Patients
RECRUITING · Phase 1
-
BGC101 (EnEPC) Autologous Cell Therapy From Patient's Own Blood for Treatment of Critical Limb Ischemia (CLI)
ACTIVE NOT RECRUITING · Phase 1
-
Natural Vascular Scaffold (NVS) Therapy for Treatment of Atherosclerotic Lesions (Activate I)
COMPLETED · Phase 1
-
A Clinical and Histological Analysis of Mesenchymal Stem Cells in Amputation
COMPLETED · Phase 1
-
ALD-301 for Critical Limb Ischemia, Randomized Trial
COMPLETED · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01889381 · 15 participants · Phase 2
Human Craniomaxillofacial Allotransplantation
- NCT02530073 · 15 participants · NA
Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH
- NCT02535936 · 15 participants · NA
Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy
- NCT02918474 · 15 participants · NA
Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia