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.
The goal of this study is to determine a safe dose of PDA-002 \[human placenta-derived cells\] for further study. This is a dose-escalation study where each of four dose levels will enroll three to six subjects. Doses will be range from 3 million up to 100 million cells. If one dose is considered safe after all treated subjects have been evaluated and reviewed, then the next group of subjects will be enrolled to receive the next higher dose. This will continue until either the highest dose is reached, until at least 2 subjects at a dose level have ≥ Grade 2 allergic reaction that is suspected to be related to PDA-002 or 2 or more subjects at a dose level experience an unexpected, treatment-related serious adverse event or dose limiting toxicity within 14 days following the initial dose of PDA-002. This is an open-label study where all subjects will be taking the study drug and all study personnel will know the dose each subject receives.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
3 x 10\^6 cells administered on Study Days 1 and 8
10 x 10\^6 cells administered on Study Days 1 and 8
30 x 10\^6 Human Placenta Derived cells (PDA-002) administered intramuscularly on Study Days 1 and 8
Carl T. Hayden Veterans Affairs Medical Center
Phoenix, Arizona, United States
UCLA
Los Angeles, California, United States
Stanford University School of Medicine
Stanford, California, United States
Maximum tolerated dose
To determine the maximum tolerated dose (MTD) of PDA-002 administered intramuscularly (IM) in subjects with peripheral arterial disease (PAD) and DFU \[diabetic foot ulcer\].
Time frame: 14 days of initial dosing
Adverse Events
Number of participants with adverse events
Time frame: From signing informed consent until month 24
Ankle-brachial index (ABI)
at the ankle by the systolic blood pressures (Doppler technique) in the arm.
Time frame: Approximately 2 years
Toe-brachial index (TBI)
To assess changes in the TBI which is calculated by dividing the systolic blood pressure at the toe by the systolic blood pressures (Doppler technique) in the arm.
Time frame: Approximately 2 years
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100 x 10\^6 cells administered on Study Days 1 and 8
Dr. Wiliam M. Scholl College of Podiatric Medicine
North Chicago, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
University of North Carolina School of Medicine
Chapel Hill, North Carolina, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Complete Family Foot Care - McAllen Office
McAllen, Texas, United States
Endeavor Clinical Trials PA
San Antonio, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
...and 1 more locations