A Efficacy and Safety Study of Intramuscular Injection of Human Placenta-Derived Cells (PDA-002) in Subjects With Diabetic Peripheral Neuropathy
Completed · Phase 2 · Has a placebo group
Conditions studied: Diabetic Nephropathies, Peripheral Nervous System Diseases
In brief
This is a Phase 2, randomized, double-blind, placebo-controlled, dose range finding study in subjects who have diabetic peripheral neuropathy (DPN). The study will enroll approximately 24 subjects. Subjects will be randomized to receive one of 3 treatments: PDA-002 (3 x 10\^6 cells), PDA-002 (30 x 10\^6 cells), or placebo (vehicle control) in a 1:1:1 randomization approach. Investigational product or placebo will be administered monthly (3 administrations total on Study Days 1, 29, and 57).
Key facts
- Study ID
- NCT02552277
- Run by
- Celularity Incorporated
- People needed
- 26
- Starts
- 2015-10-27
- Expected to finish
- 2017-10-30
- Last updated by the study team
- 2022-02-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Collaborative Neuroscience Network, LLC- Southland Neurologic Associates - Los Alamitos — Garden Grove, California, United States
- SDS Clinial Trials, Inc — Orange, California, United States
- Compass Research, LLC — Orlando, Florida, United States
- Infinity Clinical Research, LLC — Sunrise, Florida, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Nerve And Muscle Center Of Texas — Houston, Texas, United States
- Endeavor Clinical Trials PA — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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