A Efficacy and Safety Study of Intramuscular Injection of Human Placenta-Derived Cells (PDA-002) in Subjects With Diabetic Peripheral Neuropathy
Public ClinicalTrials.gov record NCT02552277. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Randomized, Double Blind, Placebo Controlled, Dose Range Finding Study to Access the Efficacy and Safety of Intramuscular Injection of Human Placenta- Derived Cells (PDA-002) in Subjects With Diabetic Peripheral Neuropathy.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT02552277
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 26 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 27, 2015 (Actual)
- Primary completion
- Mar 7, 2017 (Actual)
- Completion
- Oct 30, 2017 (Actual)
- Last update posted
- Feb 2, 2022
2015 – 2017
United States locations
- U.S. sites
- 7
- U.S. states
- 4
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Collaborative Neuroscience Network, LLC- Southland Neurologic Associates - Los Alamitos | Garden Grove | California | 92845 | — |
| SDS Clinial Trials, Inc | Orange | California | 92868 | — |
| Compass Research, LLC | Orlando | Florida | 32806 | — |
| Infinity Clinical Research, LLC | Sunrise | Florida | 33351 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Nerve And Muscle Center Of Texas | Houston | Texas | 77099 | — |
| Endeavor Clinical Trials PA | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02552277, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 2, 2022 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02552277 live on ClinicalTrials.gov.