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NCT02552277 · ClinicalTrials.gov registry record · Phase 2
A Efficacy and Safety Study of Intramuscular Injection of Human Placenta-Derived Cells (PDA-002) in Subjects With Diabetic Peripheral Neuropathy
A Phase 2 study, sponsored by Celularity Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT02552277: Completed Phase 2 study, sponsored by Celularity Incorporated.
NCT02552277 is a Phase 2 study that has completed, run by Celularity Incorporated. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02552277, a Phase 2 study, has completed, sponsored by Celularity Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study Summary
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).
Primary Outcome
Epidermal nerve fiber density is a measurement used to assess the extent of peripheral diabetic neuropathy. The number of nerve fibers in a skin biopsy will be counted and quantified. A reduction in the number of nerves fibers (EPND)is indicative of worsening neuropathy.
Interventions
- DRUG Placebo
- BIOLOGICAL PDA-002
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2015-10-27 |
| Est. Completion | 2017-10-30 |
| Phase | Phase 2 |
What the finished NCT02552277 record still lists
NCT02552277 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02552277 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02552277 about?
NCT02552277 is a clinical study titled "A Efficacy and Safety Study of Intramuscular Injection of Human Placenta-Derived Cells (PDA-002) in Subjects With Diabetic Peripheral Neuropathy". 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 1...
What is the current status of trial NCT02552277?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2015-10-27. Estimated completion is 2017-10-30.
What interventions are being tested in trial NCT02552277?
The interventions under investigation include: Placebo (DRUG), PDA-002 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02552277?
This trial is sponsored by Celularity Incorporated, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02552277's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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