NCT02460081

Safety, Hemodynamic Effects and Efficacy of Intramuscular PDA-002 in Subjects Who Have Diabetic Foot Ulcer With Peripheral Arterial Disease

A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose Range Finding Study to Evaluate the Safety, Hemodynamic Effects and Efficacy of Intramuscular Injection of Human Placenta-derived Cells (Pda-002) in Subjects Who Have Diabetic Foot Ulcer With Peripheral Arterial Disease

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Celularity Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study PDA-002-DFU-003 is a Phase 2, multicenter, randomized, double blind, placebo-controlled, dose range finding study in subjects who have diabetic foot ulcer (DFU) with peripheral arterial disease (PAD). The study will enroll approximately 24 subjects. This study will investigate the hemodynamic effects, clinical efficacy, and safety of 3 monthly intramuscular (IM) injections of PDA-002 in subjects who have DFU with PAD.

Conditions

• Diabetic Foot
• Peripheral Arterial Disease

Interventions

Type	Name	Description
DRUG	PDA-002
DRUG	Placebo

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2015-06-02
• Last updated: 2018-03-01

Locations

1 site across 1 country: United States