NCT02264288

Efficacy and Safety of Intramuscular PDA-002 in Subjects Who Have Diabetic Foot Ulcer With and Without Peripheral Arterial Disease

A Phase 2 Multicenter, Randomized, Doubleblind, Placebo-Controlled, Dose Range Finding Study to Evaluate the Efficacy and Safety of Intramuscular Injection of Human Placenta-derived Cells (Pda-002) in Subjects Who Have Diabetic Foot Ulcer With Peripheral Arterial Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Celularity Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The PDA-002-DFU-002 trial is a Phase 2, multicenter, randomized, double blind, placebo controlled, dose range finding study. The study will enroll approximately 133 subjects in four treatment groups. The primary objective of the study is to assess the efficacy and safety of PDA-002 administered intramuscular (IM) in subjects who have DFU with and without PAD. The secondary objective is to explore potential clinical efficacy by assessing changes in vascular parameters such as Ankle-Brachial Index and Toe-Brachial Index (ABI and/or TBI), Transcutaneous oxygen measurements (TcPO2).

Conditions

• Peripheral Arterial Disease
• Diabetic Foot

Interventions

Type	Name	Description
BIOLOGICAL	3 x 10^6 cells	3 x 10\^6 cells administered on Study Days 1 and 8
BIOLOGICAL	10 x 10^6 cells	10 x 10\^6 Human Placenta Derived cells (PDA-002) administered on Study Days 1 and 8
BIOLOGICAL	30 x 10^6 cells	30 x 10\^6 Human Placenta Derived cells (PDA-002) administered intramuscularly on Study Days 1 and 8
OTHER	Placebo	Identical matching placebo administered IM on Study Days 1 and 8

Timeline

• Start date: 2014-10-23
• Primary completion: 2018-02-28
• Completion: 2018-02-28
• First posted: 2014-10-15
• Last updated: 2020-07-22

Locations

55 sites across 1 country: United States