NCT01859117

Study of Human Placenta-derived Cells (PDA002) to Evaluate the Safety and Effectiveness in Subjects With PAD and DFU

A Phase 1 Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of Intramuscular Injection of Human Placenta-Derived Cells (PDA-002) in Subjects With Peripheral Arterial Disease and Diabetic Foot Ulcer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Celularity Incorporated · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This clinical study is being conducted to assess the safety and determine the maximum tolerated dose (MTD) of PDA-002 \[human placenta-derived cells\] administered into the lower leg muscles of subjects with peripheral arterial disease and diabetic foot ulcers. It will look to see if PDA-002 helps reduce some of the symptoms of PAD and/or improves ulcer healing. This study will also help to find the best dose of PDA-002 to use in future studies.

Detailed description

The goal of this study is to determine a safe dose of PDA-002 \[human placenta-derived cells\] for further study. This is a dose-escalation study where each of four dose levels will enroll three to six subjects. Doses will be range from 3 million up to 100 million cells. If one dose is considered safe after all treated subjects have been evaluated and reviewed, then the next group of subjects will be enrolled to receive the next higher dose. This will continue until either the highest dose is reached, until at least 2 subjects at a dose level have ≥ Grade 2 allergic reaction that is suspected to be related to PDA-002 or 2 or more subjects at a dose level experience an unexpected, treatment-related serious adverse event or dose limiting toxicity within 14 days following the initial dose of PDA-002. This is an open-label study where all subjects will be taking the study drug and all study personnel will know the dose each subject receives.

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 cells 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
BIOLOGICAL	100 x 10^6 cells	100 x 10\^6 cells administered on Study Days 1 and 8

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2013-05-21
• Last updated: 2018-03-01

Locations

11 sites across 1 country: United States