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

NCT02264288 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2020-07-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Celularity Incorporated

    lead INDUSTRY

Principal Investigators

  • Solveig Ericson, MD · Celularity Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-23
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02264288 on ClinicalTrials.gov