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

NCT01859117 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-03-01

No results posted yet for this study

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.

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 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

Sponsors & Collaborators

  • Celularity Incorporated

    lead INDUSTRY

Principal Investigators

  • Monica E Luchi, MD · Celularity Incorporated

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-10-31
Completion
2016-10-31

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 NCT01859117 on ClinicalTrials.gov