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Safety and Efficacy of IM Injections of PLX-PAD for the Regeneration of Injured Gluteal Musculature After Total Hip Arthroplasty

NCT01525667 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-09-21

Study results available
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Summary

Local administration of PLX-PAD single dose, intra-muscular injection for the regeneration of injured gluteal musculature after Total Hip Arthroplasty (THA).

Conditions

  • Total Hip Arthroplasty
  • Muscle Injury

Interventions

BIOLOGICAL

150M PLX-PAD

Single course, multiple IM injections

BIOLOGICAL

300M PLX-PAD

Single course, multiple IM injections

BIOLOGICAL

Placebo

Single course, multiple IM injections

Sponsors & Collaborators

  • Pluristem Ltd.

    lead INDUSTRY

Principal Investigators

  • Carsten Perka, MD · Charité Universitätsmedizin Berlin, Dept. Of Orthopedic Surgery, Charitéplatz 1, 10117 Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-12-31
Completion
2015-06-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT01525667 on ClinicalTrials.gov