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Treatment of Muscle Injury Following Arthroplasty for Hip Fracture (HF)

NCT03451916 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2023-09-28

No results posted yet for this study

Summary

The objectives of this study are to assess the efficacy, safety, and tolerability of PLX-PAD intramuscular administration for the treatment of muscle injury following arthroplasty for HF.

Conditions

  • Hip Fracture

Interventions

DRUG

PLX-PAD

PLX-PAD (120 subjects): 150×10\^6 PLX-PAD cells (10×10\^6 cells/mL) in a mixture containing 10% DMSO (v/v), 5% HSA (w/v) and PlasmaLyte

DRUG

Placebo

Arm 2 Placebo (120 subjects): Placebo (solution comprised of 10% DMSO \[v/v\], 5% HSA \[w/v\], and PlasmaLyte, without cells).

Sponsors & Collaborators

  • Pluristem Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
0 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-26
Primary Completion
2022-04-29
Completion
2023-09-06
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Germany
  • Israel
  • United Kingdom

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 NCT03451916 on ClinicalTrials.gov