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Estimated Study Completion Date:
July 1, 2021
Treatment of Muscle Injury Following Arthroplasty for Hip Fracture (HF)
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ClinicalTrials.gov Identifier: NCT03451916
Recruitment Status : Recruiting
First Posted : March 2, 2018
Last Update Posted : April 30, 2019
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Sponsor:
Pluristem Ltd.
Information provided by (Responsible Party):
Pluristem Ltd.
Study Details
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Study Description
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Brief 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.
Condition or disease Intervention/treatment Phase Hip FractureDrug: PLX-PADDrug: PlaceboPhase 3
Detailed Description:
This will be a Phase III, multinational, randomized, double-blind, placebo-controlled study, assessing the efficacy, safety, and tolerability of intramuscular (IM) administration of allogeneic PLX-PAD cells for the treatment of muscle injury following arthroplasty for HF as compared to placebo treatment. Both treatment arms will receive standard of care treatment per local practice.
The study will comprise 2 periods:
Main study period - from Screening to 52 weeks post-treatment. During this period, the subjects will have the following study visits: Screening, Day 0 (treatment and surgery day), Day 1, Day 5, Week 6, Week 12, Week 26 and Week 52.
Safety follow-up period - from Week 52 to Week 104. During this safety follow-up period, there will be a phone call visit at Week 104, and only related serious adverse events (SAEs) and new malignancy adverse events will be collected.
The main study period will comprise 4 periods:
Screening and pre-surgery time
Surgery and treatment with PLX-PAD or placebo (Day 0)
Hospital follow-up until Day 5±1, at least
Follow-up period up to 52 weeks following study treatment administration. Subjects will be assessed for study eligibility before the emergency surgery for HF. After being found eligible, subjects will be randomized using a 1:1 allocation scheme to either 150×106 PLX-PAD cells or to placebo treatment, respectively. Within 48 hours of admission and up to 72 hours following fracture, subjects will undergo HA or THA. During the surgical procedure, the subjects will receive the investigational product in accordance with the treatment group to which they were randomized. Thereafter, visits will be conducted at Days 1 and 5±1, and at Weeks 6, 12, 26, 52 and 104.
Study Design
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Study Type :Interventional (Clinical Trial)Estimated Enrollment :240 participantsAllocation:RandomizedIntervention Model:Sequential AssignmentIntervention Model Description:, subjects will be randomized using a 1:1 allocation scheme to either 150×106 PLX-PAD cells or to placebo treatment, respectivelyMasking:Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose:TreatmentOfficial Title:Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, Designed to Determine the Efficacy, Safety, and Tolerability of Intramuscular Administration of Allogeneic PLX-PAD Cells for the Treatment of Muscle Injury Following Arthroplasty for Hip FractureActual Study Start Date :July 26, 2018Estimated Primary Completion Date :July 1, 2020
Estimated Study Completion Date :July 1, 2021
Resource links provided by the National Library of Medicine?
MedlinePlus related topics: Fractures Hip Injuries and Disorders
Drug Information available for: PlasmaLyte
U.S. FDA Resources
