PLX-HF-01_Ph3 IMP PLX-PAD in Patients with Hip Fracture
Research type
Research Study
Full title
A 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 Fracture (HF)
IRAS ID
243775
Contact name
Matthew Costa
Contact email
Sponsor organisation
Pluristem Ltd.
Eudract number
2017-005165-49
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 2 months, 28 days
Research summary
Research Summary:
This clinical study is trying to see if the investigational product, PLX-PAD, is helping treating the muscle injury after a hip surgery following a hip fracture, compared to placebo treatment.
Hip fractures (HF) in older adults are a high risk of death and major morbidity. The only treatment for HF is surgery, where the fractured bone is replaced with artificial implants or repaired with an internal fixation procedure. During the surgery, the muscles will be further injured, in addition to the initial injury caused by the fracture itself. These muscle injuries will cause loss of muscle mass and strength and lead to reduced mobility after recovering from the hip surgery. Currently, there are no approved medical treatments to improve the recovery of the muscle after a hip surgery. This investigational product it is hoped to help improve the recovery of the muscle after the hip surgery.
This study will involve 240 patients from: United Kingdom, Germany, Poland, Denmark, Israel and United States of America and the investigational product (either the active treatment, either placebo) will be administrated once, through intramuscular injections during the hip surgery. The patients will be in the active part of the study for 52 weeks, when they will visit the Hospital for study procedures and 52 weeks for the safety follow up period, when the patients will be called once by the study team to see how they are feeling.Summary of Results:
The primary endpoint of this study, the Short Physical Performance Battery (SPPB) score at Week 26, was not significantly different between the two study arms (6.873 in the PLX-PAD arm and 7.039 in placebo). Results of sensitivity analyses to the primary endpoint, both related and unrelated to missing data, aligned with this observation. Likewise, consistent results were shown in various tested sub-groups, with no statistically significant differences between the two study arms.
These findings, however, should be assessed with caution due to the fact that the study population was elderly and had a high rate of comorbidities. In this type of population, performance-based analyses such as the SPPB score used in the study’s primary objective may be limited in their ability to detect potential changes in the patients’ function as impacted by muscle strength and volume.
Thus, the primary endpoint in this study may not be an optimal measure of PLX-PAD potential efficacy in the study population.REC name
South Central - Oxford A Research Ethics Committee
REC reference
18/SC/0306
Date of REC Opinion
2 Jan 2019
REC opinion
Further Information Favourable Opinion