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.
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: 1. 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. 2. 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 survival and quality of life data, serious adverse events (SAEs) and new malignancy adverse events will be collected. The main study period will comprise 4 periods: 1. Screening and pre-surgery time 2. Surgery and treatment with PLX-PAD or placebo (Day 0) 3. Hospital follow-up until Day 5±1, at least 4. 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
240
University Of California Davis,4860 Y Street
Sacramento, California, United States
Denver Metro Orthopedics, P.C. 499 E. Hampden Avenue, Suite 140 Englewood, CO 80113
Denver, Colorado, United States
Short Physical Performance Battery (SPPB) score
Time frame: Week 26.
Hip abduction strength of the injured leg
Time frame: Week 26.
Change from baseline to Week 52 in lower extremity measure (LEM) (retrospective collection of pre-fracture LEM at Day 5±1).
Time frame: baseline to Week 52
SPPB score
The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremities function. The SPPB consists of 3 types of physical maneuvers: balance test, speed gait test, and chair stand test. Results from each maneuvers test are scored on a scale of 0 to 4, with an increasing composite score indicating an improved lower extremities function level. The total maximum score of SPPB is 12.
Time frame: Week 52.
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MHAT "Ljulin" Department of Orthopedy and Traumatology
Sofia, Bulgaria
MHAT "Serdika" Department of Orthopedy and Traumatology
Sofia, Bulgaria
Military Medical Academy
Sofia, Bulgaria
Specialized Hospital for Active Treatment in Orthopedy
Sofia, Bulgaria
Charite - Campus Mitte,Campus Virchow-Klinikum
Berlin, Germany
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden
Dresden, Germany
Universitaetsklinikum Muenster
Münster, Germany
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