Muscle Injury Following Arthroplasty for Hip Fracture MedDRA version: 20.0 Level: HLT Classification code 10028315 Term: Muscle injuries System Organ Class: 100000004859
Conditions
Interventions
Product Name: PLX-PAD
Pharmaceutical Form: Dispersion for injection
INN or Proposed INN: Allogenic ex-vivo expanded placental adherent stromal cells (emiplacel)
Current Sponsor code: PLX-PAD
Concentra
Sponsors
Pluristem Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the inclusion criteria listed below to be eligible for the study: 1. Male or female subjects. 2. Subjects 60 to 90 years of age, inclusive, at the time of Screening. 3. Subjects suffering low energy trauma with intracapsular neck of femur fracture. 4. Planned to be treated with THA or HA, via direct lateral approach, within 48 hours of hospital admission and 72 hours post-fracture. 5. Subject able to walk 10 feet/3 meters before the fracture (with or without walking aids and without help of a person most of the time), based on self-report. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 36 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 204
Exclusion criteria
Exclusion criteria: Subjects with any 1 of the exclusion criteria listed below will not be eligible for the study: 1. Any significant musculoskeletal (including ectopic bone formation), neurologic or neuromuscular disease causing muscle weakness and/or affecting mobility at the time of Screening, based on the Investigator’s judgment. 2. Current fracture is due to bone pathology other than osteoporosis (as diagnosed on the pre-operative X-ray) or due to high-energy trauma (e.g., car accident). 3. Planned orthopedic surgery on lower limbs (excluding hip arthroplasty) within the next 12 months. 4. Diabetes mellitus with glycosylated hemoglobin (HbA1c) >10% at Screening. 5. Known current or history of proliferative retinopathy or diabetic retinopathy. 6. Known active Hepatitis B virus or Hepatitis C virus infection at Screening. 7. Known human immunodeficiency virus (HIV) infection, severe uncontrolled inflammatory disease or severe uncontrolled autoimmune disease (e.g., ulcerative colitis, Crohn’s disease, etc). 8. Immunosuppression due to illness or medication (e.g., high dose corticosteroids, calcineurin inhibitors, anti-tumor necrosis factor (TNF), anti-IL-6, anti-p40, etc; prednisone equivalent lower than 10 mg/day is accepted) at the time of Screening. 9. AST or ALT >3× upper limit of normal (ULN). 10. Subjects on renal replacement therapy or with estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2 (based on Modification of Diet in Renal Disease [MDRD] equation). 11. Severe congestive heart failure symptoms (New York Heart Association [NYHA] Stage IV) at Screening. 12. Known uncontrolled severe hypertension. 13. Treatment with anabolic steroids within 6 months prior to Screening. 14. Albumin <2.5 g/dL. 15. Active malignancy or history of malignancy within 3 years prior to Screening with the exception of successfully resected basal cell carcinoma or skin squamous cell carcinoma not located on the injured leg. 16. Known diagnosis of moderate to severe dementia based on subject’s medical history, past Mini-Mental State Examination test score of =18 or equivalent, or severe psychiatric disorder. 17. Known allergies to any of the following: DMSO, HSA, bovine serum albumin, PlasmaLyte and gentamicin (and other aminoglycoside antibiotics). 18. History of allergic/hypersensitivity reaction to any substance having required hospitalization and/or treatment with IV steroids/epinephrine, history of acute transfusion reaction, known allergy to more than 3 allergens, or in the opinion of the Investigator the subject is at high risk of developing severe allergic/hypersensitivity reactions. 19. Known history of severe atopic disease (including but not limited to chronic urticaria, respiratory allergy requiring oral steroids), known history of uncontrolled asthma (Global Initiative for Asthma [GINA] III-IV) 20. Pulmonary disease requiring supplemental oxygen treatment on a daily basis. 21. Known history of drug or alcohol abuse in the past 12 months, based on self-report or medical record. 22. History of autologous/allogeneic BM or solid organ transplantation. 23. Exposure to allogeneic cell-based therapy in the past or exposure to autologous cell therapy in the last 12 months before Screening. 24. Current evidence/sign supporting an assessment of life expectancy of less than 6 months, for reasons other than HF complications, based on the Investigator’s judgment. 25. Subject is currently enrolled in an investigational device or drug trial, or has not yet co
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of this study are to assess the efficacy, safety and tolerability of PLX-PAD IM administration for the treatment of muscle injury following arthroplasty for hip fracture.;Secondary Objective: Not applicable;Primary end point(s): Short Physical Performance Battery (SPPB) score at Week 26.;Timepoint(s) of evaluation of this end point: At weeks 6, 12, 26 and 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints: • Hip abduction strength of the injured leg at Week 26. • Change from baseline to Week 52 in lower extremity measure (LEM). • SPPB score at Week 52. • All-cause mortality rate. Safety Endpoints: • Adverse events (AEs) and SAEs. • Safety laboratory data (hematology, biochemistry). • Vital signs. • Physical examination findings. Tolerability Endpoints: • Proportion of subjects (%) who prematurely discontinued from the study. • Proportion of subjects (%) who prematurely discontinued from the study due to AEs.;Timepoint(s) of evaluation of this end point: Secondary Efficacy Endpoints: • Hip abduction strength of the injured leg: Weeks 6, 12, 26, 52 • Lower extremity measure (LEM): Day 5, Weeks 6, 12, 26, 52 • SPPB score: Weeks 6, 12, 26, 52 • All-cause mortality rate: throughout the study Safety Endpoints: • AEs and SAEs: throughout the study • Safety laboratory data (hematology, biochemistry): Screening, Days 1, 5; Weeks 6, 12, 26, 52 • Vital signs: Screening, Days 0, 1, 5; Weeks 6, 12, 26, 52 • Physical examination Screening, Day 5; Weeks 6, 12, 26, 52. Tolerability Endpoints: throughout the study | — |
Countries
Bulgaria, Denmark, Germany, Israel, United Kingdom, United States
Contacts
Public ContactVP Clinical & Medical Affairs
Pluristem Ltd
Outcome results
None listed