Regeneration of injured Gluteal Musculature (GM) after Total Hip Arthroplasty (THA) MedDRA version: 14.1 Level: LLT Classification code 10048793 Term: Coxarthrosis System Organ Class: 100000004859
Conditions
Interventions
Product Name: PLX-PAD, adherent stromal cells (ASC)
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: PLX
CAS Number: n/a
Current Sponsor code: PLX
Other descriptive name: PLX cells
C
Sponsors
Pluristem Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult male or female subjects between 50 to 75 years of age at the time of screening visit. 2. Scheduled THA 3. ASA Score = 3 4. Signed written informed consent. 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 6 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 1. Muscle diseases 2. Sever neurological diseases 3. Opioid long term medication 4. Pain chronification > stadium II of Gerbershagen 5. Immunosuppression due to illness or medication 6. Ankylosing spondylitis 7. History ofectopic bone formation of any localisation 8. Exclusion criteria for MRI (pace maker, defibrillator, ferromagnetic intracerebral clips) 9. Uncontrolled hypertension (defined as diastolic blood pressure > 100 mmHg or systolic blood pressure > 200 mmHg during screening) 10. Life-threatening ventricular arrhythmia or unstable angina - characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged 11. ST segment elevation myocardial infarction and/or TIA/CVA within three (3) months prior to enrollment. Subjects with severe congestive heart failure symptoms (i.e. NYHA Stage IV) 12. Subject has malignancy undergoing treatment including chemotherapy, radiotherapy or immunotherapy 13. Body Mass Index (BMI) of 35 Kg/m2 or greater. 14. Known allergies to protein products (horse or bovine serum, or porcine trypsin) used in the cell production process 15. Known HIV, syphilis at time of screening 16. Known active Hepatitis B, or Hepatitis C infection at the time of screening 17. Pregnant or breast-feeding women or women of childbearing potential not protected by an effective contraceptive method of birth control (defined as pearl index < 1) 18. In the opinion of the investigator, the subject is unsuitable for cellular therapy 19. Subject is currently enrolled in, or has not yet completed a period of at least 30 days since ending other investigational device or drug trial(s) 20. Subjects who are legally detained in an official institute
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of this study are to further establish the safety of PLX-PAD local administration and to assess the efficacy of PLX-PAD single dose, intra-muscular injection for the regeneration of injured GM after THA.;Secondary Objective: The objectives of this study are to further establish the safety of PLX-PAD local administration and to assess the efficacy of PLX-PAD single dose, intra-muscular injection for the regeneration of injured GM after THA.;Primary end point(s): Efficacy Endpoints Primary Efficacy Endpoint at week 26 • Function of the GM assessing maximal contraction force ;Timepoint(s) of evaluation of this end point: The evaluation of this endpoints will be done on every visit (day 1 until week 12). Primary end-point: at week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety Endpoints • Adverse events • Safety laboratory values and ECG findings • Immunological reaction Secondary Efficacy Endpoint at week 12 and 26 • Macrostructure of GM; MRI will be performed at baseline (1 day before treatment) and at 6, 12 and 26 weeks following the THA, both muscle volume and fatty degeneration will be analyzed. • Microstructure of GM; biopsy will be performed at baseline (day of treatment) and 12 weeks after the THA, muscle fiber diameter, amount of fibrosis and fiber type changes will be analyzed • Clinical outcome: o Trendelenburgs´ sign o Gait analysis o Harris Hip Score (HHS) o Quality of Life (SF36) o Oxford-12-Hip Score o Western Ontario and McMaster Universities’ Arthritis-Index (WOMAC) o Pain assessment (VAS);Timepoint(s) of evaluation of this end point: At week 12 and 26. | — |
Countries
Germany
Contacts
Public ContactClinical Affairs
Pluristem Ltd.
Outcome results
None listed