E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Regeneration of injured Gluteal Musculature (GM) after Total Hip Arthroplasty (THA) |
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E.1.1.1 | Medical condition in easily understood language |
Renewal of injured hip muscles after total hip replacement surgery |
Regeneration der verletzten Hüftmsukulatur nach operativem Hüftgelenksersatz |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048793 |
E.1.2 | Term | Coxarthrosis |
E.1.2 | System Organ Class | 100000004859 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy Endpoints Primary Efficacy Endpoint at week 26 • Function of the GM assessing maximal contraction force
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E.5.1.1 | 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
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E.5.2 | 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) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |