Phase 2
N=20
Safety and Efficacy of IM Injections of PLX-PAD for the Regeneration of Injured Gluteal Musculature After Total Hip Arthroplasty
Total Hip Arthroplasty · Muscle Injury
Bottom Line
View on ClinicalTrials.gov: NCT01525667 ↗Enrolled (actual)
20
Serious AEs
10.0%
Results posted
Feb 2015
Primary outcome: Primary: Change From Day 0 to Week 26 in the Maximal Voluntary Isometric Contraction (MVIC) Moment of the Injured Side to Assess Gluteus Medius Strength. — 31.17; 20.36; 5.43 Newtons — p=0.0067
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 150M PLX-PAD (Biological); 300M PLX-PAD (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Pluristem Ltd.
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Day 0 to Week 26 in the Maximal Voluntary Isometric Contraction (MVIC) Moment of the Injured Side to Assess Gluteus Medius Strength. |
31.17; 20.36; 5.43 | 0.0067 sig |
| SECONDARY Change From Day 0 to Week 26 in Muscle Volume. |
24.42; 15.62; 6.39 | 0.004 sig |
| SECONDARY Change From Day 1 to Week 12 in Mean Fiber Diameter. |
1.25; 0.28; -5.21 | 0.19 |
| SECONDARY Change From Day 0 to Week 26 in the Ratio of Injured to Contralateral Pelvic Shift . |
0.43; 0.28; 0.27 | 0.4 |
| SECONDARY Change From Day 0 to Week 26 in the Visual Analog Scale (VAS) Pain Score. |
-31.76; -37.87; -48.57 | 0.05 |
Summary
Local administration of PLX-PAD single dose, intra-muscular injection for the regeneration of injured gluteal musculature after Total Hip Arthroplasty (THA).
Eligibility Criteria
Inclusion Criteria
- Male or female subjects between 50 to 75 years of age
- Scheduled THA
- ASA Score ≤ 3
- Signed written informed consent
Exclusion Criteria
- Muscle diseases
- Severe neurological diseases
- Opioid long term medication
- Pain chronification > stadium II of Gerbershagen
- Immunosuppression due to illness or medication
- Ankylosing spondylitis
- History of ectopic bone formation of any localisation
- Exclusion criteria for MRI (pace maker, defibrillator, ferromagnetic intracerebral clips)
- Uncontrolled hypertension (defined as diastolic blood pressure > 100 mmHg or systolic blood pressure > 200 mmHg during screening)
- Life-threatening ventricular arrhythmia or unstable angina - characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged
- 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)
- Subject has malignancy undergoing treatment including chemotherapy, radiotherapy or immunotherapy
- Body Mass Index (BMI) of 35 Kg/m2 or greater
- Known allergies to protein products (horse or bovine serum, or porcine trypsin) used in the cell production process
- Known HIV, syphilis at time of screening
- Known active Hepatitis B, or Hepatitis C infection at the time of screening
- 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)
- In the opinion of the investigator, the subject is unsuitable for cellular therapy
- 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)
- Subjects who are legally detained in an official institute
Data sourced from ClinicalTrials.gov (NCT01525667). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.