EUCTR2011-003934-16-DE
Active, not recruiting
Not Applicable
A Phase I/II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Intramuscular Injections of Allogeneic PLX-PAD Cells for the Regeneration of Injured Gluteal Musculature after Total Hip Arthroplasty - PLX-PAD 1301-01
Pluristem Ltd.0 sites18 target enrollmentFebruary 14, 2012
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Pluristem Ltd.
- Enrollment
- 18
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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