Status:
COMPLETED
Safety and Efficacy of IM Injections of PLX-PAD for the Regeneration of Injured Gluteal Musculature After Total Hip Arthroplasty
Lead Sponsor:
Pluristem Ltd.
Conditions:
Total Hip Arthroplasty
Muscle Injury
Eligibility:
All Genders
50-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Local administration of PLX-PAD single dose, intra-muscular injection for the regeneration of injured gluteal musculature after Total Hip Arthroplasty (THA).
Detailed Description
One of the main problems when performing THA via the standard transgluteal approach is the necessary injury of the gluteus medius muscle. The consecutive decrease of contractile muscle substance and t...
Eligibility Criteria
Inclusion
- Male or female subjects between 50 to 75 years of age
- Scheduled THA
- ASA Score ≤ 3
- Signed written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01525667
Start Date
November 1 2012
End Date
June 1 2015
Last Update
September 21 2015
Active Locations (1)
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1
Charité Universitätsmedizin Berlin
Berlin, State of Berlin, Germany, 10117