Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT01525667
Status:
COMPLETED
Last Update Posted:
2015-09-21
First Post:
2012-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of IM Injections of PLX-PAD for the Regeneration of Injured Gluteal Musculature After Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'estherl@Pluristem.com', 'phone': '+972-972-74-710-8600', 'title': 'Dr.Esther Lukasiewicz Hagai', 'phoneExt': '694', 'organization': 'Pluristem Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Data were collected for total period of 1 year.', 'eventGroups': [{'id': 'EG000', 'title': '150M PLX-PAD', 'description': 'PLX-PAD low dose: Single treatment, multiple injections', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '300M PLX-PAD', 'description': 'PLX-PAD high dose: Single treatment, multiple injections', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo: Single treatment, multiple injections', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Breath odour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Anaemia postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Post procedural swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Suture related complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Procedural hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications'}], 'seriousEvents': [{'term': 'HUMERAL HEAD FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'PERIURETHRAL CYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Day 0 to Week 26 in the Maximal Voluntary Isometric Contraction (MVIC) Moment of the Injured Side to Assess Gluteus Medius Strength.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PLX-PAD Low Dose', 'description': 'PLX-PAD low dose: Single treatment, multiple injections'}, {'id': 'OG001', 'title': 'PLX-PAD High Dose', 'description': 'PLX-PAD high dose: Single treatment, multiple injections'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: Single treatment, multiple injections'}], 'classes': [{'categories': [{'measurements': [{'value': '31.17', 'spread': '6.97', 'groupId': 'OG000'}, {'value': '20.36', 'spread': '7.61', 'groupId': 'OG001'}, {'value': '5.43', 'spread': '6.46', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0067', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Square Means (LSM) Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.74', 'ciLowerLimit': '7.61', 'ciUpperLimit': '43.86', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.94', 'estimateComment': 'LSM difference =LSM Low dose - LSM Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.18', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Square Means (LSM) difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.93', 'ciLowerLimit': '-7.12', 'ciUpperLimit': '36.99', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.80', 'estimateComment': 'LSM difference= LSM High Dose - LSM Placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 0 to Week 26', 'description': 'Change from Visit 2 (Day 0) to Week 26 in the maximal voluntary isometric contraction (MVIC) moment of the injured side as measured by isometric dynamometry to assess Gluteus Medius force strength.', 'unitOfMeasure': 'Newtons', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Day 0 to Week 26 in Muscle Volume.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '150M PLX-PAD', 'description': 'PLX-PAD low dose: Single treatment, multiple injections'}, {'id': 'OG001', 'title': '300M PLX-PAD', 'description': 'PLX-PAD high dose: Single treatment, multiple injections'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: Single treatment, multiple injections'}], 'classes': [{'categories': [{'measurements': [{'value': '24.42', 'spread': '4.18', 'groupId': 'OG000'}, {'value': '15.62', 'spread': '4.91', 'groupId': 'OG001'}, {'value': '6.39', 'spread': '4.35', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.03', 'ciLowerLimit': '6.03', 'ciUpperLimit': '30.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.97', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.19', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.23', 'ciLowerLimit': '-4.72', 'ciUpperLimit': '23.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.91', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 0 to Week 26', 'description': 'Change from Visit 2 (Day 0) to Week 26 in Muscle Volume as Measured by MRI.', 'unitOfMeasure': 'mm3', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Day 1 to Week 12 in Mean Fiber Diameter.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '150M PLX-PAD', 'description': 'PLX-PAD low dose: Single treatment, multiple injections'}, {'id': 'OG001', 'title': '300M PLX-PAD', 'description': 'PLX-PAD high dose: Single treatment, multiple injections'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: Single treatment, multiple injections'}], 'classes': [{'categories': [{'measurements': [{'value': '1.25', 'spread': '3.27', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '3.23', 'groupId': 'OG001'}, {'value': '-5.21', 'spread': '3.24', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.19', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.45', 'ciLowerLimit': '-3.50', 'ciUpperLimit': '16.41', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.64', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.25', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.49', 'ciLowerLimit': '-4.29', 'ciUpperLimit': '15.26', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.56', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 to Week 12', 'description': 'Change from Visit 3 (Day 1) to Week 12 in Mean Fiber Diameter as Measured by Muscle Biopsy.', 'unitOfMeasure': 'microns', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Day 0 to Week 26 in the Ratio of Injured to Contralateral Pelvic Shift .', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '150M PLX-PAD', 'description': 'PLX-PAD low dose: Single treatment, multiple injections'}, {'id': 'OG001', 'title': '300M PLX-PAD', 'description': 'PLX-PAD high dose: Single treatment, multiple injections'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: Single treatment, multiple injections'}], 'classes': [{'categories': [{'measurements': [{'value': '0.43', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '0.27', 'spread': '0.13', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.53', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.96', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.011', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.20', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 0 to Week 26', 'description': 'Change from Visit 2 (Day 0) to Week 26 in the Ratio of Injured to Contralateral Pelvic Shift as Measured by Gait Analysis', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Day 0 to Week 26 in the Visual Analog Scale (VAS) Pain Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '150M PLX-PAD', 'description': 'PLX-PAD low dose: Single treatment, multiple injections'}, {'id': 'OG001', 'title': '300M PLX-PAD', 'description': 'PLX-PAD high dose: Single treatment, multiple injections'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: Single treatment, multiple injections'}], 'classes': [{'categories': [{'measurements': [{'value': '-31.76', 'spread': '5.90', 'groupId': 'OG000'}, {'value': '-37.87', 'spread': '6.53', 'groupId': 'OG001'}, {'value': '-48.57', 'spread': '5.97', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.81', 'ciLowerLimit': '0.16', 'ciUpperLimit': '33.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.37', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.24', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.70', 'ciLowerLimit': '-7.26', 'ciUpperLimit': '28.65', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.01', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 0 to Week 26', 'description': 'Visual Analog Scale (VAS) Pain Score ranges from 0 mm (no pain) to 100 mm (worse possible pain)', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PLX-PAD Low Dose', 'description': '150M PLX-PAD : Single treatment, multiple injections'}, {'id': 'FG001', 'title': 'PLX-PAD High Dose', 'description': '300M PLX-PAD : Single treatment, multiple injections'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo: Single treatment, multiple injections'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'PLX-PAD Low Dose', 'description': 'PLX-PAD low dose: Single treatment, multiple injections'}, {'id': 'BG001', 'title': 'PLX-PAD High Dose', 'description': 'PLX-PAD high dose: Single treatment, multiple injections'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo: Single treatment, multiple injections'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.4', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '64.5', 'spread': '7.4', 'groupId': 'BG001'}, {'value': '64.3', 'spread': '6.4', 'groupId': 'BG002'}, {'value': '64.8', 'spread': '6.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-07', 'studyFirstSubmitDate': '2012-01-31', 'resultsFirstSubmitDate': '2015-01-01', 'studyFirstSubmitQcDate': '2012-02-02', 'lastUpdatePostDateStruct': {'date': '2015-09-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-05', 'studyFirstPostDateStruct': {'date': '2012-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Day 0 to Week 26 in the Maximal Voluntary Isometric Contraction (MVIC) Moment of the Injured Side to Assess Gluteus Medius Strength.', 'timeFrame': 'Day 0 to Week 26', 'description': 'Change from Visit 2 (Day 0) to Week 26 in the maximal voluntary isometric contraction (MVIC) moment of the injured side as measured by isometric dynamometry to assess Gluteus Medius force strength.'}], 'secondaryOutcomes': [{'measure': 'Change From Day 0 to Week 26 in Muscle Volume.', 'timeFrame': 'Day 0 to Week 26', 'description': 'Change from Visit 2 (Day 0) to Week 26 in Muscle Volume as Measured by MRI.'}, {'measure': 'Change From Day 1 to Week 12 in Mean Fiber Diameter.', 'timeFrame': 'Day 1 to Week 12', 'description': 'Change from Visit 3 (Day 1) to Week 12 in Mean Fiber Diameter as Measured by Muscle Biopsy.'}, {'measure': 'Change From Day 0 to Week 26 in the Ratio of Injured to Contralateral Pelvic Shift .', 'timeFrame': 'Day 0 to Week 26', 'description': 'Change from Visit 2 (Day 0) to Week 26 in the Ratio of Injured to Contralateral Pelvic Shift as Measured by Gait Analysis'}, {'measure': 'Change From Day 0 to Week 26 in the Visual Analog Scale (VAS) Pain Score.', 'timeFrame': 'Day 0 to Week 26', 'description': 'Visual Analog Scale (VAS) Pain Score ranges from 0 mm (no pain) to 100 mm (worse possible pain)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['THA', 'Muscle injury'], 'conditions': ['Total Hip Arthroplasty', 'Muscle Injury']}, 'descriptionModule': {'briefSummary': 'Local administration of PLX-PAD single dose, intra-muscular injection for the regeneration of injured gluteal musculature after Total Hip Arthroplasty (THA).', 'detailedDescription': '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 the substitution by scar tissue leads to functional deficits of the pelvic-stabilizing musculature with an insufficiency limp in a large number of patients. In the long run the lack of musculature leads to a decrease in bone substance at the insertion sites of the gluteal muscles of the proximal femur. The present study has the aim of establishing a new therapy for iatrogenic gluteal muscle damage. The hypothesis of the present proposal is that intra-muscular (IM) injection of PLX-PAD into the iatrogenically injured gluteus medius muscle after THA results in an improved regeneration of the skeletal muscle tissue and consecutively in an improved functional outcome.\n\nSubjects will be assigned to receive one of the two targeted doses of PLX-PAD or placebo. On the treatment day, after suturing the gluteus medius muscle PLX-PAD or placebo will be applied directly to the site of laceration.\n\nPatients will be followed up for efficacy assessment up to week 26 and for safety assessment (Adverse events, vital signs, ECG, routinf lab and immunological testing) up to week 52 after THA. Patients will be phoned at week 104 in order to inquire about the occurence of new cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female subjects between 50 to 75 years of age\n2. Scheduled THA\n3. ASA Score ≤ 3\n4. Signed written informed consent\n\nExclusion Criteria:\n\n1. Muscle diseases\n2. Severe neurological diseases\n3. Opioid long term medication\n4. Pain chronification \\> stadium II of Gerbershagen\n5. Immunosuppression due to illness or medication\n6. Ankylosing spondylitis\n7. History of ectopic bone formation of any localisation\n8. Exclusion criteria for MRI (pace maker, defibrillator, ferromagnetic intracerebral clips)\n9. Uncontrolled hypertension (defined as diastolic blood pressure \\> 100 mmHg or systolic blood pressure \\> 200 mmHg during screening)\n10. Life-threatening ventricular arrhythmia or unstable angina - characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged\n11. 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)\n12. Subject has malignancy undergoing treatment including chemotherapy, radiotherapy or immunotherapy\n13. Body Mass Index (BMI) of 35 Kg/m2 or greater\n14. Known allergies to protein products (horse or bovine serum, or porcine trypsin) used in the cell production process\n15. Known HIV, syphilis at time of screening\n16. Known active Hepatitis B, or Hepatitis C infection at the time of screening\n17. 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)\n18. In the opinion of the investigator, the subject is unsuitable for cellular therapy\n19. 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)\n20. Subjects who are legally detained in an official institute'}, 'identificationModule': {'nctId': 'NCT01525667', 'briefTitle': 'Safety and Efficacy of IM Injections of PLX-PAD for the Regeneration of Injured Gluteal Musculature After Total Hip Arthroplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pluristem Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'PLX-PAD 1301-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '150M PLX-PAD', 'description': 'Single course, multiple IM injections', 'interventionNames': ['Biological: 150M PLX-PAD']}, {'type': 'EXPERIMENTAL', 'label': '300M PLX-PAD', 'description': 'Single course, multiple IM injections', 'interventionNames': ['Biological: 300M PLX-PAD']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Single course, multiple IM injections', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': '150M PLX-PAD', 'type': 'BIOLOGICAL', 'description': 'Single course, multiple IM injections', 'armGroupLabels': ['150M PLX-PAD']}, {'name': '300M PLX-PAD', 'type': 'BIOLOGICAL', 'description': 'Single course, multiple IM injections', 'armGroupLabels': ['300M PLX-PAD']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Single course, multiple IM injections', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Charité Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Carsten Perka, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité Universitätsmedizin Berlin, Dept. Of Orthopedic Surgery, Charitéplatz 1, 10117 Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pluristem Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}