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Safety and Efficacy of IM Injections of PLX-PAD for the Regeneration of Injured Gluteal Musculature After Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT01525667
Recruitment Status : Completed
First Posted : February 3, 2012
Results First Posted : February 23, 2015
Last Update Posted : September 21, 2015
Sponsor:
Information provided by (Responsible Party):
Pluristem Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Total Hip Arthroplasty
Muscle Injury
Interventions Biological: 150M PLX-PAD
Biological: 300M PLX-PAD
Biological: Placebo
Enrollment 20

Recruitment Details  
Pre-assignment Details  
Arm/Group Title PLX-PAD Low Dose PLX-PAD High Dose Placebo
Hide Arm/Group Description 150M PLX-PAD : Single treatment, multiple injections 300M PLX-PAD : Single treatment, multiple injections Placebo: Single treatment, multiple injections
Period Title: Overall Study
Started 7 6 7
Completed 7 6 7
Not Completed 0 0 0
Arm/Group Title PLX-PAD Low Dose PLX-PAD High Dose Placebo Total
Hide Arm/Group Description PLX-PAD low dose: Single treatment, multiple injections PLX-PAD high dose: Single treatment, multiple injections Placebo: Single treatment, multiple injections Total of all reporting groups
Overall Number of Baseline Participants 7 6 7 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 7 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  42.9%
2
  33.3%
4
  57.1%
9
  45.0%
>=65 years
4
  57.1%
4
  66.7%
3
  42.9%
11
  55.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 6 participants 7 participants 20 participants
65.4  (5.9) 64.5  (7.4) 64.3  (6.4) 64.8  (6.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 7 participants 20 participants
Female
3
  42.9%
1
  16.7%
6
  85.7%
10
  50.0%
Male
4
  57.1%
5
  83.3%
1
  14.3%
10
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 7 participants 6 participants 7 participants 20 participants
7 6 7 20
1.Primary Outcome
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.
Hide 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.
Time Frame Day 0 to Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PLX-PAD Low Dose PLX-PAD High Dose Placebo
Hide Arm/Group Description:
PLX-PAD low dose: Single treatment, multiple injections
PLX-PAD high dose: Single treatment, multiple injections
Placebo: Single treatment, multiple injections
Overall Number of Participants Analyzed 7 6 7
Least Squares Mean (Standard Error)
Unit of Measure: Newtons
31.17  (6.97) 20.36  (7.61) 5.43  (6.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PLX-PAD Low Dose, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0067
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Means (LSM) Difference
Estimated Value 25.74
Confidence Interval (2-Sided) 95%
7.61 to 43.86
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.94
Estimation Comments LSM difference =LSM Low dose - LSM Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PLX-PAD High Dose, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Means (LSM) difference
Estimated Value 14.93
Confidence Interval (2-Sided) 95%
-7.12 to 36.99
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.80
Estimation Comments LSM difference= LSM High Dose - LSM Placebo
2.Secondary Outcome
Title Change From Day 0 to Week 26 in Muscle Volume.
Hide Description Change from Visit 2 (Day 0) to Week 26 in Muscle Volume as Measured by MRI.
Time Frame Day 0 to Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 150M PLX-PAD 300M PLX-PAD Placebo
Hide Arm/Group Description:
PLX-PAD low dose: Single treatment, multiple injections
PLX-PAD high dose: Single treatment, multiple injections
Placebo: Single treatment, multiple injections
Overall Number of Participants Analyzed 7 6 7
Least Squares Mean (Standard Error)
Unit of Measure: mm3
24.42  (4.18) 15.62  (4.91) 6.39  (4.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 150M PLX-PAD, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM Difference
Estimated Value 18.03
Confidence Interval (2-Sided) 95%
6.03 to 30.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.97
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 300M PLX-PAD, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM difference
Estimated Value 9.23
Confidence Interval (2-Sided) 95%
-4.72 to 23.17
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.91
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Day 1 to Week 12 in Mean Fiber Diameter.
Hide Description Change from Visit 3 (Day 1) to Week 12 in Mean Fiber Diameter as Measured by Muscle Biopsy.
Time Frame Day 1 to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 150M PLX-PAD 300M PLX-PAD Placebo
Hide Arm/Group Description:
PLX-PAD low dose: Single treatment, multiple injections
PLX-PAD high dose: Single treatment, multiple injections
Placebo: Single treatment, multiple injections
Overall Number of Participants Analyzed 7 6 7
Least Squares Mean (Standard Error)
Unit of Measure: microns
1.25  (3.27) 0.28  (3.23) -5.21  (3.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 150M PLX-PAD, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM Difference
Estimated Value 6.45
Confidence Interval (2-Sided) 95%
-3.50 to 16.41
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.64
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 300M PLX-PAD, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM difference
Estimated Value 5.49
Confidence Interval (2-Sided) 95%
-4.29 to 15.26
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.56
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Day 0 to Week 26 in the Ratio of Injured to Contralateral Pelvic Shift .
Hide Description Change from Visit 2 (Day 0) to Week 26 in the Ratio of Injured to Contralateral Pelvic Shift as Measured by Gait Analysis
Time Frame Day 0 to Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 150M PLX-PAD 300M PLX-PAD Placebo
Hide Arm/Group Description:
PLX-PAD low dose: Single treatment, multiple injections
PLX-PAD high dose: Single treatment, multiple injections
Placebo: Single treatment, multiple injections
Overall Number of Participants Analyzed 7 6 7
Least Squares Mean (Standard Error)
Unit of Measure: Ratio
0.43  (0.13) 0.28  (0.14) 0.27  (0.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 150M PLX-PAD, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
-0.21 to 0.53
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.19
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 300M PLX-PAD, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.011
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.20
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Day 0 to Week 26 in the Visual Analog Scale (VAS) Pain Score.
Hide Description Visual Analog Scale (VAS) Pain Score ranges from 0 mm (no pain) to 100 mm (worse possible pain)
Time Frame Day 0 to Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 150M PLX-PAD 300M PLX-PAD Placebo
Hide Arm/Group Description:
PLX-PAD low dose: Single treatment, multiple injections
PLX-PAD high dose: Single treatment, multiple injections
Placebo: Single treatment, multiple injections
Overall Number of Participants Analyzed 7 6 7
Least Squares Mean (Standard Error)
Unit of Measure: mm
-31.76  (5.90) -37.87  (6.53) -48.57  (5.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 150M PLX-PAD, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM difference
Estimated Value 16.81
Confidence Interval (2-Sided) 95%
0.16 to 33.47
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.37
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 300M PLX-PAD, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM difference
Estimated Value 10.70
Confidence Interval (2-Sided) 95%
-7.26 to 28.65
Parameter Dispersion
Type: Standard Error of the mean
Value: 9.01
Estimation Comments [Not Specified]
Time Frame Data were collected for total period of 1 year.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 150M PLX-PAD 300M PLX-PAD Placebo
Hide Arm/Group Description PLX-PAD low dose: Single treatment, multiple injections PLX-PAD high dose: Single treatment, multiple injections Placebo: Single treatment, multiple injections
All-Cause Mortality
150M PLX-PAD 300M PLX-PAD Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
150M PLX-PAD 300M PLX-PAD Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/7 (14.29%)      0/6 (0.00%)      1/7 (14.29%)    
Musculoskeletal and connective tissue disorders       
HUMERAL HEAD FRACTURE  1/7 (14.29%)  1 0/6 (0.00%)  0 1/7 (14.29%)  1
Renal and urinary disorders       
PERIURETHRAL CYST  0/7 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
150M PLX-PAD 300M PLX-PAD Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/7 (100.00%)      6/6 (100.00%)      7/7 (100.00%)    
Gastrointestinal disorders       
Nausea  1/7 (14.29%)  1 1/6 (16.67%)  1 2/7 (28.57%)  2
Injury, poisoning and procedural complications       
Procedural pain  5/7 (71.43%)  7 3/6 (50.00%)  3 3/7 (42.86%)  4
Anaemia postoperative  1/7 (14.29%)  1 0/6 (0.00%)  0 3/7 (42.86%)  3
Post procedural swelling  3/7 (42.86%)  3 3/6 (50.00%)  4 2/7 (28.57%)  4
Suture related complication  2/7 (28.57%)  2 0/6 (0.00%)  0 0/7 (0.00%)  0
Procedural hypotension  2/7 (28.57%)  3 1/6 (16.67%)  1 2/7 (28.57%)  2
Musculoskeletal and connective tissue disorders       
Arthralgia  0/7 (0.00%)  0 1/6 (16.67%)  2 1/7 (14.29%)  1
Muscle spasms  2/7 (28.57%)  3 1/6 (16.67%)  1 0/7 (0.00%)  0
Nervous system disorders       
Paraesthesia  2/7 (28.57%)  3 0/6 (0.00%)  0 1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders       
Breath odour  2/7 (28.57%)  2 1/6 (16.67%)  1 1/7 (14.29%)  1
Nasopharyngitis  0/7 (0.00%)  0 2/6 (33.33%)  2 2/7 (28.57%)  2
Skin and subcutaneous tissue disorders       
Alopecia  0/7 (0.00%)  0 0/6 (0.00%)  0 2/7 (28.57%)  2
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr.Esther Lukasiewicz Hagai
Organization: Pluristem Ltd.
Phone: +972-972-74-710-8600 ext 694
Responsible Party: Pluristem Ltd.
ClinicalTrials.gov Identifier: NCT01525667     History of Changes
Other Study ID Numbers: PLX-PAD 1301-01
First Submitted: January 31, 2012
First Posted: February 3, 2012
Results First Submitted: January 1, 2015
Results First Posted: February 23, 2015
Last Update Posted: September 21, 2015