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

This study is currently recruiting participants.
Verified April 2013 by Pluristem Ltd.
Sponsor:
Information provided by (Responsible Party):
Pluristem Ltd.
ClinicalTrials.gov Identifier:
NCT01525667
First received: January 31, 2012
Last updated: April 18, 2013
Last verified: April 2013
History of Changes
  Purpose

Local administration of PLX-PAD single dose, intra-muscular injection for the regeneration of injured gluteal musculature after Total Hip Arthroplasty (THA).


Condition Intervention Phase
Total Hip Arthroplasty
Muscle Injury
 Biological: PLX-PAD low dose
Biological: PLX-PAD high dose
Biological: Placebo
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Pluristem Ltd.:

Primary Outcome Measures:
  • Primary Efficacy End-Point [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Function of the GM assessing maximal contraction force

  • Primary Safety End-Point [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ]
    Adverse Event, Laboratory Values, ECG Findings and Immunological Reaction


Secondary Outcome Measures:
  • Secondary Efficacy [ Time Frame: 12 and 26 weeks ] [ Designated as safety issue: No ]
    • Macrostructure of GM at week 12 and 26
    • Microstructure of GM at week 12

    • Clinical outcome at week 26:

      • Trendelenburg´s sign
      • Gait analysis
      • Harris Hip Score (HHS)
      • Quality of Life (SF36)
      • Oxford-12-Hip Score
      • Western Ontario and McMaster Universities' Arthritis-Index (WOMAC)
      • Pain assessment (VAS)


Estimated Enrollment: 18
Study Start Date: November 2012
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PLX-PAD low dose Biological: PLX-PAD low dose
Single treatment, multiple injections
Experimental: PLX-PAD high dose Biological: PLX-PAD high dose
Single treatment, multiple injections
Placebo Comparator: Placebo Biological: Placebo
Single treatment, multiple injections

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 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.

Subjects 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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subjects between 50 to 75 years of age
  2. Scheduled THA
  3. ASA Score ≤ 3
  4. Signed written informed consent

Exclusion Criteria:

  1. Muscle diseases
  2. Severe 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 of ectopic 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
  11. 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)
  12. Subject has malignancy undergoing treatment including chemotherapy, radiotherapy or immunotherapy
  13. Body Mass Index (BMI) of 35 Kg/m2 or greater
  14. Known allergies to protein products (horse or bovine serum, or porcine trypsin) used in the cell production process
  15. Known HIV, syphilis at time of screening
  16. Known active Hepatitis B, or Hepatitis C infection at the time of screening
  17. 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)
  18. In the opinion of the investigator, the subject is unsuitable for cellular therapy
  19. 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)
  20. Subjects who are legally detained in an official institute
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525667

Contacts
Contact: Carsten Perka, MD +49 30 450515110 carsten.perka@charite.de
Contact: Tobias Winkler, MD +49 30 450 615 109 tobias.winkler@charite.de

Locations
Germany
Charité Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Tobias Winkler, MD     +49 30 450 615 109        
Sub-Investigator: Tobias Winkler, MD            
Sub-Investigator: Philipp von Roth, MD            
Sub-Investigator: Bernd Preininger, MD            
Sub-Investigator: Eric Röhner, MD            
Sponsors and Collaborators
Pluristem Ltd.
Investigators
Principal Investigator: Carsten Perka, MD Charité Universitätsmedizin Berlin, Dept. Of Orthopedic Surgery, Charitéplatz 1, 10117 Berlin, Germany
  More Information

No publications provided

Responsible Party: Pluristem Ltd.
ClinicalTrials.gov Identifier: NCT01525667     History of Changes
Other Study ID Numbers: PLX-PAD 1301-01
Study First Received: January 31, 2012
Last Updated: April 18, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Pluristem Ltd.:
THA
Muscle injury

ClinicalTrials.gov processed this record on May 16, 2013