NCT01525667

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2012

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 3, 2012

Completed
9 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 23, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 21, 2015

Status Verified

January 1, 2015

Enrollment Period

1.1 years

First QC Date

January 31, 2012

Results QC Date

January 1, 2015

Last Update Submit

September 7, 2015

Conditions

Total Hip ArthroplastyMuscle Injury

Keywords

THAMuscle injury

Outcome Measures

Primary Outcomes (1)

  • Change From Day 0 to Week 26 in the Maximal Voluntary Isometric Contraction (MVIC) Moment of the Injured Side to Assess Gluteus Medius Strength.

    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.

    Day 0 to Week 26

Secondary Outcomes (4)

  • Change From Day 0 to Week 26 in Muscle Volume.

    Day 0 to Week 26

  • Change From Day 1 to Week 12 in Mean Fiber Diameter.

    Day 1 to Week 12

  • Change From Day 0 to Week 26 in the Ratio of Injured to Contralateral Pelvic Shift .

    Day 0 to Week 26

  • Change From Day 0 to Week 26 in the Visual Analog Scale (VAS) Pain Score.

    Day 0 to Week 26

Study Arms (3)

150M PLX-PAD

EXPERIMENTAL

Single course, multiple IM injections

Biological: 150M PLX-PAD

300M PLX-PAD

EXPERIMENTAL

Single course, multiple IM injections

Biological: 300M PLX-PAD

Placebo

PLACEBO COMPARATOR

Single course, multiple IM injections

Biological: Placebo

Interventions

150M PLX-PADBIOLOGICAL

Single course, multiple IM injections

150M PLX-PAD
300M PLX-PADBIOLOGICAL

Single course, multiple IM injections

300M PLX-PAD
PlaceboBIOLOGICAL

Single course, multiple IM injections

Placebo

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Location

Results Point of Contact

Title
Dr.Esther Lukasiewicz Hagai
Organization
Pluristem Ltd.
estherl@Pluristem.com
+972-972-74-710-8600

Study Officials

  • Carsten Perka, MD

    Charité Universitätsmedizin Berlin, Dept. Of Orthopedic Surgery, Charitéplatz 1, 10117 Berlin, Germany

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2012

First Posted

February 3, 2012

Study Start

November 1, 2012

Primary Completion

December 1, 2013

Study Completion

June 1, 2015

Last Updated

September 21, 2015

Results First Posted

February 23, 2015

Record last verified: 2015-01

Locations

DE(1)