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Treatment of Muscle Injury Following Arthroplasty for Hip Fracture (HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03451916
Recruitment Status : Recruiting
First Posted : March 2, 2018
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Pluristem Ltd.

Tracking Information
First Submitted Date  ICMJE February 25, 2018
First Posted Date  ICMJE March 2, 2018
Last Update Posted Date April 30, 2019
Actual Study Start Date  ICMJE July 26, 2018
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2018)
Short Physical Performance Battery (SPPB) score [ Time Frame: Week 26. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03451916 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2018)
  • Hip abduction strength of the injured leg [ Time Frame: Week 26. ]
  • Change from baseline to Week 52 in lower extremity measure (LEM) (retrospective collection of pre-fracture LEM at Day 5±1). [ Time Frame: baseline to Week 52 ]
  • Lean Body Mass of the injured leg at Week 26 (dual-energy x-ray absorptiometry [DEXA]). [ Time Frame: Week 26 ]
  • SPPB score [ Time Frame: Week 52. ]
    The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremities function. The SPPB consists of 3 types of physical maneuvers: balance test, speed gait test, and chair stand test. Results from each maneuvers test are scored on a scale of 0 to 4, with an increasing composite score indicating an improved lower extremities function level. The total maximum score of SPPB is 12.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2018)
  • Hip abduction strength of the injured leg [ Time Frame: Week 26. ]
  • Change from baseline to Week 52 in lower extremity measure (LEM) (retrospective collection of pre-fracture LEM at Day 5±1). [ Time Frame: baseline to Week 52 ]
  • Lean Body Mass of the injured leg at Week 26 (dual-energy x-ray absorptiometry [DEXA]). [ Time Frame: Week 26 ]
  • SPPB score [ Time Frame: Week 52. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Muscle Injury Following Arthroplasty for Hip Fracture (HF)
Official Title  ICMJE Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, Designed to Determine the Efficacy, Safety, and Tolerability of Intramuscular Administration of Allogeneic PLX-PAD Cells for the Treatment of Muscle Injury Following Arthroplasty for Hip Fracture
Brief Summary The objectives of this study are to assess the efficacy, safety, and tolerability of PLX-PAD intramuscular administration for the treatment of muscle injury following arthroplasty for HF.
Detailed Description

This will be a Phase III, multinational, randomized, double-blind, placebo-controlled study, assessing the efficacy, safety, and tolerability of intramuscular (IM) administration of allogeneic PLX-PAD cells for the treatment of muscle injury following arthroplasty for HF as compared to placebo treatment. Both treatment arms will receive standard of care treatment per local practice.

The study will comprise 2 periods:

  1. Main study period - from Screening to 52 weeks post-treatment. During this period, the subjects will have the following study visits: Screening, Day 0 (treatment and surgery day), Day 1, Day 5, Week 6, Week 12, Week 26 and Week 52.
  2. Safety follow-up period - from Week 52 to Week 104. During this safety follow-up period, there will be a phone call visit at Week 104, and only related serious adverse events (SAEs) and new malignancy adverse events will be collected.

The main study period will comprise 4 periods:

  1. Screening and pre-surgery time
  2. Surgery and treatment with PLX-PAD or placebo (Day 0)
  3. Hospital follow-up until Day 5±1, at least
  4. Follow-up period up to 52 weeks following study treatment administration. Subjects will be assessed for study eligibility before the emergency surgery for HF. After being found eligible, subjects will be randomized using a 1:1 allocation scheme to either 150×106 PLX-PAD cells or to placebo treatment, respectively. Within 48 hours of admission and up to 72 hours following fracture, subjects will undergo HA or THA. During the surgical procedure, the subjects will receive the investigational product in accordance with the treatment group to which they were randomized. Thereafter, visits will be conducted at Days 1 and 5±1, and at Weeks 6, 12, 26, 52 and 104.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
, subjects will be randomized using a 1:1 allocation scheme to either 150×106 PLX-PAD cells or to placebo treatment, respectively
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hip Fracture
Intervention  ICMJE
  • Drug: PLX-PAD
    PLX-PAD (120 subjects): 150×106 PLX-PAD cells (10×106 cells/mL) in a mixture containing 10% DMSO (v/v), 5% HSA (w/v) and PlasmaLyte
  • Drug: Placebo
    Arm 2 Placebo (120 subjects): Placebo (solution comprised of 10% DMSO [v/v], 5% HSA [w/v], and PlasmaLyte, without cells).
Study Arms  ICMJE
  • Experimental: PLX-PAD
    • Arm 1 - PLX-PAD (120 subjects): 150×10^6 PLX-PAD cells (10×10^6 cells/mL) in a mixture containing 10% DMSO (v/v), 5% HSA (w/v) and PlasmaLyte.
    Intervention: Drug: PLX-PAD
  • Placebo Comparator: Placebo
    Arm 2 Placebo (120 subjects): Placebo (solution comprised of 10% DMSO [v/v], 5% HSA [w/v], and PlasmaLyte, without cells).
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 25, 2018)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2021
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female subjects.
  2. Subjects 60 to 90 years of age
  3. Subjects suffering low energy trauma with intracapsular neck of femur fracture.
  4. Planned to be treated with total hip arthroplasty (THA) or hemi-arthroplasty (HA) within 48 hours of hospital admission and 72 hours post fracture.
  5. Subjects able to walk 10 feet/3 meters before the fracture.
  6. Signed an informed consent.

Exclusion Criteria:

  • 1. Any significant musculoskeletal, neurologic or neuromuscular disease causing muscle weakness and/or affecting mobility 2. Current fracture is due to bone pathology other than osteoporosis or due to major trauma 3. Planned orthopedic surgery on lower limbs (excluding hip arthroplasty) within the next 12 months.

    4. Diabetes mellitus with HbA1c >10% at Screening. 5. Known current or history of proliferative retinopathy or diabetic retinopathy.

    6. Known active Hepatitis B virus or Hepatitis C virus infection. 7. Known human immunodeficiency virus (HIV) infection 8. Subjects on renal replacement therapy or with estimated glomerular filtration rate (eGFR) <15 mL/min/1.73m2 9. Severe congestive heart failure symptoms (New York Heart Association [NYHA] Stage IV).

    10. Known uncontrolled severe hypertension. 11. Treatment with anabolic steroids within 6 months prior to study start 12. Active malignancy or history of malignancy within 3 years prior to study start 13. Known moderate to severe dementia or severe psychiatric disorder. 14. Known allergies to any of the following: dimethyl sulfoxide (DMSO), human serum albumin (HSA), bovine serum albumin, PlasmaLyte.

    15. History of allergic/hypersensitivity reaction to any substance having required hospitalization and/or treatment with IV steroids/epinephrine 16. Pulmonary disease requiring supplemental oxygen treatment on a daily basis. 17. life expectancy of less than 6 months, for reasons other than HF complications, 18. 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).

    19. In the opinion of the Investigator, the subject is unsuitable for participating in the study.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Denmark,   Germany,   Israel,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03451916
Other Study ID Numbers  ICMJE PLX-HF-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pluristem Ltd.
Study Sponsor  ICMJE Pluristem Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pluristem Ltd.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP