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

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ClinicalTrials.gov Identifier: NCT03451916
Recruitment Status : Recruiting
First Posted : March 2, 2018
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Pluristem Ltd.

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.

Condition or disease Intervention/treatment Phase
Hip Fracture Drug: PLX-PAD Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
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
Official Title: 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
Actual Study Start Date : July 26, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: PlasmaLyte

Arm Intervention/treatment
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.
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

Placebo Comparator: Placebo
Arm 2 Placebo (120 subjects): Placebo (solution comprised of 10% DMSO [v/v], 5% HSA [w/v], and PlasmaLyte, without cells).
Drug: Placebo
Arm 2 Placebo (120 subjects): Placebo (solution comprised of 10% DMSO [v/v], 5% HSA [w/v], and PlasmaLyte, without cells).




Primary Outcome Measures :
  1. Short Physical Performance Battery (SPPB) score [ Time Frame: Week 26. ]

Secondary Outcome Measures :
  1. Hip abduction strength of the injured leg [ Time Frame: Week 26. ]
  2. 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 ]
  3. Lean Body Mass of the injured leg at Week 26 (dual-energy x-ray absorptiometry [DEXA]). [ Time Frame: Week 26 ]
  4. 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.



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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451916


Locations
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United States, California
University Of California Davis,4860 Y Street Recruiting
Sacramento, California, United States, 95817
Contact: Mark A Lee, Dr.    916-734-2729    marlee@ucdavis.edu   
Principal Investigator: Mark A Lee, Dr.         
United States, Colorado
Denver Metro Orthopedics, P.C. 499 E. Hampden Avenue, Suite 140 Englewood, CO 80113 Recruiting
Denver, Colorado, United States, 80113
Contact: John Schwappach, Dr    303-789-3000    schwappach@dmortho.com   
Principal Investigator: John Schwappach, Dr         
United States, Connecticut
Center for Musculoskeletal Care, Yale New Haven Hospital St. Raphael Campus,659 George Street Recruiting
New Haven, Connecticut, United States, 06511
Contact: Mary O'Connor, Dr.    904-607-8348    mary.oconnor@yale.edu   
Principal Investigator: Mary O'Connor, Dr.         
United States, Maryland
Sinai Hospital - Rubin Institute for Advanced Orthopedics (RIAO) - Center for Joint Preservation and Replacement,Baltimore,2401 W Belvedere Ave Fl 5 Recruiting
Baltimore, Maryland, United States, 21215-5216
Contact: James Nace, Dr    410-601-8500    jnace@lifebridgehealth.org   
Principal Investigator: James Nace, Dr         
United States, Pennsylvania
ANTRIA, INC,300 Indian Springs Road,Indiana Recruiting
Indiana, Pennsylvania, United States, 15701
Contact: David Bizousky, Dr.    724-349-0520    DBIZOUSKY@ANTRIA.ORG   
Principal Investigator: David Bizousky, Dr.         
Denmark
Odense Universitetshospital,Sdr. Boulevard 29,Odense C Recruiting
Odense, Denmark, 5000
Contact: Hagen Schmal, Dr.    +45 29428705    hagen.schmal@rsyd.dk   
Principal Investigator: Hagen Schmal, Dr.         
Israel
Soroka University Medical Center,Rager Blvd. 1 Yitzhack Rager Boulevard ,Beer Sheva Recruiting
Be'er Sheva, Israel, 8410101
Contact: Vadim Benkovich, Dr    972-8-6271922    vbenkovich@yahoo.com   
Principal Investigator: Vadim Benkovich, Dr.         
Carmel Medical Center,7 Michal St Recruiting
Haifa, Israel, 3436212
Contact: Benjamin Bernfeld, Dr.    +972-544988926    bernfeld_benny@clalit.org.il   
Principal Investigator: Benjamin Bernfeld, Dr.         
Shaare Zedek Medical Center,The Orthopedic Department,Shmu'el Bait St. 12 Recruiting
Jerusalem, Israel, 9103102
Contact: Michael Toybenshlak, Dr.    +972-2-6555566    michaelt@szmc.org.il   
Principal Investigator: Michael Toybenshlak, Dr.         
Meir Medical Center-Internal Medicine E;59 Tshernichovsky Street Recruiting
Kfar-Saba, Israel, 44281
Contact: Yaron Brin, Dr.    +972-9-7471746    yaronbrin@gmail.com   
Principal Investigator: Yaron Brin, Dr.         
Rabin Medical Center,36 Jabutinsky St. Recruiting
Petah tikva, Israel
Contact: Snir Heller, Dr.    +972-3-9376158    snirh@clalit.org.il   
Principal Investigator: Snir Heller, Dr.         
The Chaim Sheba Medical Center,Tel Hashomer Recruiting
Ramat Gan, Israel, 52621
Contact: Eran Avivi, Dr.    +972-3-5302417    eran.avivi@sheba.health.gov.il   
Principal Investigator: Eran Avivi, Dr.         
Kaplan Medical Center,Pasternak St., P.O.B 1,Rehovot Recruiting
Reẖovot, Israel, 76100
Contact: Yona Kosashvili, Prof    1 972523277422    Yonako1@clalit.org.il   
Principal Investigator: Yona Kosashvili, Prof         
Sourasky Medical Center,6 Weizmann St; Harrison Building 6 Floor Recruiting
Tel Aviv, Israel, 64239
Contact: Moshe Salai, Prof.    97236974720    moshesa@tlvmc.gov.il   
Principal Investigator: Moshe Salai, Prof.         
Sponsors and Collaborators
Pluristem Ltd.

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Responsible Party: Pluristem Ltd.
ClinicalTrials.gov Identifier: NCT03451916     History of Changes
Other Study ID Numbers: PLX-HF-01
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Plasma-lyte 148
Ophthalmic Solutions
Pharmaceutical Solutions