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

Primary Purpose

Hip Fracture

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PLX-PAD
Placebo
Sponsored by
Pluristem Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture

Eligibility Criteria

0 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female subjects
  2. Subjects up to 90 years of age, inclusive, at the time of Screening
  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, severe uncontrolled inflammatory disease or severe uncontrolled autoimmune disease (e.g., ulcerative colitis, Crohn's disease, etc).

    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.

Sites / Locations

  • University Of California Davis,4860 Y Street
  • Denver Metro Orthopedics, P.C. 499 E. Hampden Avenue, Suite 140 Englewood, CO 80113
  • ANTRIA, INC,300 Indian Springs Road,Indiana
  • MHAT "Ljulin" Department of Orthopedy and Traumatology
  • MHAT "Serdika" Department of Orthopedy and Traumatology
  • Military Medical Academy
  • Specialized Hospital for Active Treatment in Orthopedy
  • Charite - Campus Mitte,Campus Virchow-Klinikum
  • Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden
  • Universitaetsklinikum Muenster
  • Carmel Medical Center,7 Michal St
  • Shaare Zedek Medical Center,The Orthopedic Department,Shmu'el Bait St. 12
  • Meir Medical Center-Internal Medicine E;59 Tshernichovsky Street
  • The Chaim Sheba Medical Center,Tel Hashomer
  • Kaplan Medical Center,Pasternak St., P.O.B 1,Rehovot
  • Sourasky Medical Center,6 Weizmann St; Harrison Building 6 Floor
  • John Radcliffe Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PLX-PAD

Placebo

Arm Description

• 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.

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

Outcomes

Primary Outcome Measures

Short Physical Performance Battery (SPPB) score

Secondary Outcome Measures

Hip abduction strength of the injured leg
Change from baseline to Week 52 in lower extremity measure (LEM) (retrospective collection of pre-fracture LEM at Day 5±1).
SPPB score
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.

Full Information

First Posted
February 25, 2018
Last Updated
September 26, 2023
Sponsor
Pluristem Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03451916
Brief Title
Treatment of Muscle Injury Following Arthroplasty for Hip Fracture (HF)
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 26, 2018 (Actual)
Primary Completion Date
April 29, 2022 (Actual)
Study Completion Date
September 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pluristem Ltd.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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: 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. 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 survival and quality of life data, serious adverse events (SAEs) and new malignancy adverse events will be collected. The main study period will comprise 4 periods: Screening and pre-surgery time Surgery and treatment with PLX-PAD or placebo (Day 0) Hospital follow-up until Day 5±1, at least 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Model Description
, subjects will be randomized using a 1:1 allocation scheme to either 150×10^6 PLX-PAD cells or to placebo treatment, respectively
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PLX-PAD
Arm Type
Experimental
Arm Description
• 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Arm 2 Placebo (120 subjects): Placebo (solution comprised of 10% DMSO [v/v], 5% HSA [w/v], and PlasmaLyte, without cells).
Intervention Type
Drug
Intervention Name(s)
PLX-PAD
Intervention Description
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 Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Arm 2 Placebo (120 subjects): Placebo (solution comprised of 10% DMSO [v/v], 5% HSA [w/v], and PlasmaLyte, without cells).
Primary Outcome Measure Information:
Title
Short Physical Performance Battery (SPPB) score
Time Frame
Week 26.
Secondary Outcome Measure Information:
Title
Hip abduction strength of the injured leg
Time Frame
Week 26.
Title
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
Title
SPPB score
Description
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.
Time Frame
Week 52.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects Subjects up to 90 years of age, inclusive, at the time of Screening Subjects suffering low energy trauma with intracapsular neck of femur fracture. Planned to be treated with total hip arthroplasty (THA) or hemi-arthroplasty (HA) within 48 hours of hospital admission and 72 hours post fracture. Subjects able to walk 10 feet/3 meters before the fracture. 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, severe uncontrolled inflammatory disease or severe uncontrolled autoimmune disease (e.g., ulcerative colitis, Crohn's disease, etc). 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.
Facility Information:
Facility Name
University Of California Davis,4860 Y Street
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Denver Metro Orthopedics, P.C. 499 E. Hampden Avenue, Suite 140 Englewood, CO 80113
City
Denver
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
ANTRIA, INC,300 Indian Springs Road,Indiana
City
Indiana
State/Province
Pennsylvania
ZIP/Postal Code
15701
Country
United States
Facility Name
MHAT "Ljulin" Department of Orthopedy and Traumatology
City
Sofia
ZIP/Postal Code
1303
Country
Bulgaria
Facility Name
MHAT "Serdika" Department of Orthopedy and Traumatology
City
Sofia
ZIP/Postal Code
1303
Country
Bulgaria
Facility Name
Military Medical Academy
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment in Orthopedy
City
Sofia
ZIP/Postal Code
1614
Country
Bulgaria
Facility Name
Charite - Campus Mitte,Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitaetsklinikum Muenster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Carmel Medical Center,7 Michal St
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Shaare Zedek Medical Center,The Orthopedic Department,Shmu'el Bait St. 12
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Meir Medical Center-Internal Medicine E;59 Tshernichovsky Street
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
The Chaim Sheba Medical Center,Tel Hashomer
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Kaplan Medical Center,Pasternak St., P.O.B 1,Rehovot
City
Reẖovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Sourasky Medical Center,6 Weizmann St; Harrison Building 6 Floor
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
John Radcliffe Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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