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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

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:

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.

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

NCT ID

NCT03451916

First Posted

February 25, 2018

Last Updated

September 26, 2023

Sponsor

Pluristem Ltd.

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

Product Manufactured in and Exported from the U.S.

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

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

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

Learn more about this trial

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

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