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

NCT03451916 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: PLX-HF-01
• Study Type: interventional
• Target: 240
• Locations: 5 countries
• Sites: 17

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.

Conditions

Hip Fracture

Outcome Measures

Primary Outcomes (1)

• Short Physical Performance Battery (SPPB) score

  Week 26.

Secondary Outcomes (3)

• Hip abduction strength of the injured leg

  Week 26.

• Change from baseline to Week 52 in lower extremity measure (LEM) (retrospective collection of pre-fracture LEM at Day 5±1).

  baseline to Week 52

• SPPB score

  Week 52.

Study Arms (2)

PLX-PAD

EXPERIMENTAL

• 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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

PLX-PAD DRUG

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

PLX-PAD

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 0 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.
• \. Diabetes mellitus with HbA1c \>10% at Screening. 5. Known current or history of proliferative retinopathy or diabetic retinopathy.
• \. 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).
• \. 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).
• \. 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.
• \. 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).
• \. In the opinion of the Investigator, the subject is unsuitable for participating in the study.

Sponsors & Collaborators

• Pluristem Ltd.: lead

Study Sites (17)

University Of California Davis,4860 Y Street

Sacramento, California, 95817, United States

Location

Denver Metro Orthopedics, P.C. 499 E. Hampden Avenue, Suite 140 Englewood, CO 80113

Denver, Colorado, 80113, United States

Location

ANTRIA, INC,300 Indian Springs Road,Indiana

Indiana, Pennsylvania, 15701, United States

Location

MHAT "Ljulin" Department of Orthopedy and Traumatology

Sofia, 1303, Bulgaria

Location

MHAT "Serdika" Department of Orthopedy and Traumatology

Sofia, 1303, Bulgaria

Location

Military Medical Academy

Sofia, 1606, Bulgaria

Location

Specialized Hospital for Active Treatment in Orthopedy

Sofia, 1614, Bulgaria

Location

Charite - Campus Mitte,Campus Virchow-Klinikum

Berlin, 10117, Germany

Location

Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden

Dresden, 01307, Germany

Location

Universitaetsklinikum Muenster

Münster, 48149, Germany

Location

Carmel Medical Center,7 Michal St

Haifa, 3436212, Israel

Location

Shaare Zedek Medical Center,The Orthopedic Department,Shmu'el Bait St. 12

Jerusalem, 9103102, Israel

Location

Meir Medical Center-Internal Medicine E;59 Tshernichovsky Street

Kfar Saba, 44281, Israel

Location

The Chaim Sheba Medical Center,Tel Hashomer

Ramat Gan, 52621, Israel

Location

Kaplan Medical Center,Pasternak St., P.O.B 1,Rehovot

Rehovot, 76100, Israel

Location

Sourasky Medical Center,6 Weizmann St; Harrison Building 6 Floor

Tel Aviv, 64239, Israel

Location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: , subjects will be randomized using a 1:1 allocation scheme to either 150×10\^6 PLX-PAD cells or to placebo treatment, respectively

Study Record Dates

• First Submitted: February 25, 2018
• First Posted: March 2, 2018
• Study Start: July 26, 2018
• Primary Completion: April 29, 2022
• Study Completion: September 6, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); US (3); BU (4); DE (3); IL (6)