Hip FracturePhase 3NCT03451916
Treatment of Muscle Injury Following Arthroplasty for Hip Fracture (HF)
A Phase 3 study testing PLX-PAD in people with Hip Fracture, run by Pluristem Ltd. at 17 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 90 years
- Conditions the study is for
- Hip Fracture
- What is being tested?
- PLX-PAD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 17 sitesin 5 countries
- Study dates
- 26 Jul 2018to 6 Sep 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
Israel6 sites
Carmel Medical Center,7 Michal St
Haifa, 3436212
Shaare Zedek Medical Center,The Orthopedic Department,Shmu'el Bait St. 12
Jerusalem, 9103102
Meir Medical Center-Internal Medicine E;59 Tshernichovsky Street
Kfar Saba, 44281
The Chaim Sheba Medical Center,Tel Hashomer
Ramat Gan, 52621
Kaplan Medical Center,Pasternak St., P.O.B 1,Rehovot
Rehovot, 76100
Sourasky Medical Center,6 Weizmann St; Harrison Building 6 Floor
Tel Aviv, 64239
Bulgaria4 sites
MHAT "Ljulin" Department of Orthopedy and Traumatology
Sofia, 1303
MHAT "Serdika" Department of Orthopedy and Traumatology
Sofia, 1303
Military Medical Academy
Sofia, 1606
Specialized Hospital for Active Treatment in Orthopedy
Sofia, 1614
United States3 sites
Denver Metro Orthopedics, P.C. 499 E. Hampden Avenue, Suite 140 Englewood, CO 80113
Denver, Colorado, 80113
ANTRIA, INC,300 Indian Springs Road,Indiana
Indiana, Pennsylvania, 15701
University Of California Davis,4860 Y Street
Sacramento, California, 95817
Germany3 sites
Charite - Campus Mitte,Campus Virchow-Klinikum
Berlin, 10117
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden
Dresden, 01307
Universitaetsklinikum Muenster
Münster, 48149
About this study
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
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.
Read the 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.
- Conditions
- Hip Fracture
- Being tested
- PLX-PAD, Placebo
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLX-PADDrug
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
PlaceboDrug
Arm 2 Placebo (120 subjects): Placebo (solution comprised of 10% DMSO [v/v], 5% HSA [w/v], and PlasmaLyte, without cells).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery (SPPB) score
Measured: Week 26.
Secondary outcomes (3)
Hip abduction strength of the injured leg
Measured: Week 26.
Change from baseline to Week 52 in lower extremity measure (LEM) (retrospective collection of pre-fracture LEM at Day 5±1).
Measured: baseline to Week 52
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.
Measured: Week 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start26 Jul 2018
- Primary completion29 Apr 2022
- Study completion6 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pluristem Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451916
- Sponsor's protocol ID
- PLX-HF-01
- Status last verified
- Sep 2023
- First submitted
- 25 Feb 2018
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03451916
- Acronym / sponsor ID
- PLX-HF-01
- Conditions
- Hip Fracture
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Pluristem Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 6 Sep 2023 (actual)
- First posted
- 2 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| PLX-PAD | Experimental | Drug: 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. |
| Placebo | Placebo comparator | Drug: PlaceboArm 2 Placebo (120 subjects): Placebo (solution comprised of 10% DMSO [v/v], 5% HSA [w/v], and PlasmaLyte, without cells). |
Who may qualify
- Ages
- 0 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLX-PADPLX-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 |
| PlaceboArm 2 Placebo (120 subjects): Placebo (solution comprised of 10% DMSO [v/v], 5% HSA [w/v], and PlasmaLyte, without cells). | Drug | Placebo |
Primary outcome
Short Physical Performance Battery (SPPB) score
Time frame: Week 26.
3 secondary outcomes
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
SPPB score
Time frame: Week 52.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PLX-PAD in people with Hip Fracture, run by Pluristem Ltd. at 17 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Israel, Bulgaria, United States, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (SPPB) score (time frame: Week 26.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023; AzTrials last refreshed its copy on 8 Nov 2026.