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PLX-PAD

Phase 3

Hip Fracture | Small molecule | Musculoskeletal |Pluri Inc.|Last Updated: Aug 30, 2024

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment240
FDA Designations
No designations recorded
Clinical trial landscape

PLX-PAD · 4 trials · 5 indications

Phase 3 2Phase 1 2
NCT03451916Treatment of Muscle Injury Following Arthroplasty for Hip Fracture (HF)Hip Fracture
COMPLETED240 Analytics
NCT03006770Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for RevascularizationCritical Limb Ischemia (CLI)
COMPLETED213 Analytics
PHASE3COMPLETED
Treatment of Muscle Injury Following Arthroplasty for Hip Fracture (HF)
Hip FractureUnlock trial analytics
PHASE3COMPLETED
Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization
Critical Limb Ischemia (CLI)Unlock trial analytics
Study Endpoints
Primary Endpoints
Short Physical Performance Battery (SPPB) score
Week 26.
Time to major amputation or death (AFS)
Up to 36 months from enrollment
Adverse events; Amputation incidence, Death incidence & Rehospitalization incidence
3 months
Immunological reaction
3 months
Adverse events, Safety laboratory values and ECG findings
3 months
Secondary Endpoints
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.
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PLX-PADEXPERIMENTAL• 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.
PlaceboPLACEBO_COMPARATORArm 2 Placebo (120 subjects): Placebo (solution comprised of 10% DMSO \[v/v\], 5% HSA \[w/v\], and PlasmaLyte, without cells).
PLX-PAD low doseEXPERIMENTALIM injection Single treatment; multiple injections
PLX-PAD high doseEXPERIMENTALIM injection Double treatment; multiple injections
PLX-PAD intermediate doseEXPERIMENTAL -
Interventions
NameTypeDescription
PLX-PADDRUGPLX-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
PlaceboDRUGArm 2 Placebo (120 subjects): Placebo (solution comprised of 10% DMSO \[v/v\], 5% HSA \[w/v\], and PlasmaLyte, without cells).
PLX-PAD IM injectionBIOLOGICALSingle treatment; multiple injections
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Eligibility Criteria
Age Range0 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites17

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 hou...

Countries:United StatesBulgariaGermanyIsraelUnited KingdomCzechiaHungaryNorth MacedoniaPoland
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Competitive Landscape -Fractures 35 trials (matched to "Hip Fracture")