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150M PLX-PAD

Phase 1

Total Hip Arthroplasty | Monoclonal antibody | Other |Pluri Inc.|Last Updated: Sep 21, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

150M PLX-PAD · 1 trial · 2 indications

Phase 1 1
NCT01525667Safety and Efficacy of IM Injections of PLX-PAD for the Regeneration of Injured Gluteal Musculature After Total Hip ArthroplastyTotal Hip Arthroplasty
COMPLETED20 Analytics
PHASE1COMPLETED
Safety and Efficacy of IM Injections of PLX-PAD for the Regeneration of Injured Gluteal Musculature After Total Hip Arthroplasty
Total Hip ArthroplastyUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Day 0 to Week 26 in the Maximal Voluntary Isometric Contraction (MVIC) Moment of the Injured Side to Assess Gluteus Medius Strength.
Day 0 to Week 26

Change from Visit 2 (Day 0) to Week 26 in the maximal voluntary isometric contraction (MVIC) moment of the injured side as measured by isometric dynamometry to assess Gluteus Medius force strength.

Secondary Endpoints

Change From Day 0 to Week 26 in Muscle Volume.
Day 0 to Week 26
Change From Day 1 to Week 12 in Mean Fiber Diameter.
Day 1 to Week 12
Change From Day 0 to Week 26 in the Ratio of Injured to Contralateral Pelvic Shift .
Day 0 to Week 26
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
150M PLX-PADEXPERIMENTALSingle course, multiple IM injections
300M PLX-PADEXPERIMENTALSingle course, multiple IM injections
PlaceboPLACEBO_COMPARATORSingle course, multiple IM injections

Interventions

NameTypeDescription
150M PLX-PADBIOLOGICALSingle course, multiple IM injections
300M PLX-PADBIOLOGICALSingle course, multiple IM injections
PlaceboBIOLOGICALSingle course, multiple IM injections
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Eligibility Criteria

Age Range50 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Male or female subjects between 50 to 75 years of age 2. Scheduled THA 3. ASA Score ≤ 3 4. Signed written informed consent Exclusion Criteria: 1. Muscle diseases 2. Severe neurological diseases 3. Opioid long term medication 4. Pain chronification \> stadium II of Gerbersha...

Countries:Germany
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Frequently asked questions about 150M PLX-PAD

What is 150M PLX-PAD used for?

150M PLX-PAD is an investigational therapy being studied for use in total hip arthroplasty, specifically for the regeneration of injured gluteal musculature after the procedure. It is a monoclonal antibody developed by Pluri Inc. and is currently in Phase 1 clinical development.

What does 150M PLX-PAD target?

150M PLX-PAD is a monoclonal antibody, but its specific molecular target has not been disclosed. The therapy is being investigated for its potential to regenerate injured gluteal musculature following total hip arthroplasty, based on a completed Phase 1 clinical trial.

Who makes 150M PLX-PAD?

150M PLX-PAD is developed by Pluri Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol PLUR. The company is conducting clinical research on this therapy for the regeneration of injured gluteal musculature after total hip arthroplasty.

What phase is 150M PLX-PAD in?

150M PLX-PAD is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 clinical trial has been completed, and the therapy remains under investigation for its safety and efficacy.

What clinical trials is 150M PLX-PAD in?

150M PLX-PAD has one completed clinical trial registered as NCT01525667, titled 'Safety and Efficacy of IM Injections of PLX-PAD for the Regeneration of Injured Gluteal Musculature After Total Hip Arthroplasty.' This Phase 1 study enrolled 20 participants in Germany and was randomized, double-blind, and placebo-controlled.

Is 150M PLX-PAD the same as PLX-PAD?

150M PLX-PAD is a specific dose or formulation of the investigational therapy PLX-PAD, developed by Pluri Inc. The clinical trial NCT01525667 evaluated intramuscular injections of PLX-PAD for muscle regeneration after total hip arthroplasty, and 150M refers to the dose level studied.