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PLX-PAD for Hip Fracture

Q: Has PLX-PAD completed the process of FDA approval?

PLX-<a href="https://www.withpower.com/clinical-trials/pad">PAD</a> has received a Phase 3 safety rating from our team at Power. This is due to a few reasons; there is data supporting efficacy and multiple rounds of data supporting safety.

Q: Will this clinical trial be used to set a precedent?

PLX-<a href="https://www.withpower.com/clinical-trials/pad">PAD</a> has a history dating back to 2018 when the first clinical trial began. That first study was conducted by Pluristem Ltd and involved 240 people. After a successful first trial, PLX-PAD received Phase 3 approval in 2018. Now, there are 3 active trials being conducted in 6 cities and 6 countries.

Q: Are there any other available PLX-PAD studies that I could reference?

There are three active clinical trials studying PLX-<a href="https://www.withpower.com/clinical-trials/pad">PAD</a>. One of those trials is in Phase 3. The many studies for PLX-PAD are based in Kfar-Saba, <a href="https://www.withpower.com/clinical-trials/colorado">Colorado</a>, but there are 21 locations running trials for this treatment.

Phase 3

Waitlist Available

Research Sponsored by Pluristem Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52.

Awards & highlights

Study Summary

This trial will test a new drug to treat muscle injury after surgery for hip or knee replacement. The goal is to see if it is safe and effective.

Eligible Conditions

Hip Fracture

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52.

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Short Physical Performance Battery (SPPB) score

Secondary outcome measures

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

Hip abduction strength of the injured leg

SPPB score

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PLX-PADExperimental Treatment1 Intervention

• 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.

Group II: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PLX-PAD

2009

Completed Phase 3

~260

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Pluristem Ltd.Lead Sponsor

10 Previous Clinical Trials

577 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study allow for patients who are adults?

"As long as you are between 0 and 90 years old, you meet the age requirements for this clinical trial."

Answered by AI

Are there specific eligibility requirements for subjects of this research?

"This clinical trial is for people who have fractures and are below 90 years of age. Around 240 people are needed for the study."

Answered by AI

Has PLX-PAD completed the process of FDA approval?

"PLX-PAD has received a Phase 3 safety rating from our team at Power. This is due to a few reasons; there is data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

Will this clinical trial be used to set a precedent?

"PLX-PAD has a history dating back to 2018 when the first clinical trial began. That first study was conducted by Pluristem Ltd and involved 240 people. After a successful first trial, PLX-PAD received Phase 3 approval in 2018. Now, there are 3 active trials being conducted in 6 cities and 6 countries."

Answered by AI

How many patients are being allowed to enroll in this research project?

"Unfortunately, this particular study is not currently seeking patients. However, it is worth noting that this study was first posted on 7/26/2018 and was most recently edited on 11/30/2021. Additionally, there are 385 other studies actively recruiting participants with fracture and 3 trials for PLX-PAD that are also recruiting patients."

Answered by AI

Are there any other available PLX-PAD studies that I could reference?

"There are three active clinical trials studying PLX-PAD. One of those trials is in Phase 3. The many studies for PLX-PAD are based in Kfar-Saba, Colorado, but there are 21 locations running trials for this treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "Treatment of Muscle Injury Following Arthroplasty for Hip Fracture (HF)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03451916.