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NCT01679990 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy of Allogeneic Cells for the Treatment of Intermittent Claudication(IC)

A Phase 2 study, sponsored by Pluristem.

Completed
Registry status
Phase 2
Development phase
180
Enrollment target

NCT01679990 is a Phase 2 study that has completed, run by Pluristem. The registered enrollment target is 180 participants.

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The verdict

NCT01679990, a Phase 2 study, has completed, sponsored by Pluristem.

COMPLETED
Registry status
Phase 2
Development phase
180 participants
Enrollment target

Study Summary

The objective of the study is to establish the safety profile of Intramuscular PLX-PAD injections and to evaluate the clinical efficacy of it in IC subjects comprising of 4 treatment groups: 1. Double treatment of PLX-PAD low dose 2. Double treatment of PLX-PAD high dose 3. Double treatment of Placebo 4. Single treatment of PLX-PAD high dose and additional treatment of Placebo. Subjects will receive the assigned treatment twice to the affected leg, within 12-weeks interval between each treatment. The study will be comprised of 5 stages: Screening period of up to 4 weeks,first treatment of PLX-PAD or placebo followed by additional injection after 12 weeks and with follow-up of 12 months post second injection

Interventions

  • BIOLOGICAL PLX-PAD Low dose
  • BIOLOGICAL PLX-PAD high doses
  • BIOLOGICAL Double Placebo
  • BIOLOGICAL high dose +Placebo

Trial Details

FieldValue
Enrollment Target 180 participants
Start Date 2012-11-05
Est. Completion 2019-02-09
Phase Phase 2

Sponsor

Pluristem

6 total trials

What the Registry Record Tells You About NCT01679990

The ClinicalTrials.gov registry entry for NCT01679990 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pluristem, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which PLX-PAD Low dose is the first listed.

NCT01679990 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01679990 about?

NCT01679990 is a clinical study titled "Safety and Efficacy of Allogeneic Cells for the Treatment of Intermittent Claudication(IC)". The objective of the study is to establish the safety profile of Intramuscular PLX-PAD injections and to evaluate the clinical efficacy of it in IC subjects comprising of 4 treatment groups: 1. Double treatment of PLX-PAD low dose 2. Double treatment of PLX-PAD high dose 3. Double treatment of Pla...

What is the current status of trial NCT01679990?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2012-11-05. Estimated completion is 2019-02-09.

What interventions are being tested in trial NCT01679990?

The interventions under investigation include: PLX-PAD Low dose (BIOLOGICAL), PLX-PAD high doses (BIOLOGICAL), Double Placebo (BIOLOGICAL), high dose +Placebo (BIOLOGICAL).

Who is sponsoring clinical trial NCT01679990?

This trial is sponsored by Pluristem, which has 6 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.