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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2012-11-05 |
| Est. Completion | 2019-02-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗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.
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