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NCT01290367 · ClinicalTrials.gov registry record · Phase 2
Safety and Preliminary Efficacy Study of Mesenchymal Precursor Cells (MPCs) in Subjects With Lumbar Back Pain
A Phase 2 study, sponsored by Mesoblast.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT01290367 is a Phase 2 study that has completed, run by Mesoblast. The registered enrollment target is 100 participants.
The verdict
NCT01290367, a Phase 2 study, has completed, sponsored by Mesoblast.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
The purpose of this study is to compare two doses of immunoselected, culture-expanded, nucleated, allogeneic adult MPCs when combined with hyaluronic acid to two control intradiscal injections in subjects with chronic low back pain due to moderate Degenerative Disc Disease (DDD) at one lumbar level from L1 to S1. All investigational subjects in this study will undergo injection of either 6 million (M) or 18M cells in a hyaluronic acid carrier into the degenerated lumbar disc's nucleus pulposus. All control subjects will undergo an intradiscal control injection with either saline or hyaluronic acid only
Interventions
- BIOLOGICAL Single Dose MPCs Injection
- PROCEDURE Single injection of saline solution
- PROCEDURE Single injection of hyaluronic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2011-08 |
| Est. Completion | 2015-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01290367
The ClinicalTrials.gov registry entry for NCT01290367 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mesoblast, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Single Dose MPCs Injection is the first listed.
NCT01290367 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01290367 about?
NCT01290367 is a clinical study titled "Safety and Preliminary Efficacy Study of Mesenchymal Precursor Cells (MPCs) in Subjects With Lumbar Back Pain". The purpose of this study is to compare two doses of immunoselected, culture-expanded, nucleated, allogeneic adult MPCs when combined with hyaluronic acid to two control intradiscal injections in subjects with chronic low back pain due to moderate Degenerative Disc Disease (DDD) at one lumbar level ...
What is the current status of trial NCT01290367?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2011-08. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01290367?
The interventions under investigation include: Single Dose MPCs Injection (BIOLOGICAL), Single injection of saline solution (PROCEDURE), Single injection of hyaluronic acid (PROCEDURE).
Who is sponsoring clinical trial NCT01290367?
This trial is sponsored by Mesoblast, which has 25 total clinical trials registered on ClinicalTrials.gov.
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