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Safety and Preliminary Efficacy Study of Mesenchymal Precursor Cells (MPCs) in Subjects With Lumbar Back Pain

NCT01290367 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-06-26

No results posted yet for this 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

Conditions

  • Degenerative Disc Disease

Interventions

BIOLOGICAL

Single Dose MPCs Injection

Injection of Low Dose MPCs with Hyaluronic Acid into the degenerated lumbar disc's nucleus pulposus.

PROCEDURE

Single injection of saline solution

Intradiscal control injection with saline solution

PROCEDURE

Single injection of hyaluronic acid

Intradiscal control injection with hyaluronic acid

BIOLOGICAL

Single Dose MPCs Injection

Injection of HighDose MPCs with Hyaluronic Acid into the degenerated lumbar disc's nucleus pulposus.

Sponsors & Collaborators

  • Mesoblast, Ltd.

    lead INDUSTRY

Principal Investigators

  • Roger Brown · Mesoblast, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-07-31
Completion
2015-07-31

Countries

  • United States
  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01290367 on ClinicalTrials.gov