NeoFuse™ Trials

NeoFuse™ Clinical Study for Patients Diagnosed with Cervical (Neck) Degenerative Disc Disease at 2 or More Adjacent Levels

Clinical trial for patients with a diagnosis of cervical degenerative disc disease (DDD) at 2 or more adjacent cervical vertebral levels between C3-C4 to C7-T1 and who are eligible to undergo 2 or 3 level anterior cervical discectomy and fusion with anterior cervical plate fixation.

Introduction

Back and neck pain affect more than 80 percent of Americans some time in their lives and accounts for more sick leave and disability than any other medical condition. More than 500,000 spinal fusion procedures for chronic low back and neck pain are performed annually in the United States alone.

Mesoblast is currently evaluating the effectiveness and safety of adult stem cells (NeoFuse™) for cervical spinal fusion surgery in 24 patients randomized to receive either NeoFuse™ or standard therapy in a Phase 2 trial cleared by the United States Food and Drug Administration (FDA).

The cervical fusion study will compare the results of using NeoFuse™ adult stem cells against the standard therapy, cadaver bone graft, in two or three level cervical (neck) fusion procedures. Mesoblast's NeoFuse™ aims to eliminate the need for the use of cadaver bone graft, with its increased rate of non-union compared to single level cervical fusions.

The cervical fusion study is investigating whether a product containing proprietary adult stem cells, called NeoFuse™, can provide equivalent or better fusion outcomes compared to cadaver bone graft following conventional two or three level cervical fusion procedures. Patients in the NeoFuse™ study group will receive an implantation of NeoFuse™ adult stem cells mixed with a carrier graft material in a polymer cage between the bones that require fusion. The control group will receive a bone graft from a cadaver donor (allograft). Both groups will also use a cervical plate to provide additional stabilization.

About NeoFuse™

NeoFuse™ stem cells used in these clinical studies are a type of adult stem cell called mesenchymal precursor cells or MPCs that are derived from the bone marrow of healthy young adults. They are screened for communicable diseases, purified and grown into very large quantities in a sterile controlled laboratory environment.

Stem cell therapy is emerging as a new paradigm for treating and potentially curing human disease. It involves the use of living cells to replace and initiate the production of other cells that are missing or damaged due to disease or injury.

Study objectives

This is a prospective, multicenter, randomized, single-blinded, controlled study. The purpose of the study is to evaluate the safety and preliminary efficacy of immunoselected, culture-expanded, adult, allogeneic MPCs (NeoFuse) combined with a carrier material (a bone filler/calcium compound) in a commercially available cervical spacer (implant used to aid in cervical fusion) compared to an active control (a cadaver bone graft spacer placed between the boes of the neck) in subjects undergoing 2 or 3 level anterior cervical discectomy and fusion with anterior cervical plate fixation.

Study overview

The study will be conducted at up to 10 investigational clinics in the United States to enroll up to 24 patients. Eligible patients are those who have been diagnosed with degenerative disc disease (DDD) at 2 or more adjacent cervical vertebral levels between C3-C4 to C7-T1 and who are eligible for a two or three level cervical (neck) fusion procedure.

Participants who enroll in this study will be evaluated clinically and radiographically (with the aid of X-rays) within 3 days and 30 days after surgery, and at 3, 6, 12, and 24 months after surgery. The safety profile will be evaluated at the same time.

Study sponsor

Mesoblast, Limited.

Status

Actively recruiting

Who can participate in the NeoFuse™ Trial?

You must meet all of the eligibility criteria in order to participate. Some of the major inclusion and exclusion criteria are listed below:

• Male or females between 18 and 70 years of age, inclusive.
• Has the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
• Has the ability to understand and provide written authorization for the use and disclosure of personal health information (PHI).
• Has a documented symptomatic diagnosis of DDD at C3-C4 to C7-T1.
• Has symptomatic radiculopathy and/or myelopathy correlating to radiographic findings of duration of 6 weeks or greater that had failed to respond to non-operative management
• Is a candidate for anterior cervical discectomy and fusion in two or three adjacent cervical interbody levels between C3-C4 to C7-T1

Exclusion criteria

YOU MAY NOT be eligible to participate in this study based on the following:

• Female subjects who are pregnant or nursing, or women planning to become pregnant during the first year (12 months) following surgery.
• Have a current or prior history within the last 3 years of neoplasm (abnormal growth of tissue/cancer), excluding basal cell carcinoma, and/or any active neoplasm within the last 24 months, prior to screening.
• Have or are undergoing revision of a prior fusion surgery at any involved level.
• Require ACDF at only one cervical interbody level or more than 3 adjacent cervical interbody levels.
• Require ACDF without the use of an anterior cervical plating system.
• Have osteoporosis as defined by a DEXA T score of ≤ -3.0 or a history of fragility fractures or other significant bone disease contraindicating the use of spinal instrumentation.
• Have a positive screen for human immunodeficiency virus (HIV) antibodies.
• Have had treatment with any investigational therapy or device within 6 months of study surgery and/or plans to participate in any other allogeneic stem cell/progenitor cell therapy trial during the 2-year follow-up period.
• Have been a recipient of prior stem cell/progenitor cell therapy for spinal fusion surgery.

There are additional inclusion/exclusion criteria. Only a doctor participating in the NeoFuse™ Trial will be able to determine if you meet all of the inclusion and exclusion criteria, and are eligible to be a study participant.

Participating clinics

• Santa Monica, California
• Greenwood Village, Colorado
• Loveland, Colorado

Interested in participating?

To see if you or someone you know may qualify for participation in this clinical study, please take this short survey.