Study of 3 Doses of NeoFuse Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion (PLF)

NCT00549913 | Completed Phase 1 DMC

• 1 other identifier: MSF0106
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a first-in-human, dose escalation clinical study to evaluate the feasibility, safety, and tolerability of 3 different doses of immunoselected, culture-expanded, nucleated, allogeneic MPCs (NeoFuse) when combined with MasterGraft Resorbable Ceramic Granules (Medtronic Sofamor Danek USA, Inc.) compared to autograft in patients requiring posterior lumbar interbody fusion with NuVasive's radiolucent PEEK OPTIMA cage (to be used with autologous bone graft material) and 1 or 2 level posterolateral lumbar fusion surgery with instrumentation. The instrumentation used for this study will be the Monarch® 5.50 mm Spine System (DePuy).

Conditions

Degenerative Disc Disease; Spondylolisthesis; Spinal Stenosis

Keywords

adjacent vertebral levels between L1 and S1

Outcome Measures

Primary Outcomes (1)

• To determine the safety of NeoFuse (allogeneic mesenchymal precursor cells [MPCs]) when combined with MasterGraft Resorbable Ceramic Granules as a carrier for posterolateral lumbar fusion with instrumentation.

  30 days

Secondary Outcomes (3)

• To evaluate the overall fusion success of the use of NeoFuse plus carrier compared to autograft in the same patient

  3 years

• To assess CT scan as a pilot measure of fusion for use in the pivotal study

  3 years

• To provide preliminary data to support dose selection

  3 years

Study Arms (6)

1

EXPERIMENTAL

10 subjects to receive lowest dose of NeoFuse (MPCs)

Biological: NeoFuse

2

ACTIVE COMPARATOR

4 subjects standard posterolateral spinal fusion with instrumentation

Procedure: posterolateral spinal fusion with instrumentation

3

EXPERIMENTAL

10 subjects to receive middle dose of NeoFuse

Biological: NeoFuse

4

ACTIVE COMPARATOR

3 subjects standard posterolateral spinal fusion with instrumentation

Procedure: posterolateral spinal fusion with instrumentation

5

EXPERIMENTAL

10 subjects to receive highest dose of NeoFuse

Biological: NeoFuse

6

ACTIVE COMPARATOR

3 subjects with standard posterolateral spinal fusion with instrumentation

Procedure: posterolateral spinal fusion with instrumentation

Interventions

NeoFuse BIOLOGICAL

immunoselected, culture-expanded, nucleated, allogeneic MPCs (NeoFuse) combined with MasterGraft Resorbable Ceramic Granules in subjects requiring posterior lumbar interbody fusion with NuVasive's radiolucent PEEK OPTIMA cage

Also known as: Spinal Fusion, Stem Cells

1; 3; 5

posterolateral spinal fusion with instrumentation PROCEDURE

autograft in subjects requiring posterior lumbar interbody fusion with NuVasive's radiolucent PEEK OPTIMA cage

Also known as: Spinal Fusion, Controls

2; 4; 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women ≥ 18 years of age.
• Have a documented symptomatic diagnosis of DDD at L1-S1 with or without stenosis and with or without up to and including Grade II degenerative spondylolisthesis.
• May also have coexistent spinal or foraminal stenosis as confirmed by MRI or CT evaluation.
• Must have clinical symptoms of neurogenic claudication.
• Must have failed 6 months of nonoperative management.
• Must be a candidate for lumbar interbody fusion in combination with posterolateral lumbar fusion with the use of autograft from the iliac crest requiring a 1 or 2-level fusion of adjacent vertebral levels between L1 and S1.
• Must have a stable screening electrocardiogram (ECG), as determined by the investigator that would not preclude surgery.

You may not qualify if:

• Is pregnant or breastfeeding.
• Has Grade III or greater spondylolisthesis.
• Has or is undergoing revision of a prior fusion at the involved levels.
• Has a history of hypersensitivity or anaphylactic reaction to murine or bovine products, dimethyl sulfoxide (DMSO), or titanium.
• Has MRI or CT that shows greater than 50% anterior translocation of cranial vertebral body or greater than 20 degree angular motion of the listhesis segment.
• Has a history of active malignancy in the last 5 years, other than basal cell carcinoma.
• Has osteoporosis as defined by a dual energy x-ray absorptiometry (DXA T) score of ≤ -3.5 or a history of fragility fractures or other significant bone disease contraindicating the use of spinal instrumentation.
• Note: subjects will be screened using the Simple Calculated Osteoporosis Risk Evaluation (SCORE) osteoporosis questionnaire.
• Has a history of Paget's disease of the spine, osteomalacia, or any other metabolic bone disease.
• Has a history of prior radiotherapy to the involved area.
• Has received systemic corticosteroids at a dose equivalent to prednisone \> 10 mg/day within 14 days prior to study procedure.
• Has received systemic nonsteroidal anti-inflammatory drugs (NSAIDS) within 48 hours prior to study procedure, and unwilling to refrain from NSAIDS for the first 6 months following the procedure.
• Has a positive screen for human immunodeficiency virus (HIV) antibodies.
• Has had treatment with any investigational therapy administered within 6 months before implantation surgery. .
• Is the prior recipient of allogeneic stem cell/progenitor cell therapy.

Sponsors & Collaborators

• Mesoblast, Ltd.: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Links

• The Sponsor's web site

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spondylolisthesis; Spinal Stenosis

Interventions

Spinal Fusion

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Intervention Hierarchy (Ancestors)

Arthrodesis; Orthopedic Procedures; Surgical Procedures, Operative

Study Officials

• Donna Skerrett, MD

  Mesoblast, Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2007
• First Posted: October 26, 2007
• Study Start: October 1, 2007
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2013
• Last Updated: June 29, 2020

Record last verified: 2020-06

Locations

US (1)