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Cell Therapy

ViviGen Cellular Bone Matrix for Spondylolisthesis

N/A
Waitlist Available
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has been unresponsive to conservative care for a minimum of 6 months.
Subject is scheduled to undergo a single or multilevel posterolateral spinal fusion surgery using ViviGen Cellular Bone matrix
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months prospective from surgery
Awards & highlights

Study Summary

This trial is testing a new way to fuse the spine in one or multiple levels. All subjects will be followed for 24 months.

Eligible Conditions
  • Spondylolisthesis
  • Degenerative Disc Disease
  • Spondylosis
  • Spinal Stenosis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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The subject has not responded to conservative care for at least six months.
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The individual is scheduled to have surgery to fuse their spine using ViviGen Cellular Bone matrix.
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You must be over the age of 18 to qualify for this offer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months prospective from surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months prospective from surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The Number of Surgical Levels With Successful Lumbar Fusion
Secondary outcome measures
Number of Participants With or Without Changes in Visual Analog Scale Pain Scores
Oswestry Disability Index (ODI) v2.1a

Trial Design

1Treatment groups
Experimental Treatment
Group I: Study ArmExperimental Treatment1 Intervention
Participants will be entered into the single armed study in which one side of the fusion will be coated with milled local autograft bone and the opposite fusion side will be supplemented with an equal volume of Depuy Synthes ViviGen.

Find a Location

Who is running the clinical trial?

DePuy SynthesIndustry Sponsor
30 Previous Clinical Trials
4,903 Total Patients Enrolled
3 Trials studying Spondylolisthesis
296 Patients Enrolled for Spondylolisthesis
Ohio State UniversityLead Sponsor
821 Previous Clinical Trials
501,114 Total Patients Enrolled
4 Trials studying Spondylolisthesis
310 Patients Enrolled for Spondylolisthesis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA approved ViviGen Cellular Bone Matrix for clinical use?

"ViviGen Cellular Bone Matrix has achieved a score of 3 on our team's risk scale since it is in its fourth phase of testing, which implies full approval."

Answered by AI

Is recruitment currently underway for this clinical trial?

"Affirmative. The clinicaltrial.gov page demonstrates that the trial is actively enrolling participants, having first been posted on February 12th 2019 and most recently updated on October 25 2021. This study looks to recruit 50 patients at a single site."

Answered by AI

How many individuals are being recruited into this research project?

"Affirmative. According to clinicaltrials.gov, this investigation is at present recruiting subjects. It was initially posted on February 12th 2019 and amended on October 25th 2021; it aims to enlist 50 participants from one single medical site."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
How old are they?
18 - 65
What site did they apply to?
Ohio State University
What portion of applicants met pre-screening criteria?
Met criteria
~3 spots leftby Mar 2025