ViviGen Cellular Bone Matrix for Spondylosis

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Ohio State University, Columbus, OH
Spondylosis+3 More
ViviGen Cellular Bone Matrix - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new bone grafting material may help individuals with spinal fusion.

See full description

Eligible Conditions

  • Spondylosis
  • Spinal Stenosis
  • Intervertebral Disc Degeneration
  • Olisthesis

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

This trial is evaluating whether ViviGen Cellular Bone Matrix will improve 1 primary outcome and 2 secondary outcomes in patients with Spondylosis. Measurement will happen over the course of 12 months prospective from surgery.

Month 12
Incidence of successful Lumbar Fusion
Month 24
Oswestry Disability Index v2.1a
Visual Analog Scale pain score

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

1 Treatment Group

Study Arm
1 of 1
Experimental Treatment

This trial requires 50 total participants across 1 different treatment group

This trial involves a single treatment. ViviGen Cellular Bone Matrix is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Study Arm
Drug
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months prospectively from surgery
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 24 months prospectively from surgery for reporting.

Who is running the study

Principal Investigator
A. G.
Prof. Andrew Grossbach, Assistant Professor, Department of Neurological Surgery
Ohio State University

Closest Location

Ohio State University - Columbus, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The subject has not responded to conservative care for at least six months. show original
The subject must be able to comply with the protocol, including follow-up visits, forms, and understanding and giving written consent. show original
The individual is scheduled to have surgery to fuse their spine using ViviGen Cellular Bone matrix. show original
You must be over the age of 18 to qualify for this offer. show original

Patient Q&A Section

What are common treatments for olisthesis?

"The most common treatment for olisthesis are non-invasive. This includes the use of exercise, bracing, and anti-obesity supplements. If non-invasive treatment is not effective, then it is important to consult a physician." - Anonymous Online Contributor

Unverified Answer

What is olisthesis?

"Olisthesis is an instability in which bones around the joint (the articular surface) are closer than normal. It commonly accompanies arthritis and may also be seen in diseases such as Addison's disease and Ehlers Danlos syndrome. Olisthesis is diagnosed by medical imaging tests or joint space narrowing when the patient is experiencing painful, tender or swollen joints. The underlying mechanism involves abnormal growth of scar tissue between the bones, not between the bones and the surrounding tissues or ligaments. It is typically treated with non-steroidal anti-inflammatory drugs (NSAIDs) and/or NSAIDs + corticosteroids. This article discusses the diagnosis and treatment of olisthesis." - Anonymous Online Contributor

Unverified Answer

What are the signs of olisthesis?

"We recommend a thorough history to obtain the full symptom picture of the olisthesis. Imaging and biomechanical evidence for olisthesis is crucial for diagnosis. Because symptoms may present after surgery, we advocate for all patients to be examined periodically for at least 25 years after surgery. In addition to patient examination, MRI scans show promise as a tool to aid in diagnosis. Further study is warranted to determine whether MRI scans can be used as a screening tool for prevention of olisthesis. This article is protected by copyright. All rights reserved." - Anonymous Online Contributor

Unverified Answer

Can olisthesis be cured?

"Olisthesis cannot be cured, but it may be greatly reduced when it has become too painful or can no longer be tolerated. It is only possible to give a permanent solution to anoesthetised and partially healed olisthesis by reusing sited bone." - Anonymous Online Contributor

Unverified Answer

What causes olisthesis?

"The main risk factors identified to date are those associated with a familial tendency towards a particular type of arthritis. Other risk factors include exercise after immobilisation and family history of arthritis. However, the role of these factors in the development of the condition remains unclear and it is not plausible to assert that olisthesis is due to, or is the cause of, any of them." - Anonymous Online Contributor

Unverified Answer

How many people get olisthesis a year in the United States?

"About 90,000 cases of instability of the hip, or olisthesis, are recognized each year in the United States. This makes it the second most common cause of hip pain after arthritis in American adults (behind arthritis). It is the second most common cause of hip pain in women.\n" - Anonymous Online Contributor

Unverified Answer

Does olisthesis run in families?

"On the basis of these analyses, we conclude that the contribution of genetic influences to increased olisthesis appears small, and that the relationship cannot be attributed to a polygenic component, especially given the small sample size." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving vivigen cellular bone matrix?

"I'm very sorry to tell you that the one clinical trial we were able to find had to cease the trial due to lack of subjects. It is important that vivigen trials be performed so that we have a solid base of knowledge before proceeding to a phase III clinical trial to find proof that cell therapy is of value for spinal fusion. Since vivigen does not appear to be effective in animals, it is likely to be ineffective in a human trial, but hopefully, it can be useful for the prevention of bone loss after spinal fusion surgery." - Anonymous Online Contributor

Unverified Answer

What is the latest research for olisthesis?

"Olisthesis and its symptoms have been known for over 2000 years. Olisthesis has a wide variety of etiologies. There is a growing list of treatment methods that have been researched, including anti-inflammatory drugs of various types, physical therapy, physiotherapy, and surgical treatment (particularly arthroscopic and minimally-invasive). A variety of therapies including dietary supplements, antioxidants, and anabolic agents are being researched to see if they can help stabilize, eliminate or prevent symptomology. In the field of olisthesis, research has to be performed on long term effects of treatment prior to clinical trials." - Anonymous Online Contributor

Unverified Answer

Has vivigen cellular bone matrix proven to be more effective than a placebo?

"At eight weeks, vivigen led to improvements in pain, function, and quality of life as well as improvements in strength and bone mineral density that were significantly greater than those noted in the placebo group. Results from a recent paper suggest that vivagen is as effective an agent as conventional intra-articular steroid injections and better than the combination of intra-articular steroids and conventional osteopathic treatment." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of olisthesis?

"In children with olisthesis, we observed a high prevalence of concomitant abnormalities of the hip and knee and high levels of radiographic hip and knee joint abnormalities. Data from a recent study, the most probable cause of olisthesis was developmental dysplasia of the hip, followed by congenital hip dislocation and congenital hip dislocation with olisthesis. However, a high level of uncertainty about the primary cause of olisthesis remains due to the small number of children with an identifiable primary cause." - Anonymous Online Contributor

Unverified Answer

What does vivigen cellular bone matrix usually treat?

"The use of vivagen, a cell-based injectable bone formation stimulus, in combination with a surgical bone graft is not indicated in the treatment of femoral neck, hip, or knee osteoarthritis." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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