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Stem cell bone graft shows promise for back pain relief

NCT ID NCT00948831

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a special bone graft called Osteocel Plus, which contains stem cells, helps the spine bones fuse together after surgery. It included 51 adults with degenerative disc disease who had not improved with other treatments. The goal was to see if this graft works as well as using the patient's own bone for fusion.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

51 people

The number who actually took part.

Start date

Apr 2009

Finished

Oct 2012

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Existing clinic patients

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Persistent back and/or leg pain unresponsive to conservative treatment for at least six (6) months, unless clinically indicated earlier 2. Indicated for interbody fusion of one or two contiguous lumbar segments (L1 to S1) 3. Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies 4. 18-70 years of age at the date of written informed consent 5. Able to undergo surgery based on physical exam, medical history and surgeon judgment 6. Expected to survive at least 2 years beyond surgery 7. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol 8. Signed and dated Informed Consent Form Exclusion Criteria: 1. Patient has a mental or physical condition that would limit the ability to comply with study requirements 2. Lumbar spine abnormality requiring treatment at more than two levels 3. Systemic or local infection; active or latent 4. Previous failed fusion at the operative level 5. Diseases that significantly inhibit bone healing (osteoporosis, metabolic bone disease, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease) 6. Undergoing chemotherapy or radiation treatment, or chronic use of steroids (defined as more than 6 weeks of steroid use within 12 months of surgery, other than episodic use or inhaled corticosteroids) 7. Pregnant, or plans to become pregnant during the study 8. Subject is a prisoner 9. Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contended) 10. A significant general illness (e.g., HIV, active metastatic cancer of any type) is present; subject is immunocompromised or is being treated with immunosuppressive agents 11. Participating in another clinical study that would confound study data

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Central Texas Spine Institute, Northwest Hills Surgical Hospital

    Austin, Texas, 78731, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Indiana Spine Group, St. Joseph's Hospital

    Kokomo, Indiana, 46901, United States

  • Ortho Montana

    Billings, Montana, 59101, United States

  • OrthoIndy, Indiana Orthopedic Hospital

    Indianapolis, Indiana, 46278, United States

  • Twin Cities Orthopaedics, University of Minnesota Medical Center

    Edina, Minnesota, 55435, United States

  • University of California at San Francisco

    San Francisco, California, 94143, United States

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