Stem cell bone graft shows promise for back pain relief
NCT ID NCT00948831
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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51 people
The number who actually took part.
- Start date
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Apr 2009
- Finished
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Oct 2012
- Lead sponsor
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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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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Central Texas Spine Institute, Northwest Hills Surgical Hospital
Austin, Texas, 78731, United States
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Cleveland Clinic
Cleveland, Ohio, 44195, United States
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Indiana Spine Group, St. Joseph's Hospital
Kokomo, Indiana, 46901, United States
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Ortho Montana
Billings, Montana, 59101, United States
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OrthoIndy, Indiana Orthopedic Hospital
Indianapolis, Indiana, 46278, United States
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Twin Cities Orthopaedics, University of Minnesota Medical Center
Edina, Minnesota, 55435, United States
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University of California at San Francisco
San Francisco, California, 94143, United States
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