UnknownNot Applicable

Human Autograft Mesenchymal Stem Cell Mediated Stabilization of The Degenerative Lumbar Spine

United States100 participantsStarted 2013-07

Plain-language summary

Investigate the potential of tissue grafting that includes human mesenchymal stem cells in the repair and potential stabilization of the degenerative Lumbar disk and facet joint denovo and at the time of surgical reconstruction. Our hypothesis proposes that stabilization will help restore normal structure and function in the degenerative lumbar spine may decrease chronic low back pain associated with the biomechanical demise of the degenerative disk or facet and may improve the natural history of adjacent segment disease found after spinal surgery.

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female subject, at least 18 years of age, who is unresponsive to conservative therapy and needs surgical reconstruction of the degenerative lumbar spine. Exclusion Criteria: * Females who are pregnant or nursing, or plan on becoming pregnant during the 1st year after the procedure.

What they're measuring

Numeric Pain Rating Scale (NPRS)

Timeframe: Screening to 24 months

Oswestry Disability Index (ODI)

Timeframe: Screening to 24 months

Trial details

NCT IDNCT02529566

SponsorThe Foundation for Spinal Research, Education and Humanitarian Care, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-07

View on ClinicalTrials.gov More Lumbar Degenerative Disc Disease trials