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

NCT02529566 | Unknown

• 1 other identifier: HSC-2013
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lumbar Degenerative Disc Disease; Lower Back Pain; Chronic Lower Back Pain

Keywords

Lumbar Degenerative Disc Disease; Degenerative Spinal Conditions; Adjacent Segment Disease; Autologous Bone Marrow; Lower Back Pain; Chronic Lower Back Pain; Stem Cells; Lumbar disk; Mesenchymal Stem Cells; Stabilization; CLBP; Autograft; Allograft; Autograft versus Allograft; Facet Joint; Radicular Pain; Adipose; Disc Replacement; Facet Joint Replacement

Outcome Measures

Primary Outcomes (2)

• Numeric Pain Rating Scale (NPRS)

  Screening to 24 months

• Oswestry Disability Index (ODI)

  Screening to 24 months

Secondary Outcomes (2)

• SF-12 Health Survey

  Screening to 24 months

• EQ-5D Quality Adjusted Life Years

  Screening to 24 months

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients between the age of 18-85 years who presents problems of degenerative lumbar disk.

You may qualify if:

• 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.

You may not qualify if:

• Females who are pregnant or nursing, or plan on becoming pregnant during the 1st year after the procedure.

Sponsors & Collaborators

• The Foundation for Spinal Research, Education and Humanitarian Care, Inc.: lead

Study Sites (1)

Trinity Stem Cell Institution

Odessa, Florida, 33556, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Low Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Farhan N Siddiqi, MD

  Foundation For Spinal Research Education And Humanitarian Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: August 20, 2015
• Study Start: July 1, 2013
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: February 15, 2017

Record last verified: 2017-02

Locations

US (1)