ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02529566
Recruitment Status : Enrolling by invitation
First Posted : August 20, 2015
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
The Foundation for Spinal Research, Education and Humanitarian Care, Inc.

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.

Condition or disease
Lumbar Degenerative Disc Disease Lower Back Pain Chronic Lower Back Pain

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Human Autograft Mesenchymal Stem Cell Mediated Stabilization of The Degenerative Lumbar Spine
Study Start Date : July 2013
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Numeric Pain Rating Scale (NPRS) [ Time Frame: Screening to 24 months ]
  2. Oswestry Disability Index (ODI) [ Time Frame: Screening to 24 months ]

Secondary Outcome Measures :
  1. SF-12 Health Survey [ Time Frame: Screening to 24 months ]
  2. EQ-5D Quality Adjusted Life Years [ Time Frame: Screening to 24 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients between the age of 18-85 years who presents problems of degenerative lumbar disk.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02529566


Locations
United States, Florida
Trinity Stem Cell Institution
Odessa, Florida, United States, 33556
Sponsors and Collaborators
The Foundation for Spinal Research, Education and Humanitarian Care, Inc.
Investigators
Principal Investigator: Farhan N Siddiqi, MD Foundation For Spinal Research Education And Humanitarian Care

Responsible Party: The Foundation for Spinal Research, Education and Humanitarian Care, Inc.
ClinicalTrials.gov Identifier: NCT02529566     History of Changes
Other Study ID Numbers: HSC-2013
First Posted: August 20, 2015    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017

Keywords provided by The Foundation for Spinal Research, Education and Humanitarian Care, Inc.:
Lower Back Pain
Chronic Lower Back Pain
Stem Cells
Mesenchymal Stem Cells
Radicular Pain
Lumbar Degenerative Disc Disease
Degenerative Spinal Conditions
Adjacent Segment Disease
Autologous Bone Marrow
Lumbar disk
Stabilization
CLBP
Autograft
Allograft
Autograft versus Allograft
Facet Joint
Adipose
Disc Replacement
Facet Joint Replacement

Additional relevant MeSH terms:
Back Pain
Intervertebral Disc Degeneration
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases