Clinical Trial: Adipose Cells for Degenerative Disc Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open Label, Non-Randomized, Multi-Center Study To Assess The Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intra-Discally in Patients With Degenerat

Brief Summary: The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed degenerative disc disease.

Detailed Summary:

This will be an open-label, non-randomized, multi-center study of ASC implantation performed intra-discally. ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells.

The adipose tissue specimen will be collected from the patient's abdomen using a liposuction cannula. In addition, a sample of peripheral blood will be collected for isolation of platelet rich plasma. The adipose tissue is processed for separation of the adipose tissue-derived stem cells, which are then resuspended in platelet rich plasma and transferred for intra-discal administration. The number of cells injected will vary depending on the amount of tissue processed and the number of cells obtained from the process. Following the injections follow-up data will be collected 3, 6 and 12 months after treatment.

Total study time frame is anticipated to be approximately 6 months. This study will enroll approximately 100 patients.


Sponsor: Bioheart, Inc.

Current Primary Outcome: Visual Analog Scale [ Time Frame: 12 months ]

This is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot be directly measured.


Original Primary Outcome: Same as current

Current Secondary Outcome: Oswestry [ Time Frame: 12 months ]

Low back questionnaire designed to determine how low back pain has affected your daily life.


Original Secondary Outcome: Same as current

Information By: Bioheart, Inc.

Dates:
Date Received: March 25, 2014
Date Started: March 2014
Date Completion:
Last Updated: March 15, 2017
Last Verified: March 2017