Adipose Cells for Degenerative Disc Disease

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02097862
Study type	Interventional
Source	Bioheart, Inc.
Contact
Status	Completed
Phase	N/A
Start date	March 2014
Completion date	January 2017

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