Adipose Cells for Degenerative Disc Disease
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|ClinicalTrials.gov Identifier: NCT02097862|
Recruitment Status : Completed
First Posted : March 27, 2014
Last Update Posted : March 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Degenerative Disc Disease||Procedure: Adipose Stem Cells||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|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 Degenerative Disc Disease|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
- Procedure: Adipose Stem Cells
Injection of adipose derived stem cells intra-discally
- 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.
- Oswestry [ Time Frame: 12 months ]Low back questionnaire designed to determine how low back pain has affected your daily life.
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): NCT02097862
|United States, Florida|
|US Stem Cell Clinic|
|Sunrise, Florida, United States|