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Adipose Cells for Degenerative Disc Disease

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: NCT02097862
Recruitment Status : Completed
First Posted : March 27, 2014
Last Update Posted : March 17, 2017
Sponsor:
Information provided by (Responsible Party):
Bioheart, Inc.

Tracking Information
First Submitted Date  ICMJE March 25, 2014
First Posted Date  ICMJE March 27, 2014
Last Update Posted Date March 17, 2017
Study Start Date  ICMJE March 2014
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2014)		 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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2014)		 Oswestry [ Time Frame: 12 months ]
Low back questionnaire designed to determine how low back pain has affected your daily life.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adipose Cells for Degenerative Disc Disease
Official Title  ICMJE 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
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 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Condition  ICMJE Degenerative Disc Disease
Intervention  ICMJE Procedure: Adipose Stem Cells
Injection of adipose derived stem cells intra-discally
Study Arms  ICMJE Not Provided
Publications * Comella K, Silbert R, Parlo M. Effects of the intradiscal implantation of stromal vascular fraction plus platelet rich plasma in patients with degenerative disc disease. J Transl Med. 2017 Jan 13;15(1):12. doi: 10.1186/s12967-016-1109-0. Erratum In: J Transl Med. 2017 May 22;15(1):108.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2017)		 15
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2014)		 100
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Degenerative disease of one, two, or three lumbar discs with predominant back pain after conservative treatment (physical and medical) for over 6 months.
  • Fibrous ring capable of holding the cell implantation, demonstrated by RMI image
  • Absence of spinal infection.
  • Haematological and biochemical analysis with no significant alterations that contraindicates intervention.
  • The patient is able to understand the nature of the study.
  • Informed written consent of the patient.

Exclusion Criteria:

  • Congenital or acquired diseases leading to spine deformations that may upset cell application.
  • Spinal segmental instability, spinal canal stenosis, isthmus pathology and other conditions that may compromise the study
  • Modic III changes on MRI images (31).
  • More than 50% loss of height
  • Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
  • Life expectancy < 6 months due to concomitant illnesses.
  • Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
  • Active infectious disease. Patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis will have an expert consultation as to patient eligibility based on the patient's infectious status
  • Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
  • Patients on chronic immunosuppressive transplant therapy
  • Systolic blood pressure (supine) ≤90 mmHg or greater than 180mmHg
  • Resting heart rate > 100 bpm;
  • Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
  • History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
  • Active clinical infection
  • Unwilling and/or not able to give written informed consent.
  • Recent smoking history or substance abuse (within six weeks)
  • Use of > 20 alcoholic drinks per week
  • Patients on Plavix or equivalent platelet inhibitors
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02097862
Other Study ID Numbers  ICMJE ADI-US-DDD-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bioheart, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bioheart, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bioheart, Inc.
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP