Adipose Cells for Degenerative Disc Disease

Completed · Not applicable

Conditions studied: Degenerative Disc Disease

In brief

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.

Key facts

Study ID

NCT02097862

Run by

Bioheart, Inc.

People needed

15

Starts

2014-03-01

Expected to finish

2017-01-01

Last updated by the study team

2017-03-17

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• US Stem Cell Clinic — Sunrise, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.