Adipose Cells for Degenerative Disc Disease

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.

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