Adipose Stem Cells for Traumatic Spinal Cord Injury

The proposed study is an open label, prospective Phase I safety and feasibility study of the
intrathecal injection of autologous culture-expanded AD-MSCs in patients with severe
traumatic spinal cord injury (SCI). All subjects will receive the same dosage of stem cells
via intrathecal injection. Enrolled subjects will first undergo a minor surgical procedure in
which a sample of the patient's adipose tissue will be harvested from a small incision in the
patient's abdomen or thigh. The subject's adipose tissue will then be used to derive and
culture-expand AD-MSCs for 4-6 weeks. Autologous AD-MSCs will be transplanted through
intrathecal injection at the level of L4-5 under fluoroscopic guidance at a single dose of
100 million cells. Patients will be evaluated at set intervals following the injection: day
2, day 3, week 1, week 2, week 4, week 24, weeks 48, week 72 and week 96.

Inclusion Criteria:

1. Male or female aged 18 years and older

1. Females of childbearing potential must have a negative pregnancy test prior to
receiving the study drug and will agree to use adequate contraception
(hormonal/barrier method or abstinence) from the time of screening to a period of
1 year following completion of the drug treatment cycle. Females of childbearing
potential are defined as premenopausal and not surgically sterilized, or
post-menopausal for fewer than 2 years. If the urine pregnancy test is positive,
the study drug will not be administered and the result will be confirmed by a
serum pregnancy test. Serum pregnancy tests will be performed at a central
clinical laboratory, whereas urine pregnancy tests will be performed by qualified
personnel using kit.

2. Females becoming pregnant during the study will continue to be monitored for the
duration of the study or completion of the pregnancy, whichever is longer.
Monitoring will include perinatal and neonatal outcome. Any SAEs associated with
pregnancy will be recorded.

2. AIS grade A or B of SCI

3. SCI must be traumatic, blunt/non-penetrating in nature and not degenerative

4. SCI must be within two weeks and up to 1 year after the event

5. Full understanding of the requirements of the study and willingness to comply with the
treatment plan, including fat harvesting, laboratory tests, diagnostic imaging,
complete physical and neurologic examination and follow-up visits and assessments

6. Once the nature of the study is fully explained and prior to any study-related
procedure is initiated the subject is willing to provide written, informed consent and
complete HIPAA documentation

Exclusion Criteria:

1. Pregnant or nursing, or planning on becoming pregnant during the study period

2. AIS grade of SCI other than A or B

3. History of intra-spinal infection

4. History of superficial infection in the index spinal level within 6 months of study

5. Evidence of current superficial infection affecting the index spinal level at the time
of enrollment

6. On chronic, immunosuppressive transplant therapy or having a chronic,
immunosuppressive state, including use of systemic steroids/corticosteroids

7. Taking anti-rheumatic disease medication (including methotrexate or other
antimetabolites) within 3 months prior to study enrollment

8. Ongoing infectious disease, including but not limited to tuberculosis, HIV, hepatitis,
and syphilis

9. Fever, defined as temperature above 100.4 F/38.0 Celsius, or mental confusion at
baseline

10. Significant improvement between the time of adipose tissue harvest and the time of
injection, defined as improvement from AIS grade A or B to AIS grade C or greater.

11. Clinically significant cardiovascular (e.g. history of myocardial infarction,
congestive heart failure or uncontrolled hypertension > 90 mmHg diastolic and/or 180
mmHg systolic), neurological (e.g. stroke, TIA) renal, hepatic or endocrine disease
(e.g. diabetes, osteoporosis).

12. History of malignancy including melanoma with the exception of localized skin cancers
(with no evidence of metastasis, significant invasion, or re-occurrence within three
years of baseline). Any other malignancy will not be allowed.

13. History of blood dyscrasia, including but not limited to anemia, thrombocytopenia, and
monoclonal gammopathy

14. Participation in a study of an experimental drug or medical device within 3 months of
study enrollment

15. Known allergy to local anesthetics of other components of the study drug

16. Any contraindication to MRI scan according to MRI guidelines, or unwillingness to
undergo MRI procedures

17. History of or current evidence of alcohol or drug abuse or dependence, recreational
use of illicit drug or prescription medications, or use of medical marijuana within 30
days of study entry

18. Patients with baseline depression, diagnosed by the Beck Depression Inventory
Assessment