Autologous Adipose Derived Mesenchymal Stem Cells for Spinal Cord Injury Patients

Inclusion Criteria:

• Male or female aged 18 years and older

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

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

• AIS grade A or B of SCI at the time of injury with or without subsequent improvementwithin 1 year of injury that has progressed to a higher AIS grade with a plateau infunctional improvement

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

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

• Full understanding of the requirements of home exercise program prescribed byphysical and occupational therapists.

• Once the nature of the study is fully explained and prior to any study-relatedprocedure is initiated the subject is willing to provide written, informed consentand complete HIPAA documentation

Exclusion Criteria:

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

• AIS grade of SCI other than A or B at the time of injury

• Non-traumatic SCI

• History of receiving mesenchymal stem cell, gene or exosome therapy for anyindications

• History of intra-spinal infection

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

• Evidence of current superficial infection affecting the index spinal level at thetime of enrollment

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

• Taking anti-rheumatic disease medication (including methotrexate or otherantimetabolites) within 3 months prior to study enrollment

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

• Fever, defined as temperature above 100.4 F/38.0 Celsius, or mental confusion atbaseline

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

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

• History of malignancy including melanoma with the exception of localized skincancers (with no evidence of metastasis, significant invasion, or re-occurrencewithin three years of baseline). Any other malignancy will not be allowed.

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

• Participation in a study of an experimental drug or medical device within 3 monthsof study enrollment

• Known allergy to local anesthetics of other components of the study drug

• Any contraindication to MRI scan according to MRI guidelines, or unwillingness toundergo MRI procedures

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

• Diagnosis of schizophrenia or bipolar disorder

• Patients with baseline depression, diagnosed by the Beck Depression InventoryAssessment

• Currently taking riluzole for treatment of amyotrophic lateral sclerosis (ALS)