Status:
COMPLETED
Adipose Stem Cells for Traumatic Spinal Cord Injury
Lead Sponsor:
Mohamad Bydon
Conditions:
Spinal Cord Injuries
Paralysis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine if mesenchymal stem cells (MSC) derived from the fat tissue can be safely administered into the cerebrospinal fluid (CSF) of patients with spinal cord injury....
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Male or female aged 18 years and older
- 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.
- 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.
- AIS grade A or B of SCI
- SCI must be traumatic, blunt/non-penetrating in nature and not degenerative
- SCI must be within two weeks and up to 1 year after the event
- 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
- 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
- Pregnant or nursing, or planning on becoming pregnant during the study period
- AIS grade of SCI other than A or B
- 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 the time 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 other antimetabolites) 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 at baseline
- 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.
- 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).
- 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.
- 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 months of 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 to undergo MRI procedures
- 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
- Patients with baseline depression, diagnosed by the Beck Depression Inventory Assessment
Key Trial Info
Start Date :
December 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03308565
Start Date
December 5 2017
End Date
October 11 2021
Last Update
August 30 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Rochester, Minnesota, United States, 55905