Could your own fat help you walk again? new stem cell trial for paralysis
NCT ID NCT04520373
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests if stem cells taken from a patient's own belly fat and injected into the spine can safely help restore movement and feeling after a spinal cord injury. About 40 adults with paralysis will receive the treatment. The goal is to see if this approach can improve function, but it is not expected to be a complete cure.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2020
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 at the time of injury with or without subsequent improvement within 1 year of injury that has progressed to a higher AIS grade with a plateau in functional 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 with the 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 by physical and occupational therapists. * 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: * 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 any indications * 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 * Diagnosis of schizophrenia or bipolar disorder * Patients with baseline depression, diagnosed by the Beck Depression Inventory Assessment * Currently taking riluzole for treatment of amyotrophic lateral sclerosis (ALS)
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Serotonin precursor probed for spinal cord injury effects
- Breathing brief Low-Oxygen bursts may boost sleep apnea treatment
- Pure oxygen tested as a switch for dormant nerves after spinal cord injury
- Spinal stimulation tested to help kids with spinal cord injuries sit taller
- Zapping the spine: a new hope for kids with paralysis?
- Can painless spinal zaps teach injured kids to walk again?