Could your own fat cells fight ALS? new trial tests safety and effectiveness
NCT ID NCT03268603
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment for ALS (Lou Gehrig's disease) using stem cells taken from the patient's own belly fat. The cells are injected into the fluid around the spine every 3 months for a year. The goal is to see if this treatment is safe and can slow down the disease. About 75 adults with ALS are taking part.
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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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75 people
The number who actually took part.
- Started
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Oct 2017
- Expected to finish
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Dec 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: * All patients will have ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by the World Federation of Neurology criteria for the diagnosis of ALS. * Examination and neurophysiological testing confirm a pure motor syndrome compatible with the diagnosis of ALS. All other possible causes of weakness have been excluded by extensive investigations. * Age greater than 18 years, if female, must be post-menopausal, had a hysterectomy, or agree to two forms of birth control. * Permanent resident or citizen of the United States. * Geographic accessibility to the study site and willingness and ability to comply with follow-up. * History of a chronic onset of a progressive motor weakness of less than two years duration. * Subjects must be taking a stable dose of riluzole for at least 30 days prior to enrolment or not be on riluzole, and not have been on it for at least 30 days prior to enrolment (riluzole-naïve subjects are permitted in the study). * Subjects must be taking a stable dose of oral Radicava® (edaravone) for at least 30 days prior to enrolment or not be on oral Radicava® (edaravone), and not have been on it for at least 30 days prior to enrolment (edaravone-naïve subjects are permitted in the study). * Able to comply with protocol requirements, including MRI testing. * Can provide written informed consent. Exclusion Criteria: * Use of Radicava® (edaravone) within 30 days of screening or intent to use Radicava® at any time during the course of the study including the follow up period. * Any clinically significant medical condition (e.g., within six months of baseline, had myocardial infarction, angina pectoris, and/or congestive heart failure) that, in the opinion of the investigator, would compromise the safety of patient. * Pulmonary Slow Vital Capacity (SVC) less than 65% of predicted for age, gender, and body type. * Autoimmunity, including Crohn's disease or rheumatoid arthritis * Current use of immunosuppressant medication or use of such medication within 4 weeks of Screening visit (Visit 1). * Malignancy 5 years prior to enrollment, including melanoma,with the exception of localized skin cancers (with no evidence of metastasis, significant invasion, or re-occurrence within three years of baseline). * Active systemic or local infection near the lumbar puncture site. * Inability to lie flat for the duration of intrathecal cell transplantation, or inability to tolerate study procedures for any other reason. * Other active systemic disease as defined by laboratory abnormalities delineated in Appendix IV. * Use of herbal medications, nutritional supplements or other unapproved drugs or investigational medicinal products being used or studied for the treatment of ALS. * Unwilling to forgo initiating the use of any new supplements during participation in the study. * Enrolled in an investigational drug trial within 30 days of baseline visit * Prior stem cell therapy for a neurological disease * Kokmen Short Test of Mental Status score \<32 * Presence of a tracheostomy * Ventilator dependent * Pregnancy * Men or women of childbearing potential who are unwilling to employ adequate contraception * Chronic low back pain requiring invasive procedures (i.e. epidural injections or lumbar spine surgery)
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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
Scottsdale, Arizona, 85259, United States
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Mayo Clinic
Jacksonville, Florida, 32224, United States
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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Other studies related to the condition(s) this trial covers.
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