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Mesenchymal Stem Cells
Stem Cell Therapy for ALS
Phase 2
Waitlist Available
Led By Anthony J Windebank, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2 years
Awards & highlights
Study Summary
This trial will test the safety and efficacy of delivering MSCs to the CSF of people with ALS every 3 months for a total of 4 injections over 12 months. The goal of the study is to determine if this treatment is safe and can improve the subject's ALS symptoms.
Who is the study for?
This trial is for U.S. residents over 18 with ALS, diagnosed per World Federation of Neurology criteria, who can travel to the study site and follow the protocol. They must have had a stable dose of riluzole or none for at least 30 days before joining. Women should be post-menopausal, have had a hysterectomy, or use two birth control methods.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of injecting patients' own mesenchymal stem cells from body fat into their spinal fluid every three months (4 times total). These cells are thought to potentially repair nerve damage caused by ALS.See study design
What are the potential side effects?
Potential side effects may include discomfort at injection site, infection risk near the spine where injections occur, immune reactions due to cell transplantation, and general risks associated with lumbar punctures like headaches or back pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with ALS according to World Federation of Neurology criteria.
Select...
I have been diagnosed with ALS based on tests, after ruling out other causes for my weakness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Adverse Events
Secondary outcome measures
Change in slope of ALS Functional Rating Scale - Revised (ALSFRS-R)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Mesenchymal Stromal CellsExperimental Treatment1 Intervention
Autologous Adipose-derived Mesenchymal Stromal Cells (aaMSCs) will be administered intrathecally at a single dose in a volume of 5-10 mL, all patients will receive 5 x 10^7 intrathecal aaMSCs at the first injection (Visit 4). Subsequent doses may be reduced to 1 x 10^7 or increased to 1 x 10^8, based on Dose Modification Rules.
Find a Location
Who is running the clinical trial?
State of Minnesota Regenerative Medicine MinnesotaUNKNOWN
Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,709 Total Patients Enrolled
Anthony J Windebank, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are willing and able to comply with follow-up.I rely on a machine to help me breathe.I have been diagnosed with ALS according to World Federation of Neurology criteria.I have been diagnosed with ALS based on tests, after ruling out other causes for my weakness.I have been on a stable dose of riluzole for 30 days or have never taken it.I have not used Radicava® in the last 30 days and do not plan to use it during the study.I haven't had any cancer, except for minor skin cancers, in the last 5 years.I have an infection near where a spinal tap would be done.I cannot lie flat for a procedure or tolerate certain medical procedures.I have had stem cell therapy for a brain or nerve condition.I am over 18, and if female, I am post-menopausal, have had a hysterectomy, or use two forms of birth control.I have experienced a gradual increase in muscle weakness for less than 2 years.I have been on a stable dose of riluzole for at least 30 days or have never taken it.I am over 18, and if female, I am post-menopausal, have had a hysterectomy, or use two forms of birth control.I have experienced a gradual increase in muscle weakness for less than 2 years.I agree not to start new supplements during the study.I haven't had major heart issues like a heart attack or heart failure in the last 6 months.I am not using herbal medications or supplements for ALS treatment.My lung function test shows less than 65% of what's expected for someone my age, gender, and body type.I am of childbearing age and do not plan to use birth control.I have chronic low back pain that needed treatments like injections or surgery.I am not currently using, nor have I used immunosuppressant medication in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Mesenchymal Stromal Cells
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What precedents have been established with Autologous Adipose-derived Mesenchymal Stromal Cells research?
"Autologous Adipose-derived Mesenchymal Stromal Cells was initially studied in 2013 at U.O. Nefrologia e Dialisi, with 29 completed trials to date and 33 ongoing ones across multiple locations, the majority situated in Jacksonville, Florida."
Answered by AI
What is the highest number of individuals engaged in this experiment?
"This research project is no longer accepting participants. Initially posted on October 10th, 2017 and last updated on the same date in 2022, individuals searching for other studies may look into 547 clinical trials actively recruiting amyotrophic lateral sclerosis patients or 33 studies utilizing Autologous Adipose-derived Mesenchymal Stromal Cells that are still open to new recruits."
Answered by AI
Has the FDA provided its endorsement for Autologous Adipose-derived Mesenchymal Stromal Cells?
"Autologous Adipose-derived Mesenchymal Stromal Cells were given a safety rating of 2 on our 1 to 3 scale, due to the Phase 2 status of clinical trials for this medication with data supporting its safety but not efficacy."
Answered by AI
Are there any vacancies still available for the research project?
"This study, which was initially published on October 10th 2017 and last updated five years later, is not currently looking for participants. Nevertheless, there are still 580 other trials presently recruiting volunteers."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Mayo Clinic in Rochester
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Mayo Clinic in Rochester: < 48 hours
Average response time
- < 2 Days
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