Stem Cell Therapy for ALS
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you either be on a stable dose of riluzole or not have taken it for at least 30 days before joining. You also cannot use Radicava® (edaravone) within 30 days of screening or during the study. If you're using immunosuppressants, you must stop at least 4 weeks before the screening. You must also avoid starting any new supplements during the study.
What data supports the effectiveness of the treatment Autologous Adipose-derived Mesenchymal Stromal Cells for ALS?
Research in animal models of ALS shows that adipose-derived mesenchymal stem cells can improve motor function and delay disease onset by protecting motor neurons and reducing harmful inflammation. Additionally, a case study reported long-term survival in an ALS patient who received this treatment.12345
Is stem cell therapy safe for ALS patients?
Research shows that stem cell therapy, including autologous adipose-derived mesenchymal stromal cells, is generally safe for ALS patients. Most studies report no severe side effects, although some patients experienced minor issues like chest pain or shortness of breath. Long-term monitoring indicates that the treatment is well-tolerated without accelerating disease progression.15678
How is the treatment with autologous adipose-derived mesenchymal stromal cells different from other ALS treatments?
What is the purpose of this trial?
The purpose of this study is to determine the safety and efficacy of intrathecal treatment delivered to the cerebrospinal fluid (CSF) of mesenchymal stem cells in ALS patients every 3 months for a total of 4 injections over 12 months.Mesenchymal stem cells (MSCs) are a type of stem cell that can be grown into a number of different kinds of cells. In this study, MSCs will be taken from the subject's body fat and grown. CSF is the fluid surrounding the spine.The use of mesenchymal stem cells is considered investigational, which means it has not been approved by the Food and Drug Administration (FDA) for routine clinical use. However, the FDA has allowed the use of mesenchymal stem cells in this research study.
Research Team
Nathan Staff, MD
Principal Investigator
Mayo Clinic
Anthony J Windebank, MD
Principal Investigator
Mayo Clinic
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intrathecal injections of autologous adipose-derived mesenchymal stromal cells every 3 months for a total of 4 injections over 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Autologous Adipose-derived Mesenchymal Stromal Cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
State of Minnesota Regenerative Medicine Minnesota
Collaborator