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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

Must not have

Ventilator dependent

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I have been diagnosed with ALS according to World Federation of Neurology criteria.

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I have been diagnosed with ALS based on tests, after ruling out other causes for my weakness.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I rely on a machine to help me breathe.

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I have not used Radicava® in the last 30 days and do not plan to use it during the study.

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I have an infection near where a spinal tap would be done.

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I cannot lie flat for a procedure or tolerate certain medical procedures.

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I have had stem cell therapy for a brain or nerve condition.

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I agree not to start new supplements during the study.

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My lung function test shows less than 65% of what's expected for someone my age, gender, and body type.

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I am of childbearing age and do not plan to use birth control.

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I have chronic low back pain that needed treatments like injections or surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Adverse Events

Secondary study objectives

Change in slope of ALS Functional Rating Scale - Revised (ALSFRS-R)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 11Eligibility criteria met