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NCT03268603 · ClinicalTrials.gov registry record · Phase 2

Intrathecal Autologous Adipose-derived Mesenchymal Stromal Cells for Amyotrophic Lateral Sclerosis (ALS)

A Phase 2 study of Amyotrophic Lateral Sclerosis and ALS, sponsored by Mayo Clinic.

Active
Registry status
Phase 2
Development phase
75
Enrollment target
3
Study locations

NCT03268603 is a Phase 2 study of Amyotrophic Lateral Sclerosis and ALS that is active but no longer recruiting, run by Mayo Clinic. The registered enrollment target is 75 participants, below the 897-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (92% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT03268603, a Phase 2 study of Amyotrophic Lateral Sclerosis and ALS, is active but no longer recruiting, sponsored by Mayo Clinic.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
75 participants
Enrollment target
3
Study locations

Study Summary

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.

Conditions Studied

Amyotrophic Lateral Sclerosis ALS

Interventions

  • DRUG Autologous Adipose-derived Mesenchymal Stromal Cells

Study Locations (3)

Arizona

  • Mayo Clinic - Scottsdale

Florida

  • Mayo Clinic - Jacksonville

Minnesota

  • Mayo Clinic in Rochester - Rochester

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2017-10-10
Est. Completion 2026-12-31
Phase Phase 2

Sponsor

Mayo Clinic

2,844 total trials

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What the Registry Record Tells You About NCT03268603

The ClinicalTrials.gov registry entry for NCT03268603 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 897-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (92% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which Autologous Adipose-derived Mesenchymal Stromal Cells is the first listed.

NCT03268603 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Arizona, Florida, Minnesota.

Frequently Asked Questions

What is clinical trial NCT03268603 about?

NCT03268603 is a clinical study titled "Intrathecal Autologous Adipose-derived Mesenchymal Stromal Cells for Amyotrophic Lateral Sclerosis (ALS)". 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 b...

What is the current status of trial NCT03268603?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2017-10-10. Estimated completion is 2026-12-31.

What conditions does trial NCT03268603 study?

This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis, ALS.

What interventions are being tested in trial NCT03268603?

The interventions under investigation include: Autologous Adipose-derived Mesenchymal Stromal Cells (DRUG).

Who is sponsoring clinical trial NCT03268603?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03268603 being conducted?

This trial has 3 study locations across Arizona, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.