Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 2 study of Amyotrophic Lateral Sclerosis and ALS, sponsored by Mayo Clinic.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The number of adverse events experienced by subjects
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2017-10-10 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What the registry record for NCT03268603 still lists
NCT03268603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 897-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (92% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Amyotrophic Lateral Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03268603's enrollment target sits among peer trials
75 47th of 102 higher than 56 of 102 other Amyotrophic Lateral Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyotrophic Lateral Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Dazucorilant in Patients With Amyotrophic Lateral Sclerosis
RECRUITING · Phase 2
-
HEALEY ALS Platform Trial - Master Protocol
RECRUITING · Phase 2
-
RAPA-501 Therapy for ALS
RECRUITING · Phase 2
-
A Study of Ranolazine in ALS
RECRUITING · Phase 2
-
Rho Kinase Inhibitor in Amyotrophic Lateral Sclerosis (REAL)
ACTIVE NOT RECRUITING · Phase 2
-
Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01535430 · 75 participants
Assessment of Eloquent Function in Brain Tumor Patients
- NCT01542879 · 75 participants · Phase 1
Development of Radiation Free Whole Body Magnetic Resonance (MR) Imaging Technique for Staging Children With Cancer
- NCT02232191 · 75 participants · Phase 2
Immunologic Response to Pneumococcal Polysaccharide Vaccine in Splenic Injury Patients
- NCT02754544 · 75 participants · NA
Electrocorticography in Mapping Functional Brain Areas During Surgery in Patients With Brain Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI