Clinical Trials

4 studies in Lou Gehrig's Disease

1. A Longitudinal Study of Amyotrophic Lateral Sclerosis (ALS) Biomarkers Jacksonville, FL View Summary
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   A Longitudinal Study of Amyotrophic Lateral Sclerosis (ALS) Biomarkers

   Location:

   Jacksonville, FL

   Trial status:

   Open for Enrollment

   Why is this study being done?

   The purpose of the research study is to collect blood samples and cerebrospinal fluid (CSF) from people with amyotrophic lateral sclerosis (ALS). These samples will be collected approximately every 4 months.

   NCT ID:

   NCT01495390

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   Who can I contact for additional information about this study?

   
   
   Jacksonville: Karen Overstreet 904-953-8946
                       
   

2. A Dose-escalation Safety Trial for Intrathecal Autologous Mesenchymal Stem Cell Therapy in Amyotrophic Lateral Sclerosis Rochester, MN View Summary
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   A Dose-escalation Safety Trial for Intrathecal Autologous Mesenchymal Stem Cell Therapy in Amyotrophic Lateral Sclerosis

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   The primary objective of this study is to determine the safety of intrathecal delivery of autologous mesenchymal stem cells (MSCs) to the cerebrospinal fluid (CSF) of patients with ALS using a dose-escalation study. The trial will include 25 adult, non-ventilator-dependent patients with clinically definite amyotrophic lateral sclerosis (ALS). Cells will be isolated from adipose tissue, expanded ex vivo and then, after ~8 weeks, intrathecal (IT) autologous delivery of MSCs will be performed. There will be 5 treatment groups of up to 5 patients each. Groups 1, 2, and 4 will receive a single dose of cells. Groups 3 and 5 will receive 2 doses of cells separated by 1 month. Groups will be completed sequentially so that patients will not be enrolled into the next treatment group until at least 3 patients in the preceding group have completed the treatment and 1 month of additional observation without significant toxicity. All patients will be followed on a regular basis until death or for a minimum of 2 years after completion of the final infusion. Initial clinical follow-up will be weekly with scheduled blood, CSF and magnetic resonance imaging (MRI) evaluations. After 1 month, patients will have clinical evaluations at 3 month intervals, or earlier if indicated by clinical status.

   NCT ID:

   NCT01609283

   IRB Number:

   11-008415

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   Who can I contact for additional information about this study?

   Rochester: Anthony J. Windebank, MD 507-284-2511
                       Nathan P. Staff, MD, PhD 507-284-2511
   
   
   

3. DNA, Blood and Skin Cell Repository for Research on ALS and Related Neurodegenerative Disorders at Mayo Clinic Florida Jacksonville, FL View Summary
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   DNA, Blood and Skin Cell Repository for Research on ALS and Related Neurodegenerative Disorders at Mayo Clinic Florida

   Location:

   Jacksonville, FL

   Trial status:

   Open for Enrollment

   Why is this study being done?

   This study is intended to obtain clinical information and establish a repository of DNA, RNA, peripheral blood monocyte, lymphocyte and skin tissue samples from people with ALS and related neurodegenerative motor neuron diseases, people with a family history of these conditions, and healthy people with no family history of these disorders. The samples will be used in future research to learn about how these disorders affect people, what causes these conditions, and how the investigators can tell when someone has this kind of disease. Future research may also include the generation of stem cells from stored blood cell and skin cell samples.

   NCT ID:

   NCT01699451

   IRB Number:

   12-004718

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   Who can I contact for additional information about this study?

   - Mayo Clinic Cancer Center - Phone: 507-538-7623 - Research Volunteer Program - Phone: 1-800-664-4542 (toll-free) Email: clinicaltrials@mayo.edu - International Research - Phone: 507-284-8884 Email: intl.mcr@mayo.edu

4. MCF Post Mortem Tissue Repository for Research on ALS Jacksonville, FL View Summary
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   MCF Post Mortem Tissue Repository for Research on ALS

   Location:

   Jacksonville, FL

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Limited availability of post mortem tissue from people with amyotrophic lateral sclerosis (ALS) and clinically unaffected family members is a significant constraint in the field of ALS research. Analysis of post mortem brain, spinal cord, and potentially other organs facilitates research to determine the causes of ALS, ALS with frontotemporal dementia (ALS-FTD), and other motor neuron diseases. This study is intended to establish a process in the Mayo Clinic Florida ALS Center for collection of post mortem brain, spinal cord, and other tissues, including internal organs and skin samples, to support future research studies on ALS and related neurodegenerative disorders.

   IRB Number:

   12-007795

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   Who can I contact for additional information about this study?

   Kristin Staggs 4500 San Pablo Road Jacksonville, Florida 32224 904-953-6523