Amyotrophic Lateral Sclerosis (ALS) Tissue Donation Program
Despite significant progress in the identification of mechanisms involved in motor neuron degeneration in Amyotrophic Lateral Sclerosis (ALS) and other motor system diseases, the actual pathogenesis and cause of these diseases remains unknown. Effective treatment of these diseases are dependent on the elucidation of their causes. The availability of diseased and control human tissues will be a critical resource for this research progress. . Samples of serum, spinal fluid, and urine from patients with motor system diseases can be used to study biochemical and genetic differences compared to tissues of neurologic disease controls and normal controls. Furthermore, the availability of autopsied CNS, PNS, as well as other tissues from patients with ALS or suspected ALS are useful for current and future research studies into the disease. Therefore, we propose to institute a Tissue Bank containing blood, urine, and cerebrospinal fluid donated from not only ALS and other motor neuron disease patients, but also those with other neurologic diseases and normals whose tissue can be used as controls. In addition there will be an autopsy band for post-mortem specimens of ALS and other motor neuron disease patients. Each specimen, whether from a living patient or autopsy will be de-identified and accompanied by a standard set of clinical information collected from the medical records in order that each specimen is characterized with the relevant clinical information to maximize the usefulness of the specimens.
Once established, this tissue bank will provide a resource in which a large number of samples will be readily available and expedite research by circumventing the delays in collecting specimens prospectively. These specimens will be used for research in the ALS Center of Hope at Drexel University College of Medicine and shared with any outside investigator with a valid IRB approved protocol.
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||ALS Tissue Donation Program|
- None Specified [ Time Frame: None Specified ] [ Designated as safety issue: No ]No primary outcome measure is specified for this study. Purpose of the study is to collect deidentified biological specimens which will be used to expedite other IRB approved studies.
Biospecimen Retention: Samples With DNA
Blood (Serum and DNA) Urine (Serum and DNA) CSF Blood specimens and tissue specimens (from brain, spinal cord, gastrointestinal tract, skeletal muscle and peripheral nerve)
|Study Start Date:||April 2007|
|Estimated Study Completion Date:||December 2025|
|Estimated Primary Completion Date:||December 2025 (Final data collection date for primary outcome measure)|
Diagnosed with ALS or other motor system disorder including PLS, Bulbar Palsy or Motor neuropathy
Diagnosed with other chronic neurologic illnesses (Alzheimers, multiple sclerosis, migraines, etc)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00716131
|Contact: Christine P Barr, RNfirstname.lastname@example.org|
|United States, Pennsylvania|
|MDA/ALS Center of Hope||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Christine Barr, RN 215-762-5186 email@example.com|
|Principal Investigator: Terry Heiman-Patterson, MD|
|Principal Investigator:||Terry D Heiman-Patterson, MD||Drexel University College of Medicine|