Clinical trial NCT06203106: NYSCF Scientific Discovery Biobank
Official title: NYSCF Scientific Discovery Biobank
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ALS
Amyotrophic Lateral Sclerosis
Alzheimer Disease
Alzheimer Disease, Early Onset
Alzheimer Disease, Late Onset
Batten Disease
Corticobasal Degeneration
Dementia
Frontotemporal Dementia
Huntington Disease
Lewy Body Disease
Multiple Sclerosis
Multiple System Atrophy
Parkinson Disease
Parkinson's Disease and Parkinsonism
Progressive Supranuclear Palsy
INAD
Diabetes
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Macular Degeneration
Ovarian Cancer
Cervical Cancer
Uterine Cancer
Vaginal Cancer
Vulvar Cancer
PTSD
Post Traumatic Stress Disorder
Keywords: ALS
Amyotrophic Lateral Sclerosis
Alzheimer Disease
Batten Disease
Corticobasal Degeneration
Dementia
Frontotemporal Dementia
Huntington Disease
Lewy Body Disease
Multiple Sclerosis
Multiple System Atrophy
Parkinson Disease
Parkinsonism
Progressive Supranuclear Palsy
INAD
Diabetes
Diabetes Type 1
Diabetes Type 2
Macular Degeneration
Women's Reproductive Cancer
Ovarian Cancer
Cervical Cancer
Uterine Cancer
Vaginal Cancer
Vulvar Cancer
PTSD
Post Traumatic Stress Disorder
Lead sponsor: New York Stem Cell Foundation Research Institute
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 10000
Sex: ALL
Minimum age (years): 30
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with a diagnosis of one or more of the listed conditions. Individuals without a condition to serve as healthy controls (a comparison group for those with conditions).

Brief summary: The New York Stem Cell Foundation (NYSCF) Research Institute is performing this research to accelerate diverse disease research using cells from the body (such as skin or blood cells) to make stem cells and other types of cells, conduct research on the samples, perform genetic testing, and store the samples for future use.

Through this research, researchers hope to identify future treatments or even cures for the major diseases of our time.

Detailed description: Researchers at the New York Stem Cell Foundation (NYSCF) Research Institute study diverse diseases, conditions, and traits by creating stem cells from biological samples. These "pluripotent" stem cells can become any cell in the human body, including cells that may be difficult, invasive, or impossible to obtain directly.

Additionally, researchers perform genetic testing to learn more about DNA, a material in most cells that contains instructions for the body's development and functions (such as traits like eye color and risk of certain diseases). A piece of DNA that determines the specific role of a cell is called a "gene." If the instructions in a gene are abnormal, this can lead to disease.

Participation in the study involves: (1) completion of health questionnaires, (2) providing a skin and/or blood sample from which stem cells may be created, (3) collection of a saliva sample for genetic analysis, and (4) possible future followup to provide additional information or learn about other research studies.

This study is not a clinical trial.

Eligibility criteria: Inclusion Criteria:

* Age 30 days or older.
* Diagnosis and/or medical history of a condition, disease, genetic background, or trait of interest or healthy control.
* Adults with decisional capacity must provide written informed consent unless physical limitations preclude signing.
* Adults without decisional capacity to consent must a have diagnosis of Amyotrophic Lateral Sclerosis (ALS), Alzheimer's Disease and Related Dementias (AD/ADRD); Batten Disease, Corticobasal Degeneration (CBD), Dementia, Frontotemporal Dementia (FTD), Huntington Disease, Lewy Body Disease, Multiple Sclerosis, Multiple System Atrophy, Parkinson's Disease (PD), Parkinsonism, and/or Progressive Supranuclear Palsy, and must provide assent; a legally authorized representative (LAR) must also provide written informed consent.
* Minors undergoing skin collection for research purposes must have a condition, disease, genetic background, or trait of interest and parental/guardian consent.
* Minors undergoing blood, and/or saliva collection for research purposes may have a condition, disease, genetic background, or trait of interest or serve as a healthy control and must have an available parent/guardian to provide consent.
* Minors transferring biological samples and associated data from a procedure outside of the research may have a condition, disease, genetic background, or trait of interest or serve as a healthy control and must have an available parent/guardian to provide consent.

Exclusion Criteria:

* Wards of the state.
* For prospective skin samples: history of keloid formation, coagulation disorder, or allergy to the anesthetic.
* For prospective blood samples: history of coagulation disorder.
* For all prospective sample collections: 1) Subjects who refuse to adhere to NYSCF's and/or a collection site's safety protocol(s) will be excluded; 2) Subjects with an AIDS diagnosis and CD4 count of less than 200 cells per microliter (mcL) of blood will be excluded due to increased risk of infection.

Primary outcomes:
measure: Biobank
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Stem Cell Foundation Research Institute
state: New York
Study officials:
affiliation: New York Stem Cell Foundation Research Institute
name: Laura Andres-Martin, PhD
role: PRINCIPAL_INVESTIGATOR
References: