Recruiting

Observational Study

Sponsor:

New York Stem Cell Foundation Research Institute

Code:

NCT06203106

Conditions

ALS

Amyotrophic Lateral Sclerosis

Alzheimer Disease

Alzheimer Disease, Early Onset

Alzheimer Disease, Late Onset

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Biological Sample Collection

Study Details

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.

Conditions

ALS

Amyotrophic Lateral Sclerosis

Alzheimer Disease

Alzheimer Disease, Early Onset

Alzheimer Disease, Late Onset

Study ID

NCT06203106

Start date

Nov 10, 2022

Status verified date

Feb, 2025

Completion date

Nov 10, 2045

Anticipated

Primary completion date

Nov 10, 2045

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

Affected Subjects

Subjects in this group will have a diagnosis and/or medical history of a condition, disease, genetic background, or trait of interest.

Healthy Control

Subjects in this group will serve as healthy controls.

Interventions

Biological Sample Collection

Skin biopsy (2-3mm) and/or blood (up to 50 mL); saliva; excess/ leftover biospecimens that were (or will be) collected for other purposes (e.g., medical procedure).

Primary outcome measure

  • Biobank [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Clinical Research Office

212-927-1801clinicalresearch@nyscf.org

Locations

New York Stem Cell Foundation Research Institute

Recruiting

New York, New York, United States, 10019

Contacts

Clinical Research Office

212-927-1801clinicalresearch@nyscf.org

Principal Investigator:

Laura Andres-Martin, PhD

More Information

Sponsor

New York Stem Cell Foundation Research Institute

Last update posted

Mar 3, 2025

Last verified

Feb, 2025

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York Stem Cell Foundation Research Institute on 2025-03-03.