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NYSCF Scientific Discovery Biobank

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ClinicalTrials.gov Identifier: NCT06203106
Recruitment Status : Recruiting
First Posted : January 12, 2024
Last Update Posted : March 22, 2024
Sponsor:
Information provided by (Responsible Party):
New York Stem Cell Foundation Research Institute

Tracking Information
First Submitted Date January 2, 2024
First Posted Date January 12, 2024
Last Update Posted Date March 22, 2024
Actual Study Start Date November 10, 2022
Estimated Primary Completion Date November 10, 2045   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 2, 2024)		 Biobank [ Time Frame: Baseline ]
Establishment of a diverse repository of biological samples, stem cell lines, derivatives, and associated information to support investigations into the biology, etiology, manifestations, progression, risk factors, genetic underpinnings, and treatment of diseases, conditions, and traits.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title NYSCF Scientific Discovery Biobank
Official Title NYSCF Scientific Discovery Biobank
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.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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)
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).
Condition
  • 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
Intervention Other: 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).
Study Groups/Cohorts
  • Affected Subjects
    Subjects in this group will have a diagnosis and/or medical history of a condition, disease, genetic background, or trait of interest.
    Intervention: Other: Biological Sample Collection
  • Healthy Control
    Subjects in this group will serve as healthy controls.
    Intervention: Other: Biological Sample Collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 2, 2024)		 10000
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 10, 2045
Estimated Primary Completion Date November 10, 2045   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Days and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Becca Wood 212-927-1801 clinicalresearch@nyscf.org
Contact: Lisa Voltolina 646-213-3911 lvoltolina@nyscf.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT06203106
Other Study ID Numbers 10-010
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party New York Stem Cell Foundation Research Institute
Original Responsible Party Same as current
Current Study Sponsor New York Stem Cell Foundation Research Institute
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Lisa Voltolina New York Stem Cell Foundation Research Institute
PRS Account New York Stem Cell Foundation Research Institute
Verification Date March 2024