NYSCF Scientific Discovery Biobank

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

NYSCF Scientific Discovery Biobank

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06203106
• Other study ID #: 10-010
• Status: Recruiting
• Start date: November 10, 2022
• Est. completion date: November 10, 2045

Study information

• Verified date: March 2024
• Source: New York Stem Cell Foundation Research Institute
• Contact: Becca Wood
• Phone: 212-927-1801
• Email: clinicalresearch[@]nyscf.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: November 10, 2045
• Est. primary completion date: November 10, 2045
• Gender: All
• Age group: 30 Days and older

Eligibility

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.

Related Conditions & MeSH terms

• ALS
• Alzheimer Disease
• Alzheimer Disease, Early Onset
• Alzheimer Disease, Late Onset
• Amyotrophic Lateral Sclerosis
• Aphasia, Primary Progressive
• Atrophy
• Batten Disease
• Cervical Cancer
• Corticobasal Degeneration
• Dementia
• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Frontotemporal Dementia
• Huntington Disease
• INAD
• Lewy Body Disease
• Macular Degeneration
• Motor Neuron Disease
• Multiple Sclerosis
• Multiple System Atrophy
• Neuronal Ceroid-Lipofuscinoses
• Ovarian Cancer
• Ovarian Neoplasms
• Parkinson Disease
• Parkinson's Disease and Parkinsonism
• Parkinsonian Disorders
• Pick Disease of the Brain
• Post Traumatic Stress Disorder
• Progressive Supranuclear Palsy
• PTSD
• Sclerosis
• Shy-Drager Syndrome
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Supranuclear Palsy, Progressive
• Uterine Cancer
• Uterine Cervical Neoplasms
• Uterine Neoplasms
• Vaginal Cancer
• Vaginal Neoplasms
• Vulvar Cancer
• Vulvar Neoplasms

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).

Locations

Country	Name	City	State
United States	New York Stem Cell Foundation Research Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Stem Cell Foundation Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biobank	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.	Baseline