- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06203106
NYSCF Scientific Discovery Biobank
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.
Study Overview
Status
Conditions
- PTSD
- Multiple Sclerosis
- Cervical Cancer
- Diabetes Mellitus, Type 2
- Diabetes Mellitus
- Diabetes
- Macular Degeneration
- Diabetes Mellitus, Type 1
- Parkinson Disease
- Amyotrophic Lateral Sclerosis
- Dementia
- Ovarian Cancer
- Alzheimer Disease
- ALS
- Vulvar Cancer
- Post Traumatic Stress Disorder
- Lewy Body Disease
- Multiple System Atrophy
- Corticobasal Degeneration
- Frontotemporal Dementia
- Progressive Supranuclear Palsy
- Huntington Disease
- Alzheimer Disease, Early Onset
- Alzheimer Disease, Late Onset
- Vaginal Cancer
- Parkinson's Disease and Parkinsonism
- Batten Disease
- Uterine Cancer
- INAD
Intervention / Treatment
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Becca Wood
- Phone Number: 212-927-1801
- Email: clinicalresearch@nyscf.org
Study Contact Backup
- Name: Lisa Voltolina
- Phone Number: 646-213-3911
- Email: lvoltolina@nyscf.org
Study Locations
-
-
New York
-
New York, New York, United States, 10019
- Recruiting
- New York Stem Cell Foundation Research Institute
-
Contact:
- Becca Wood
- Phone Number: 212-927-1801
- Email: clinicalresearch@nyscf.org
-
Contact:
- Lisa Voltolina
- Phone Number: 646-213-3911
- Email: lvoltolina@nyscf.org
-
Principal Investigator:
- Scott Noggle
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy Control
Subjects in this group will serve as healthy controls.
|
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).
|
Affected Subjects
Subjects in this group will have a diagnosis and/or medical history of a condition, disease, genetic background, or trait of interest.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lisa Voltolina, New York Stem Cell Foundation Research Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- PTSD
- Multiple Sclerosis
- Diabetes
- Amyotrophic Lateral Sclerosis
- ALS
- Dementia
- Alzheimer Disease
- Cervical Cancer
- Progressive Supranuclear Palsy
- Corticobasal Degeneration
- Parkinson Disease
- Ovarian Cancer
- Multiple System Atrophy
- Huntington Disease
- Diabetes Type 1
- Diabetes Type 2
- Uterine Cancer
- Macular Degeneration
- Frontotemporal Dementia
- Post Traumatic Stress Disorder
- Vaginal Cancer
- Vulvar Cancer
- Parkinsonism
- Batten Disease
- Lewy Body Disease
- INAD
- Women's Reproductive Cancer
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Immune System Diseases
- Neoplasms
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Eye Diseases
- Neurologic Manifestations
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Endocrine System Diseases
- Disease Attributes
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Retinal Degeneration
- Retinal Diseases
- Endocrine Gland Neoplasms
- Genetic Diseases, Inborn
- Neuromuscular Diseases
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Pathological Conditions, Anatomical
- Dyskinesias
- Trauma and Stressor Related Disorders
- Spinal Cord Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Metabolism, Inborn Errors
- Heredodegenerative Disorders, Nervous System
- Lipid Metabolism Disorders
- Tauopathies
- Cognition Disorders
- Cranial Nerve Diseases
- Autonomic Nervous System Diseases
- Ocular Motility Disorders
- Vaginal Diseases
- Vulvar Diseases
- Language Disorders
- Communication Disorders
- Lipidoses
- Lipid Metabolism, Inborn Errors
- Paralysis
- Speech Disorders
- Primary Dysautonomias
- Hypotension
- Frontotemporal Lobar Degeneration
- Ophthalmoplegia
- Chorea
- Aphasia
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Multiple Sclerosis
- Sclerosis
- Uterine Cervical Neoplasms
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Macular Degeneration
- Diabetes Mellitus, Type 1
- Parkinson Disease
- Stress Disorders, Traumatic
- Stress Disorders, Post-Traumatic
- Motor Neuron Disease
- Amyotrophic Lateral Sclerosis
- Dementia
- Ovarian Neoplasms
- Alzheimer Disease
- Vulvar Neoplasms
- Atrophy
- Lewy Body Disease
- Multiple System Atrophy
- Shy-Drager Syndrome
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
- Parkinsonian Disorders
- Supranuclear Palsy, Progressive
- Huntington Disease
- Late Onset Disorders
- Vaginal Neoplasms
- Uterine Neoplasms
- Neuronal Ceroid-Lipofuscinoses
- Corticobasal Degeneration
Other Study ID Numbers
- 10-010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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