NYSCF Scientific Discovery Biobank
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT06203106 |
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Recruitment Status :
Recruiting
First Posted : January 12, 2024
Last Update Posted : March 22, 2024
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| 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 | Other: Biological Sample Collection |
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 |
| Estimated Enrollment : | 10000 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | NYSCF Scientific Discovery Biobank |
| Actual Study Start Date : | November 10, 2022 |
| Estimated Primary Completion Date : | November 10, 2045 |
| Estimated Study Completion Date : | November 10, 2045 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Affected Subjects
Subjects in this group will have a diagnosis and/or medical history of a condition, disease, genetic background, or trait of interest.
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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). |
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Healthy Control
Subjects in this group will serve as healthy controls.
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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). |
- 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.
Biospecimen Retention: Samples With DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 30 Days and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06203106
| Contact: Becca Wood | 212-927-1801 | clinicalresearch@nyscf.org | |
| Contact: Lisa Voltolina | 646-213-3911 | lvoltolina@nyscf.org |
| United States, New York | |
| New York Stem Cell Foundation Research Institute | Recruiting |
| New York, New York, United States, 10019 | |
| Contact: Becca Wood 212-927-1801 clinicalresearch@nyscf.org | |
| Contact: Lisa Voltolina 646-213-3911 lvoltolina@nyscf.org | |
| Principal Investigator: Scott Noggle | |
| Principal Investigator: | Lisa Voltolina | New York Stem Cell Foundation Research Institute |
| Responsible Party: | New York Stem Cell Foundation Research Institute |
| ClinicalTrials.gov Identifier: | NCT06203106 |
| Other Study ID Numbers: |
10-010 |
| First Posted: | January 12, 2024 Key Record Dates |
| Last Update Posted: | March 22, 2024 |
| Last Verified: | March 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 |
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Ovarian Neoplasms Uterine Cervical Neoplasms Vulvar Neoplasms Vaginal Neoplasms Uterine Neoplasms Parkinson Disease Multiple Sclerosis Alzheimer Disease Dementia Motor Neuron Disease Amyotrophic Lateral Sclerosis Huntington Disease Multiple System Atrophy Shy-Drager Syndrome Frontotemporal Dementia |
Aphasia, Primary Progressive Pick Disease of the Brain Parkinsonian Disorders Supranuclear Palsy, Progressive Lewy Body Disease Neuronal Ceroid-Lipofuscinoses Corticobasal Degeneration Macular Degeneration Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Sclerosis Atrophy Late Onset Disorders Stress Disorders, Traumatic |