- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04270604
Biological Sample Collection for Research and Biobanking
The New York Stem Cell Foundation (NYSCF) Research Institute is performing this research to study different conditions and diseases by using cells from the body (such as skin or blood cells). NYSCF uses these samples to make stem cells and other types of cells, conduct research on the samples, perform genetic testing, and/or store these samples for future use.
Through this research, scientists hope to identify future treatments or even cures.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Researchers at NYSCF study diverse diseases, conditions, and traits by creating "pluripotent" stem cells. These stem cells can become any cell in the human body, including cells that may be difficult, invasive, or even impossible to obtain directly. For example, researchers may create pancreatic insulin-producing cells to learn more about type 1 diabetes, or brain cells to learn more about Parkinson's disease.
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 a health questionnaire, (2) providing a skin and/or blood sample from which stem cells may be created, (3) possible collection of a saliva sample for genetic analysis, and (4) possible future follow-up to provide additional information or learn about other research studies.
This study is not a clinical trial.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Clinical Research Office
- Phone Number: 212-927-1801
- Email: clinicalresearch@nyscf.org
Study Locations
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-
New York
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New York, New York, United States, 10019
- New York Stem Cell Foundation Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Individuals with a diagnosis of one or more of the listed conditions.
Individuals with a known genetic mutation, with or without a diagnosed condition.
Individuals without a genetic mutation or condition to serve as healthy controls (a comparison group for those with conditions).
Description
Inclusion Criteria:
Age
- 18 years or older or
- Minor with parent/guardian consent
Biological Sample Collection
Able and willing to provide:
- new samples of blood, skin, and/or saliva specifically for use in this study and/or
- excess/leftover samples, cell lines, and/or derivatives that were (or will be) collected for reasons other than this study
Exclusion Criteria:
- Non-English speaking
- Wards of the state
- For skin samples collected specifically for this study: history of keloid formation, bleeding disorder, allergy to the anesthetic, or anticoagulation use that precludes sample collection.
- For blood samples collected specifically for this study: bleeding disorder, or other medical condition, if the subject's condition increases the risks associated with blood collection.
- For saliva samples: inability to produce sufficient saliva or has a condition that precludes sample collection (such as severe trismus).
- For prospective samples: refuse to adhere to NYSCF's and/or collaborating site's COVID-19 safety protocols during the COVID-19 pandemic.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Establishment of a diverse bank of biological samples, stem cell lines, derivatives, and associated information.
Time Frame: Baseline
|
There are no primary endpoints planned for this biobank; endpoints will be specific to research projects that utilize samples/data contained in the biobank.
Projects may investigate the biology, etiology, manifestations, progression, risk factors, genetic underpinnings, and treatment of diseases, conditions, and traits.
|
Baseline
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Scott Noggle, PhD, New York Stem Cell Foundation Research Institute
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
- Mental Disorders
- Glucose Metabolism Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Immune System Diseases
- Autoimmune Diseases
- Eye Diseases
- Neurocognitive Disorders
- Endocrine System Diseases
- Diabetes Mellitus
- Retinal Degeneration
- Retinal Diseases
- Genetic Diseases, Inborn
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Dyskinesias
- Heredodegenerative Disorders, Nervous System
- Dementia
- Tauopathies
- Cognition Disorders
- Chorea
- Macular Degeneration
- Diabetes Mellitus, Type 1
- Parkinson Disease
- Alzheimer Disease
- Huntington Disease
Other Study ID Numbers
- 10-005
- 20112091 (Other Identifier: WCG IRB)
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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