NCT06203106

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
237mo left

Started Nov 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Nov 2022Nov 2045

Study Start

First participant enrolled

November 10, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
21.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2045

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2045

Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

23 years

First QC Date

January 2, 2024

Last Update Submit

February 27, 2025

Conditions

Keywords

ALSAmyotrophic Lateral SclerosisAlzheimer DiseaseBatten DiseaseCorticobasal DegenerationDementiaFrontotemporal DementiaHuntington DiseaseLewy Body DiseaseMultiple SclerosisMultiple System AtrophyParkinson DiseaseParkinsonismProgressive Supranuclear PalsyINADDiabetesDiabetes Type 1Diabetes Type 2Macular DegenerationWomen's Reproductive CancerOvarian CancerCervical CancerUterine CancerVaginal CancerVulvar CancerPTSDPost Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Affected Subjects

Subjects in this group will have a diagnosis and/or medical history of a condition, disease, genetic background, or trait of interest.

Other: Biological Sample Collection

Healthy Control

Subjects in this group will serve as healthy controls.

Other: Biological Sample Collection

Interventions

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 SubjectsHealthy Control

Eligibility Criteria

Age30 Days+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Stem Cell Foundation Research Institute

New York, New York, 10019, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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)

MeSH Terms

Conditions

Amyotrophic Lateral SclerosisAlzheimer DiseaseNeuronal Ceroid-LipofuscinosesCorticobasal DegenerationDementiaFrontotemporal DementiaHuntington DiseaseLewy Body DiseaseMultiple SclerosisMultiple System AtrophyParkinson DiseaseParkinsonian DisordersSupranuclear Palsy, ProgressiveDiabetes MellitusDiabetes Mellitus, Type 2Diabetes Mellitus, Type 1Macular DegenerationOvarian NeoplasmsUterine Cervical NeoplasmsUterine NeoplasmsVaginal NeoplasmsVulvar NeoplasmsStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesBrain DiseasesTauopathiesNeurocognitive DisordersMental DisordersHeredodegenerative Disorders, Nervous SystemGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLipidosesLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsLipid Metabolism DisordersFrontotemporal Lobar DegenerationBasal Ganglia DiseasesChoreaDyskinesiasMovement DisordersCognition DisordersSynucleinopathiesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesPrimary DysautonomiasAutonomic Nervous System DiseasesOphthalmoplegiaOcular Motility DisordersCranial Nerve DiseasesParalysisNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersEndocrine System DiseasesRetinal DegenerationRetinal DiseasesEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesGonadal DisordersUterine Cervical DiseasesUterine DiseasesVaginal DiseasesVulvar DiseasesStress Disorders, TraumaticTrauma and Stressor Related Disorders

Study Officials

  • Laura Andres-Martin, PhD

    New York Stem Cell Foundation Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Office

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2024

First Posted

January 12, 2024

Study Start

November 10, 2022

Primary Completion (Estimated)

November 10, 2045

Study Completion (Estimated)

November 10, 2045

Last Updated

March 3, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations