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RecruitingNCT06203106Updated Mar 3, 2025

NYSCF Scientific Discovery Biobank

An observational study in ALS, Amyotrophic Lateral Sclerosis and Alzheimer Disease, sponsored by New York Stem Cell Foundation Research Institute. Recruiting at 1 site in United States. Open to participants aged 30 Days and older. Per ClinicalTrials.gov, last updated 2025-03-03.

Sponsored by New York Stem Cell Foundation Research Institute · Observational

From the registry’s dates

  • Started Nov 2022; still recruiting 4 years later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
10,000
Ages
30 Days and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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

Keywords

  • 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
03

In context

Amyotrophic Lateral Sclerosis

978 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 277 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 108 across 265 observational studies indexed under Amyotrophic Lateral Sclerosis.

Browse Amyotrophic Lateral Sclerosis studies →

Lead sponsor

New York Stem Cell Foundation Research Institute is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Days and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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 of less than 200 cells per microliter (mcL) of blood will be excluded due to increased risk of infection.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • OtherBiological 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).

06

What researchers measure

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.

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2022 (actual). Primary completion is estimated for Nov 2045, 276 months after the start.

Of 127 non-industry observational studies under Amyotrophic Lateral Sclerosis, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 125. This study's planned 276 months is above that.

Counting every sponsor, half of 136 studies reached it within 64 months; a quarter within 29 and three quarters within 114.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 2, 2024
First posted
Jan 12, 2024
StartActual
Nov 10, 2022
Primary completionEst.
Nov 10, 2045
CompletionEst.
Nov 10, 2045
Last update
Mar 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06203106
Lead sponsor
New York Stem Cell Foundation Research Institute
Responsible party
Sponsor
First posted
Jan 12, 2024
Start date
Nov 10, 2022
Primary completion
Nov 10, 2045 (estimated)
Completion
Nov 10, 2045 (estimated)
Last update
Mar 3, 2025

Study contacts

Clinical Research Office
Contact
clinicalresearch@nyscf.org
212-927-1801
Laura Andres-Martin, PhD
principal investigator · New York Stem Cell Foundation Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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