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Active, Not Recruiting

NCT Number: NCT06259500

Patient-derived Stem Cell Models of Anorexia Nervosa

Experimental and genetic data, as well as brain imaging, support a role of the hypothalamic Arcuate nucleus neurons and their communication with surrounding microglia in anorectic conditions, but it has until recently not been possible to explore these cells at a molecular level in anorexia nervosa (AN) patients. This attributed to the obvious lack of valid tissue and non-invasive imaging techniques of high enough resolution. Stem cell models have evolved as a useful tool for the exploration of other neuropsychiatric disorders with a comparably high genetic contribution as AN. The investigators will here use patient-derived induced pluripotent stem cells (iPSCs) to profile Arc neurons and peripheral blood mononuclear cell (PBMC) derived microglia in AN, thus defining molecules to explore as drug targets.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Karolinska Institutet

Stockholm, 17176, Sweden

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

anorexia nervosa:

  • female
  • 18-45 years of age
  • AN restrictive diagnosis as main diagnosis
  • more than 5 years duration

Exclusion criteria

anorexia nervosa:

-

Inclusion criteria

healthy control:

  • female
  • 18-45 years of age
  • BMI 18,5 - 25

Exclusion criteria

healthy control:

  • own or family member with eating disorder diagnosis
  • own or family member with autism diagnosis

Treatment and study plan

Observational

Other

Profiling the function of iPSC derived Arcuate neurons and PBMC derived microglia

Primary outcomes

  1. Microglia function and transcriptomic profiling

    Time frame: 2025

    phagocytic and immune activation capacity and whole transcriptomic profiling, anorexia nervosa vs healthy controls

  2. Arcuate neuron function and transcriptomic profiling

    Time frame: 2026

    Electrical activity, transmitter release and whole transcriptomic profiling of iPSC derived Arcuate neurons, anorexia nervosa vs healthy controls

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Generation and Analysis of Patient-derived Stem Cell Models of Hypothalamic Neurons and Microglia in Anorexia Nervosa

Acronym: ANSTEM

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 14, 2024
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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